Archive for the ‘Hormone Clinic’ Category

Human Growth Hormone and Testosterone Therapy in New JerseyHGH Testosterone Treatment Centers & Doctors in NJTestosterone Therapy in New Jersey

Men's HGH and Testosterone levels decline as they age and it could specifically be Low Testosterone that is causing excessive weight gain, loss of sex drive, softer than normal erections, flabby muscles, unexplained mood swings, irritability, extreme fatigue, inability to sleep and depression. If your testosterone is low enough you may already have symptoms of erectile dysfunction or Andropause (Low T - the male menopause).

Both HGH and Testosterone decline with age. As men age testosterone levels naturally drop causing adverse health issues. It is a gradual, slow process and so you may have not noticed less sexual arousal, softer erections or less morning erections, shorter night's rest, moodiness and increasing bursts of anger, or the inability for your muscles to recover after working out.Most middle-aged men do notice, however, the rapid increase in weight and fat around the mid-section, flabby muscles, extreme fatigue, erectile dysfunction and feelings of depression that may be caused by hormonal imbalance or deficiency.

Human Growth Hormone Treatment using Somatropin HGH, is a safe and effective hormone treatment method for growth hormone deficiency, also known as AGHD. HGH Therapy is bio-identical or natural hormone optimization used by Endocrinologists and Anti-Aging Doctors who measure your level of hormone deficiency, and prescribe Somatropin which is a subcutaneous daily injection of Human Growth Hormone. Injectable HGH is the best form of HGH Therapy. For those patients who do not qualify for HGH Injections Therapy, Sermorelin Therapy using GHRH Peptide Injections is available. Read more about Sermorelin Injections online.

In addition to Injectable HGH or Somatropin for hormone replacement, other HRT programs include Testosterone Injections and Creams, Bio-Identical HRT, Low T Therapy, Sermorelin Injections, Sexual Health and Wellness, ED Therapy, Menopause Therapy, Stress & Weight Loss Management, IV Infusion Vitamin Therapies, Chelation and Testosterone Treatments, providedin New Jersey by Board Certified Licensed Age Management Physicians who are Cenegenics, Mayo Clinic and Cleveland Clinic trained in Anti-Aging and Regenerative Medicine with a focus on "Healthy Aging".

Our Hormone Replacement Physicians provide hormone optimization, life extension, nutritional and anti-aging therapies to men and women residing in the USA.

HGH Brands for sale in the USA include Pfizer Genotropin, MiniQuick Pen, Sandoz Omnitrope, Novo Nordisk Norditropin, FlexPro Pen, NordiFlex Pen, and Eli Lilly Humatrope. Somatropin, the genuine injectable growth hormone comes in a vial HGH kit, or cartridge for use with an HGH pen device.

In addition to Hormone Treatment Programs using Injectable HGH for bio-identical hormone replacement, other HRT and TRT Programs include Combination HGH and Testosterone Treatment Plans using Testosterone Injections including Depo-Testosterone Steroid Hormone Shots, Delatestryl and Aveed, Topical Androgen Creams and Androgen Gels such as AndroGel, Fortesta, Axiron and Testim, Low T Treatment Programs with HCG and AI's Aromatase Inhibitiors (Arimidex), HCG Injections with Testosterone and Somatropin; Sermorelin Acetate Peptide Injections, GHRP-6 and GHRP-2 Hexapeptide Therapy.

Sexual Health and Wellness Programs for Men & Women, ED Treatment Programs using vasodilators and prostaglandin penile injections such as BiMix, Trimix Injections, Caverject, Edex and LI Shockwave Therapy for ED (male impotence ultrasound treatment), Menopause Treatment Programs for women using estrogen replacement, progesterone, oxytocin, and Female Sexual Health Programs including testosterone for women to boost libido and sexual arousal; Stress, Obesity & Medical Weight Loss Programs, Vitamin IV Infusion Therapies; Bio-Identical Hormone Programs are formulated by Endocrinologists, Urologists and Anti-Aging Medicine Doctors providing natural hormone optimization, Healthy Aging Programs, Life Extension and Longevity Programs, nutrition, fitness and anti-aging therapies to men and women residing in New Jersey.

Men or women experiencing low energy, loss of sex drive or sexual dysfunction, rapid or excessive weight gain, Low T levels, loss of muscle mass due to low testosterone, extreme fatigue, inability to sleep, hot flashes, joint pain, slow recovery from workouts, lack of enthusiasm for life, irritability, mood swings or depression.

If you are looking to restore your energy levels and get back your enthusiasm for living, boost your sex drive, increase lean muscle mass, lose excess body fat and weight, trim your waist, reduce stress, sleep better, improve your vision and memory, reduce wrinkles, thicken your hair, look younger and feel younger - fill out the Quick Info Form for a Free HRT Doctor's Consultation.

At Optimal Hormone Therapy Center, we have served over 20,000 hormone patients and can offer you the absolute best service and pricing on HRT Therapy including Testosterone Injections and HGH Injections.

Contact us to find the various Hormone Lab Testing facilities to qualify for Anti Aging, Testosterone, HGH and HCG treatments if you live throughout the area of New Jersey

At Optimal Hormone Therapy Centers, we specialize in testosterone and HGH replacement therapy. You will be carefully listened to, all your questions answered, and closely monitored for any signs and symptoms or side effects. Your testosterone and HGH (IGF-1) levels and other necessary hormone blood levels will be thoroughly measured. Low Testosterone and Human Growth Hormone Deficiency are legitimate medical health conditions whose diagnosis affects a lot of men and women nationwide. The HRT physicians at Optimal Hormone Therapy Centers fully understand that not all family doctors or general practitioners are trained in bio-identical hormone therapy or comfortable treating individuals with low testosterone or and HGH deficiency.At our Testosterone and HGH clinics our experienced doctors recognize that optimal hormone levels are the goal and key to vitality and healthy aging.

209 Lefante Way,Bayonne, NJ 7002

1011 Clifton AvenueClifton, NJ 7013

1139 Main Avenue,Clifton, NJ 7015

118 South Ave EastCranford, NJ 7016

313 South Avenue,Fanwood, NJ 7023

301 Bridge Plaza North,Fort Lee, NJ 7024

1025 W Saint Georges Avenue,Linden, NJ 7036

22 Old Short Hills Road,Livingston, NJ 7039

2040 Millburn Ave Ste 203 204Maplewood, NJ 7040

25 East Willow Street,Millburn, NJ 7041

1 Greenwood Ave Ste 102Montclair, NJ 7042

345 Henry Street,Orange, NJ 7050

3219 US Highway 46,Parsippany, NJ 7054

464 Valley Brook AvenueLyndhurst, NJ 7071

349 Valley Street,South Orange, NJ 7079

2333 Morris Avenue,Union, NJ 7083

3196 Kennedy Blvd.,Union City, NJ 7087

45 Academy Street,Newark, NJ 7102

41-51 Wilson Avenue,Newark, NJ 7105

600 Pavonia Avenue,Jersey City, NJ 7306

522 Central Avenue,Jersey City, NJ 7307

25-15 Fair Lawn Avenue,Fair Lawn, NJ 7410

1031 Mcbride Avenue,West Paterson, NJ 7424

503 North Franklin Turnpike,Ramsey, NJ 7446

401 Goffle Road,Ridgewood, NJ 7450

38 Hamburg Turnpike,Riverdale, NJ 7457

11 Boulder Hills Blvd.,Wantage, NJ 7461

Viking Village Route 94,Vernon, NJ 7462

307 Hamburg Turpike,Wayne, NJ 7470

170 Prospect Avenue,Hackensack, NJ 7601

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Common New Jersey Testosterone Searches: New Jersey Hormone Therapy, Andropause Treatment NJ, Men's Clinic in Newark, New Jersey Male Anti-Aging, Testosterone Replacement Therapy Atlantic City NJ, Elizabeth Testosterone Center, HGH Replacement Therapy Hollywood New Jersey, Jersey City Low T, Trenton Low T, Human Growth Hormone Newark New Jersey, Parsippany NJ, Human Growth Hormone Replacement Therapy, Hackensack NJ Testosterone Clinics; Secaucus New Jersey Testosterone Replacement Therapy, Low Testosterone Therapy Hoboken New Jersey, Testosterone Replacement Therapy New Jersey, North Bergen Testosterone Replacement Therapy; TRT Alpine Replacement Therapy, Growth Hormones Therapy; HGH Camden, Newark New Jersey Testosterone Replacement Therapy, Saddle River NJ Testosterone Replacement Therapy. HGH Replacement Therapy Atlantic City New Jersey.

Low Testosterone due to Andropause is a treatable and reversible male health condition. You needn't let Low T impact your self-esteem, your work life or your romantic relationships. You don't need to suffer, Male Hormone Therapy can help. If you are among the millions of men experiencing symptoms of low testosterone, get tested and treated today.

The physicians at Optimal Hormone Therapy are Cenegenics and Mayo-Clinic trained. Our doctors are nationally recognized experts in the field of hormone replacement therapy. If you think you may be suffering from low testosterone, schedule an appointment to have a complete and thorough analysis of your health. Once completed we will decide together with you which type of treatment is right for you.

Rejuvenate yourself and your health. Testosterone Replacement Therapy can restore your sex drive and desire, lose weight and increase your energy, mental alertness, strength and stamina.

Call Optimal Hormone Therapy at (888) 663-1777 to find out if you are a candidate for testosterone replacement therapy and other hormone enhancing treatments.

Human Growth Hormone (Somatropin Injections).

HGH Growth Hormone Replacement Therapy.

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HGH and Testosterone Therapy Clinics in New Jersey ...

AAI Rejuvenation Clinic is breaking the mold. In a very short period, we have brought our ranking position to be noted as one of the best hormone health centers in existence. A quick Google search for best hormone clinic in the country yields first page results containing AAI Clinics as one of the first brick and mortar locations available for selection.

AAI Rejuvenation Clinic is a hormone clinic. No, hormones are not only for athletes or the elderly. That is a huge misconception keeping millions of people away from enjoying their happiest and healthiest life possible.

Patients do not only receive hormones You cannot help heal 1 million different peoples health problems with a group of only 15 basic medications and hormones. Other compounds are necessary and vary from person to person. We supply these.

Therapy-supporting nutraceuticals Depending on patient goals and individual ailments, targeted supplements are also prescribed to maximize results and the efficiency of therapy. We practice focused healing and goal achieving.

Most competitive pricing in the industry From inception, we have known this industry is saturated with overpriced margins. We knew providing exceptional patient care in conjunction with the best available pricing was an impermeable recipe for everybodys success.

Healing from the core Foods are medicine. We provide information on symptom-focused healing foods, including viable recipes and food per item nutritional details and medicinal property explanations. Eating the right foods to heal your body and reach your goals is one of the biggest kept secrets, yet fastest ways to obtain lasting results.

Hassle free

1. Patients only need three simple documents for qualification. 2. Patients never need to leave their city. 3. Individualized assistance via assigned medical professional 7 days a week from 9 AM to 10 PM EST. 4. Prescription fills delivered to home or office in discrete packaging.5. Prescribing Physicians online or phone consults available. 6. For our busy patients, a physicians visit to their home or office can be organized.

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AAI Rejuvenation Clinic - Best Hormone Clinic in the USA ...

Thyroid Hormone Disorder Drug Market

DataIntelo, 14-05-2020: The research report on the Thyroid Hormone Disorder Drug Market is a deep analysis of the market. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. Experts have studied the historical data and compared it with the changing market situations. The report covers all the necessary information required by new entrants as well as the existing players to gain deeper insight.

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Thyroid Hormone Disorder Drug Market 2020 Global Share, Growth, Size, Opportunities, Trends, Regional Overview, Leading Company Analysis And Forecast...

Abstract: 5514

NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) is shown to significantly improve overall survival (OS) compared to ADT alone, in men with non-metastatic castration-resistant prostate cancer (nmCRPC).1 These data from the pre-specified final OS analysis of the Phase III ARAMIS trial will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, which takes place from May 29-31, 2020.

Previously published results in 1,509 patients from the Phase III ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months (n=955) with NUBEQA plus ADT, compared to 18.4 months (n=554) for placebo plus ADT (p<0.001); however OS data were not yet mature at the time of the MFS analysis.2 MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Adverse reactions occurring more frequently in the NUBEQA arm (2 percent over placebo) were fatigue (16 percent versus 11 percent), pain in extremity (6 percent versus 3 percent) and rash (3 percent versus 1 percent).2 NUBEQA was not studied in women and there is a warning and precaution for embryo-fetal toxicity.2

"Men with nmCRPC typically do not have cancer symptoms. In selecting a treatment for these patients, my goal as a clinician is to improve their overall survival while limiting side effects and drug interactions," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, Villejuif, France. "These data add to the growing evidence for darolutamide as an effective treatment option with proven tolerability that extends patients lives and delays cancer symptoms."

Final OS Analysis Presented at ASCO Virtual Scientific Program

Men receiving NUBEQA plus ADT showed a statistically significant improvement in the secondary endpoint of OS compared to ADT alone, with a 31 percent reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003).1

With extended follow-up, any grade treatment-emergent adverse events (AEs) at final analysis were generally consistent with the primary analysis of the Phase III ARAMIS trial.1,2 Previously, in the primary analysis, any grade AEs occurred in 83.2 percent who received NUBEQA plus ADT and 76.9 percent who received ADT alone.2 Grade 3 or 4 AEs occurred in 24.7 percent who received NUBEQA plus ADT and 19.5 percent who received ADT alone.2 Grade 5 AEs occurred in 3.9 percent who received NUBEQA plus ADT and 3.2 percent who received ADT alone.2 Serious AEs occurred in 24.8 percent receiving NUBEQA plus ADT and in 20.0 percent receiving ADT alone.2 The percentage who discontinued the trial regimen because of AEs was 8.9 percent in the NUBEQA plus ADT group and 8.7 percent in the ADT group.2

Previously, OS data were not mature at the time of MFS analysis (57 percent of the required number of events).2 Secondary endpoints were evaluated in a hierarchical order, with a significance level of 0.05 split between the primary analysis and final analysis (planned to occur after 240 deaths from any cause) of secondary endpoints.1,2 The endpoint OS was used to determine the alpha spend and significance threshold for each of the secondary endpoints.2 Given the OS analysis did not meet the threshold for statistical significance, this prevented all of the secondary endpoints from meeting the criteria for statistical significance at the interim analysis.2

In the follow-up analysis of the same secondary endpoints, all were statistically significant.1 NUBEQA plus ADT showed statistical significance in delaying time to pain progression (HR=0.65, 95% CI 0.53-0.79; p<0.001), time to first initiation of treatment with cytotoxic chemotherapy (HR=0.58, 95% CI 0.44-0.76; p<0.001) and time to first symptomatic skeletal event (SSE) (HR=0.48, 95% CI 0.29-0.82; p=0.005) versus ADT alone.1

Time to pain progression was defined as at least a 2-point worsening from baseline of the pain score on Brief Pain Inventory-Short Form or initiation of opioids, in patients treated with NUBEQA as compared to ADT alone. Pain progression was reported in 28 percent of all patients at the interim analysis.

Story continues

About NUBEQA (darolutamide)3

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.3 A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about this trial can be found at http://www.clinicaltrials.gov.

On July 30th, 2019, the FDA approved NUBEQA (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with nmCRPC who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily or ADT alone. The primary efficacy endpoint was MFS.

Adverse reactions occurring more frequently in the NUBEQA arm (2 % over placebo) were fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%). NUBEQA was not studied in women and there is a warning and precaution for embryo-fetal toxicity.

Developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, NUBEQA is indicated for the treatment of men with nmCRPC.3 The approvals of NUBEQA in the U.S., European Union (EU), Australia, Brazil, Canada, and Japan have been based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of NUBEQA plus ADT compared to ADT alone.3 Filings in other regions are underway or planned.

INDICATION

NUBEQA is approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).3

IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in 1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (2% over placebo) were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%) and rash (3% vs. 1%).

Clinically significant adverse reactions occurring in 2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs. 3.4% on placebo) and heart failure (2.1% vs. 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure, which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure, which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs NUBEQA is an inhibitor of breast cancer resistance protein (BCRP) transporter. Concomitant use of NUBEQA increases the exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. Consult the approved product labeling of the BCRP substrate when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.4 In 2020, about 192,000 men in the U.S. will be diagnosed with prostate cancer and an estimated 33,000 will die from the disease.5 Prostate cancer is the fifth leading cause of death from cancer in men.4 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a mans reproductive system.6 It mainly affects men over the age of 50, and the risk increases with age.7

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.8 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.9

Castration-resistant prostate cancer (CRPC) is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly for CRPC patients who have prostate cancer that has not spread to other parts of the body with rising prostate-specific antigen (PSA) levels despite a castrate testosterone level, which is called non-metastatic castration-resistant prostate cancer, or nmCRPC.10,11 About one-third of men with nmCRPC go on to develop metastases within two years.12 In men with progressive nmCRPC, a short PSA doubling time is correlated with shortened time to first metastasis and death.11

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the companys approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to http://www.bayer.us.

2020 BayerBAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayers public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

_______________________________________________________________________________________________

References

PP-NUB-US-0303-1

05/20

View source version on businesswire.com: https://www.businesswire.com/news/home/20200513005848/en/

Contacts

Media Contact:Rose Talarico, Tel. +1 862.404.5302 E-Mail: rose.talarico@bayer.com

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NUBEQA (darolutamide) Plus Androgen Deprivation Therapy Showed a Statistically Significant Improvement in Overall Survival with Proven Efficacy and...

New York University (NYU) Langone researchers find that elevated levels of toxic chemicals from pesticides, nonstick cookware, and fire retardants are associated with an increased risk of developing celiac disease.

Celiac disease is an autoimmune disease where the ingestion of gluten leads to damage in the small intestines, Dr. Patrick Fratellone, RH FIM, an integrative physician and adjunct professor at the University of Bridgeport College of Naturopathic Medicine, told Healthline.

For this study published May 11 in the journal Environmental Research, researchers examined levels of toxic chemicals in the blood of 30 children and young adults, from 3 to 21 years old, and recently diagnosed with celiac disease at NYU Langone Hassenfeld Childrens Hospital.

Chemical levels were compared to those of 60 other participants of similar age, gender, and race without celiac disease.

The NYU team discovered that children and young adults who have high levels of pesticides and other chemicals called dichlorodiphenyldichloroethylenes (DDEs) had double the chance of being diagnosed with celiac disease than those who didnt.

The study also found that gender plays a role in how chemicals influence celiac risk.

For females, higher-than-normal pesticide exposure meant they were at least eight times more likely to become gluten intolerant.

But elevated levels of nonstick chemicals (perfluoroalkyls, or PFAs), including products like Teflon, were up to nine times more likely to have celiac disease.

On the other hand, young males with elevated blood levels of fire-retardant chemicals called polybrominated diphenyl ethers (PBDEs) were only twice as likely to be diagnosed with the condition.

The endocrine system, also called the hormone system, is made up of glands located throughout the body.

Theres emerging science that certain chemicals disrupt immune function, and not just hormonal function, said study co-investigator and health epidemiologist Dr. Leonardo Trasande, MPP, professor of pediatrics at NYU Langone.

He added theres already some suggestive evidence that endocrine-disrupting chemicals contribute to celiac disease and are associated with other diseases, like Crohns disease.

Trasande emphasized theres a lot of cross-talk between the endocrine system and the immune system, in the context of celiac disease and other autoimmune conditions.

According to the Environmental Protection Agency (EPA), persistent organic pollutants (POPs) include thousands of synthetic chemicals widely used during the industrial production boom after the Second World War.

Although many POPs have been phased out of use, these chemicals remain in the environment, as they are resistant to degradation and tend to accumulate in animal and human tissue, the study authors wrote.

Some well-known POPs include polychlorinated biphenyls (PCBs), the pesticide DDT, and dioxins which come from chlorine bleaching of paper pulp, the manufacturing of some herbicides and pesticides, and other industrial processes.

DDE is a metabolite of the long-standing pesticide DDT, which of course has been banned, except for some use in malaria prevention in parts of Africa, said Trasande. But theres legacy contamination, such that we werent surprised to detect many of the metabolites [in study participants].

He emphasized that there are steps we can take to reduce our exposure to these chemicals.

People can do things like simply clearing the air by opening windows every day, and using a wet mop to sop up persistent pollutants that can accumulate in dust.

Trasande asserted that this study adds to others raising concerns about nonstick chemicals.

One simple way to cut down on exposure to these chemicals is to switch out Teflon pans for cast-iron pans, which if properly seasoned can result in a nonstick like surface without these chemicals.

This isnt the first study to find a link between commonly used chemicals and celiac disease.

A 2013 study published in the journal Interdisciplinary Toxicology concluded that glyphosate, the active ingredient in herbicides like Roundup, is the most important causal factor in celiac disease.

But Trasandes study is the first to measure an association between chemical exposure and the condition.

Our study establishes the first measurable tie-in between environmental exposure to toxic chemicals and celiac disease, said senior study investigator and pediatric gastroenterologist Dr. Jeremiah Levine in a statement. These results also raise the question of whether there are potential links between these chemicals and other autoimmune bowel diseases, which all warrant close monitoring and further study.

The National Institutes of Health (NIH) list symptoms of celiac disease that include:

However, some people with the disease may not have symptoms at all. According to the NIH, celiac disease can also prevent children from absorbing nutrients, which may lead to issues like slowed growth, weight loss, damaged tooth enamel, and delayed puberty.

It affects 1 in 100 individuals, said Fratellone. These individuals are genetically predisposed, and it is estimated that there are over 2 million Americans who are undiagnosed and at risk for long-term complications,

Fratellone explained that gluten is an umbrella name for proteins known as prolamins, which are primarily made up of glutenin and gliadin. This substance is found in grains that include wheat, rye, and barley.

The best way to treat a celiac patient is to educate him or her on avoiding wheat gluten. There are also blood tests to determine if you have a gluten allergy or have celiac disease, he said.

The Mayo Clinic cautions that before starting a gluten-free diet, you should be tested for celiac disease first because eliminating gluten could make the tests appear normal.

There are two blood tests available to diagnose it: serology testing, which looks for certain antibodies in your blood, and genetic testing. Some gastroenterologists believe you must have a biopsy. I do recommend food allergy testing, said Fratellone.

If youre gluten intolerant, the Mayo Clinic advises you to avoid all foods and drinks containing wheat, rye, barley, triticale (a cross between wheat and rye), and in some cases, oats, if there is a chance they were contaminated during production with gluten-containing grains.

For the first time, a study has measured the association between exposure to toxic chemicals, like pesticides and industrial chemicals, and celiac disease risk.

Researchers say that the findings raise the question of whether there are potential links between these chemicals and other autoimmune bowel diseases.

Celiac disease can lead to serious health issues in children, but experts say its important to get tested before starting a gluten-free diet.

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Pesticides, Nonstick Pans and Celiac Disease: How They Are Linked - Healthline

High blood pressure gradually increases the pressure of blood flowing through your arteries. Over time, this pressure can cause your arteries to lose their elasticity and narrow. Flexible arteries allow blood to flow unimpeded to vital organs so if the channel becomes rigid, this restricts the amount of blood flowing around the body.

Eventually, the heart may be starved of the blood it needs to function - this could trigger a heart attack.

Unfortunately, there is no obvious way of spotting this process.

To stave off the threat of high blood pressure, you must therefore take proactive steps to keep your reading in check.

It is well documented that committing to healthy lifestyle decisions, such as eating a healthy, balanced diet and exercising regularly, will keep your blood pressure under control.

READ MORE: High blood pressure warning - the exercise you should avoid or risk deadly hypertension

Evidence has also identified some novel ways of lowering blood pressure.

An unusual activity that stands out is listening to classical music.

A small study, published in journal Deutsches Arzteblatt International, found that listening to Mozart for 25 minutes reduced high blood pressure in participants.

The research found that listening to music by Mozart and Strauss for 25 minutes lowered both systolic blood pressure and diastolic blood pressure.

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Systolic and diastolic blood pressure are the two numbers used to record your blood pressure.

Systolic blood pressure, which indicates how much pressure your blood is exerting against your artery walls when the heart beats, is generally regarded as more important because it indicates your risk of heart disease.

The benefits listening to music brought to blood pressure were not confined to classical music, however.

If particularly regularly listened to Mozart, Strauss or ABBA it still reduced their blood pressure in the study, although pop music seemed to have a more modest effect.

Listening to Mozart or Strauss reduced their systolic blood pressure by 4.7mmHg and 3.7mmHg and diastolic blood pressure by 2.1mmHg and 2.9mmHg.

In contrast, music by ABBA reduced systolic blood pressure by a modest 1.7mmHg and had a very small effect on diastolic blood pressure.

Strengthening the finding, levels of the stress hormone cortisol fell in all three groups.

According to Mayo Clinic, hormones such cortisol temporarily increase your blood pressure by causing your heart to beat faster and your blood vessels to narrow.

The researchers suggested that, in order for music to reduce blood pressure, it should have no lyrics, have few changes in volume or rhythm, have harmonies that "are not rousing", and that certain parts of the music should be repeated in intervals.

General tips to lower blood pressure

According to the NHS, general tips to lower blood pressure include:

Cut your salt intake to less than six grams (0.2oz) a day, which is about a teaspoonful find out how you can reduce the amount of salt in your diet

"You can take these steps today, regardless of whether or not you're taking blood pressure medicines," says the NHS.

It adds: "In fact, by making these changes early on you may be able to avoid needing medicines."

Read more:
High blood pressure: Listen to this genre of music for 25 minutes a day to lower reading - Express.co.uk

This research report covers all the quantitative as well as qualitative aspects about the Endometriosis Therapies markets across the globe. The report is also inclusive of different market segmentation, business models and market forecasts. This market analysis enables the manufacturers with impending market trends. A thorough scrutiny of prominent market players or industrialists are vital aspects for planning a business in the market. The Global Endometriosis Therapies market report covers deep insights of various vital aspects of the market. Moreover, in past few years, the market of Endometriosis Therapies has recorded a significant development and is anticipated to further rise.

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Market research report for every industry is based on various important factors, for example demand & supply, market trends, revenue growth patterns and market shares. Report on the Global Endometriosis Therapies market is made after a comprehensive research conducted by a systematized methodology. These techniques are helpful for analyzing the market on the terms of research guidelines. Basically, research reports covers all the information about the consumers, vendors, manufactures, research papers, products and many more. They provide a range of marketing as well as business research solutions basically designed for the readers looking forward to invest in the market. Also, study about the rivals enables in attaining valuable data about the strategies, companys models for business, revenue growth as well as statistics for the individuals attracted towards the market. This report is very useful for the new entrants as it offers them with the idea about the different approaches towards the market.

Major companies of this report:

Endometriosis TherapiesAbbVieEli LillyAstraZenecaBayerAstellas PharmaMeditrina PharmaceuticalsPfizerNeurocrine BiosciencesTakeda Pharmaceutical

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This section majorly focuses over several developments taking place in the region including substantial development and how are these developments affecting the market. Regional analysis provides a thorough knowledge about the opportunities in business, market status & forecast, possibility of generating revenue, regional market by different end users as well as types and future forecast of upcoming years.

Segmentation by Type:

Hormonal ContraceptivesGonadotropin-releasing Hormone (Gn-RH) AgonistsProgestin TherapyAromatase Inhibitors

Segmentation by Application:

HospitalClinicOther

The Global Endometriosis Therapies market research report delivers deep insights about the different market segments based on the end-use, types and geography. One of the most crucial features of any report is its geographical segmentation of the market that consists of all the key regions. The key factor important for making any new business effective is advancement or making impactful modifications in the business. Report on Global Endometriosis Therapies market, is an extensive papers that covers all the aspects of the market analysis and enables a comprehensive summary to its readers. In a nutshell, the Endometriosis Therapies market research reports is a one-stop solution for all requirements by the in-house experts.

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Global Endometriosis Therapies Market Research Report 2020, Segment by Key Companies, Countries, Types, Applications and Forecast 2021 to 2026 - Cole...

According to latest figures, it is estimated that 1 in 6 Irish couples trying to conceive will now have difficulty becoming pregnant.

However, natural Fertility Specialist, Jessica Bourke wants women to be more informed so they can take back the power when it comes to their fertility and avoid unnecessary issues that could cause heartache and stress down the line.

One aspect of this, is knowing the basic tests you and your partner can do to get a snapshot into your fertility and at what point you need to seek further assistance.

While it is personal preference, Jessica admits that ideally couples should consider basic tests before trying to concieve. I would say get your full bloods done, check youre both in good health, that there is no secondary health conditions.

The blood tests are about 30 in your GP, thats nothing in comparison to fertility treatment down the line. So I would be of the belief that it's better to be safe than sorry.

So what tests should you have done? Women who have a regular cycle should get the day 3 and 21 blood tests to assess their hormonal balance (i.e. FSH, LH and oestradiol on day 3, progesterone on day 21), Jessica advises.

However, she notes that for those with a history of PCOS or an irregular cycle, it would be best to proceed with the day 3 bloods, with the addition of prolactin and testosterone, to see if those hormones are raised, as this could impact your ability to ovulate.

Both men and women should also request a standard full blood count, with the addition of vitamin D. While men should also request a semen analysis combined with sperm DNA fragmentation testing.

The AMH test, which has long been a popular tool in assessing a womans fertility, has become increasingly controversial, and Jessica thinks the value of this test has been greatly overstated.

I get messages from women all the time panicking about AMH results. Its so important women understand that AMH is just one teeny tiny part of the puzzle she explains.

The AMH result can go up, as well as down, contrary to what you may have been told.

It only provides you with a vague approximation of egg quantity, it tells you nothing about the quality of your eggs, which is what really matters when trying to conceive.

I had a woman last year whose AMH was 6, which was low, but in six months after minding her diet and doing acupuncture it went up to 12.5 and that is far from an isolated case Ive seen that a number of times over my career.

Ive had so many women in front of me in tears, thinking they need to get donor eggs, or that they need to freeze their eggs.

"This is often times, unfounded, so its important to get a full picture of your fertility potential. The AMH is just a snapshot.

Follicle tracking scans can be as much, if not more useful than the AMH test says Jessica, as it shows you how many antral follicles are developing on given cycle, as well as whether the lining is thickening as it should be and being able to see if you actually ovulated.

The AMH test is variable, which means that the same woman could see different AMH levels, within the same menstrual cycle.

"A low AMH reading can cause pronounced anxiety for many women and it is not on that women are being unnecessarily scaremongered about their fertility when I have not seen that to be the case" she says.

"The biggest misconception is that women think that it means their eggs are bad, that is not true. This is a test that is of huge profit and gain to the fertility industry and thats what it is about, you have young women being left terrified so they go in and freeze their eggs."

"If they go for IVF and they have low AMH they might be told to go for donor eggs, thats more money for the clinics.

"I'm sorry to be cynical about it but its absolutely madness that any clinic should be encouraging women to freeze their eggs based on one test."

"If your AMH result is particularly good for your age, then it would be important to rule out any tendency towards PCOS, as this is a gynaecological condition that if evident, could hamper your fertility potential."

Jessica is keen to stress that AMH is just one hormone. There are many others to consider, which would have a bearing not just on your ability to conceive, but also on whether you could be at an increased risk for miscarriage. For example, thyroid markers, prolactin, testosterone, cortisol, DHEA, melatonin, FSH, LH, oestradiol, progesterone etc.

"I had a case about two years ago with a couple, where the women at 33 years old had been told she needed to go for donor eggs" Jessica reveals.

"And I asked the partner about his sperm tests and he had been told his DNA fragmentation was high but the clinic said they would work with it. When I saw the results, his results were 42%, anything over 30% is considered severe."

"I said no sorry guys the problem guys here is the sperm. And he immediately said he had brought up a bad kick he got years earlier playing football and a whole litany of health issues he had over the years."

"That is the level of diservice that is being done to women. So women really need to get that message that the AMH is just one part of the picture. Im not saying it is useless but it is very unwise to make a big decision about your fertility based on just one marker."

The standard advice is to seek help if youve been trying to conceive for a year and are under 35, or if youve been trying for 6 months and are over 35 says Jessica.

However, she advises that it really depends on the invididual couple.

"If you have a history of gynaecological issues, whether it be chronic UTIs, PCOS, endometriosis, or indeed, any other chronic health issue e.g. auto-immune conditions, hypothyroidism, known blood clotting issues etc. then I would recommend seeking help at the 3-6 month mark, regardless of your age" she says.

"Over 80% of couples are typically pregnant within 1 year of trying, so there is usually only cause for concern once it goes over that time-frame."

"Im not saying it is useless but it is very unwise to make a big decision about your fertility based on just one marker" says Jessica.

"Never panic when it comes to anything to fertility In my line of work, it has been the case that there is always something that can be done. In 15 years Ive only had one case where the male and the female both had extremely complicated genetic issues."

"If a man gets a DNA fragmentation test and its bad dont panic.However, the clinics will say theres nothing they can do about the sperm but its fine because they can do ICSI or screen the embryos."

"However that is nonsense, you have to find out the reason why. All the background health issues, any medication they are on, past injuries, if there is any infection in the body, if there is inflammation in the area. There are multitudes of things that can be ruled out. But men have more control when they realise there is a lot they can do about it, and big improvements can be made with diet and lifestyle too."

"With fertility we are always looking for that smoking gun", Jessica admits. "'Oh it's the sperm or its the AMH level', but its very rare that I see just one factor. In 90 per cent the cases I deal with it is a combination of smaller factors."

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Basic fertility tests your GP can do, when they need to be done and what the results can tell you - RSVP Live

In a new episode of his Instagram series 'Conscious Living', Novak Djokovic spoke with countryman Dr. Dragan Ivanov about the benefits of healthy eating. But the Serb also made some interesting revelations about his own diet - including the fact that he has made a habit out of starving himself.

Novak Djokovic shared a video of the interaction on his profile, saying that he was happy to learn the basics of diet and nutrition from Dr. Ivanov.

The English translation of the said post written in Serbian reads:

Professor Ivanov, a vegetarian, informed Novak Djokovic about the foods that are best for the brain, and also said that breakfast is the most important meal of the day. The specialist in internal medicine further stated that a vegetarian diet is the best source of energy and protein for the body.

During the chat with Dr. Ivanov, Novak Djokovic talked about the unusual dietary practices he follows in order to achieve peak fitness.

Despite being a top athlete who needs heavy doses of energy, Djokovic said that he goes 16 hours without eating everyday. This is part of a process called 'autophagy', and it has seemingly been working wonders for Djokovic over the last one and a half years.

The 33-year-old told Dr. Ivanov:

It has been medically proven by Japanese Nobel laureate Yoshinori Oshumi that after 12 to 16 hours of starvation,the process of autophagy begins. In this process, the body starts consuming its own tissue for metabolism, which in turn has a healing effect on the individual.

On being asked about his views on autophagy, Dr. Ivanov elaborated:

Dr. Ivanov further stated that autophagy is turned 'on' at night, when the body secretes a hormone called melatonin due to the intestine being empty.

Novak Djokovic's comments about autophagy or self-starving are the latest in a series of seemingly bizarre revelations over the last few weeks.

In a chat with Chervin Jafarieh last week, Djokovic said the molecular structure of water can be changed through emotions. And a few days before that he had expressed reservations about the coronavirus vaccine being made mandatory for ATP players, prompting many to believe he is an anti-vaxxer.

This latest revelation, however, might be the least controversial of all. Djokovic's claims are backed by the findings of a Nobel Prize-winning scientist, and the Serb also has his unreal fitness on the court to show for his efforts.

Novak Djokovic has also been following a plant-based diet over the last few years.

It seems that the Serb has arrived at the perfect dietary combination for his body: veganism paired with regular fasting or starving. And considering he has become the World No. 1 and a 17-time Slam champion through this unusual regimen, many other athletes might follow in his footsteps soon.

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Novak Djokovic reveals he goes 16 hours without eating everyday - Sportskeeda

Global Facial Injectable Market Trends, Growth and Share Analysis by Type (Botulinum Toxin, Hyaluronic Acid, Polymers and Particles and Collagen), Application (Facial Line Correction Treatment, Face Lift and Lip Treatments), End User (Hospitals, Specialty Clinics and Spa & Beauty Clinic) and Region (North America, Europe, Asia-Pacific and Middle East & Africa) Forecast till 2025

Thefacial injectable market analysisis been driven by numerous factors. However rising proportion and absolute numbers of older people led by baby boomers generation with good incomes are the critical driving factor for the global facial injectable market. According to the World Health Organization estimates between 2015 and 2050, the proportion of the worlds population over 60 years will double from 12% to 22% which will be a positive development for the market.

Another critical driver and the motive behind the market is the primal desire to remain young. The extension of life has been a primal desire of humanity and a mainstay motif in the history of scientific pursuits and ideas throughout history, from the Egyptian Smith medical papyrus, Ayurveda practitioners, alchemists, etc. This primal desire for youth has driven the market for anti-ageing drugs since time immemorial.

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Anti-ageing, face rejuvenation and cosmetic treatments have changed the rules of engagement and reinvention. Today, its possible to change the basic elements of yourself to fulfil the basic desire of humans to be young.

The growing influence of lifestyle, fashion and film industry have led to rising demand of medications to slow the ageing and its signs. Health and youth wellness have become a status symbol and youthful appearance is penetrating peoples life and there is increasing consumerization of youth. The growth of media such as television and lifestyle magazines have led to a craze for youthful appearance.

Other driving factors are primal desire of humans to remain young, influence of lifestyle industry and rising awareness about wellbeing, high levels of disposable incomes etc. The market restraints are skepticism and concerns of safety regarding the unrestricted use of anti-ageing drugs without greater and clearer experimental validation. Ambiguity of the definition of anti-ageing drugs is also a cause of concern. For example, numerous cosmetics have been included or claimed to have anti-aging effects and have been termed as Cosmeceuticals. Cosmeceutical is defined by the cosmetic industry as cosmetic products that have medicinal or drug like effects which is not supported by the U.S. Food and Drug Administration (FDA) or the Food, Drug and Cosmetic Act.

The facial injectable market is a technological oriented market having a high research and development potential due to advancement in technologies and cellular understanding which are keys to unravel the exact mechanism of ageing. Gene therapy, stem cell technology and targeted delivery of nutrients using biotechnology are expected to open the gates for anti-ageing drugs. The development of biomarkers for physiochemical modifications in the body such as alteration of concentration of an enzyme or hormone provides another exiting avenue for the future market. For example, levels of homocysteine has been proposed as a marker of age related changes in the body so as to compensate the change by drugs.

From a market perspective the facial injectable market is ripe with mergers, acquisitions and partnerships. For example, in 2017, cosmetic giant LOral acquired skincare brands such as CeraVe, AcneFree and Ambi from Valeant Pharmaceuticals at ~ $1.25 billion. In 2016, Johnson & Johnson acquired Vogue International LLC, for greater than $3 billion to strengthen its consumer segment. Thus, partnerships seem to be a good strategy to curtail the developmental cost of any new facial injectable drug. Acquisition of other companies also leads to expansion of product lines which improves market penetration and exposure.

The global market for facial injectable is expected to reach USD 9.04 billion by the end of the forecasted period 2023 and is expected to grow at a CAGR of 13.2%

Global facial injectable market is segment by types and applications. Based on types the market is sub-segmented as botulinum toxin, hyaluronic acid, polymers & particles, and collagen. On the basis of application, the market is sub-segmented into facial line correction treatment, face-lift, lip treatments and others.

The key players in his market are Allergan, Galderma, Integra Lifesciences, Merz Pharma, Sanofi, SciVision Biotech Inc, Sinclair. Suneva Medical and Valeant Pharmaceuticals.

Regional outlook for the facial injectable market

Thefacial injectable marketis dominated by North America. The U.S. is the prime mover of the facial injectable market. However, it has to be noted that Latin America despite its lower per capita income has a disproportionate share of the market. It is estimated that Latin America will be the fastest in the future. As of the present the European regions is expected to be the second largest market globally, with countries like Germany, UK and France playing a prominent role in the market. Germany accounts for both the largest and the fastest growing nation in the European region facial injectable market, followed by France.

Asia Pacific market is expected to be the fastest future growing market during the forecast period 2016-2023. The Asia Pacific region will be led by countries such as China and India. However the greatest hindering reasons for the Asia pacific region market is the poor per capita income and the high cost of treatment. Nations such as Thailand etc. have a disproportionate share of Asia Pacific market considering their low income as compared to the U.S. The market of these nations is influenced to a considerable degree by the tourism and fashion industry. Advertisement and greater exposure seems to be the best strategy to be a market leader along with product development. The return on investment for advertisement and publicity is very high for the cosmetic surgery market.

There has been a definite shift of the cosmetic surgery market from the developed regions to the developing ones particularly Latin America and Asia Pacific countries such as Thailand. The market represents a clustered outlook with urban metropolitan cities especially with adjoining tourism and fashion industry having an extreme lead over the rural areas. Large tourism clusters such as Miami, Bangkok, Bali etc. have a disproportionate share of the market due to the large volume of cosmetic surgeries.

The porn industry also is affecting the market and it has been seen that the rise of cosmetic surgeries has a linear relationship with the quality and bandwidth of the internet. Thus cities such as Los Angeles, Las Vegas etc. are the leading clusters of cosmetic surgery market.

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Facial Injectable Market Analysis Landscape, Overview and Segmentation | Forecast to 2025 - stopthefud

Treatment of metastatic hormone receptor (HR)-positive, HER2-negative breast cancer is traditionally executed with the use of endocrine therapy. With the emergence of targeted therapies for the treatment of this disease, however, the landscape is rapidly shifting, and more therapies are under active research.

In the current landscape, oncologists have made room for CDK4/6 inhibition in combination with endocrine therapy, a combination that has been proven to improve upon progression-free and overall survival in this patient population.

At this point in time, we're grateful to have CDK4/6inhibition as our standard of care, but there is so much work going on and so many exciting new agents. What I what to think about is what lies ahead in the next decade in terms of the introduction of a lot of these newer agents into our clinics, Erica Mayer, MD, toldTargeted Oncology.

A new clinical trial is underway (PACE, NCT03147287) to further investigate CDK4/6 inhibition in combination with endocrine therapy after chemotherapy. In 3 arms of fulvestrant monotherapy, fulvestrant plus palbociclib, and fulvestrant plus palbociclib with avelumab (Bavencio), the study is primarily assessing progression-free survival (PFS), with overall response rate and treatment-emergent adverse events as secondary end points.

In an interview withTargeted Oncology, Mayer, senior medical oncologist, Breast Oncology Center, Dana-Farber Cancer Institute, discussed advances in the treatment landscape of HR-positive, HER2-negative breast, primarily with endocrine therapy and CDK4/6 inhibition.

TARGETED ONCOLOGY: Can you discuss advances in endocrine therapy in recent years and explain what you see for the future of endocrine therapy in advanced HR+, HER-negative breast cancer?

Mayer: Over the past several decades, we have primarily been using endocrine monotherapy to treat metastatic hormone receptor positive breast cancer. However, over the past several years weve had the introduction of new targeted therapies that we used in combination with an endocrine back bone, and the introduction of these agents has substantially improved progression free and overall survival for patients with metastatic hormone receptor positive HER2-negative disease. We had the introduction of the mTOR inhibitor everolimus, and the CDK4/6 inhibitors, palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio), as well as the most recent from 2019, a PI3 kinase inhibitor, alpelisib (Piqray).

At this point in time, there are at least 8 large randomized studies that have looked at the addition of a CDK4/6 inhibitor to back on endocrine therapy, either in the first- or second-line settings. There are trials that have used all 3 available agents and the diversity of endocrine back bone. Importantly and consistently, there is a substantial improvement in hazard ratio across the board of 0.5 to .055,which suggests a doubling and PFS with the addition of the CDK4/6 inhibitor, and that has become our standard of care for the majority of patients in the first-line or second-line settings.

In the past year, weve seen overall survival (OS) data from these agents and again, suggesting that there may be an OS advantage from the use CDK4/6 inhibitors and supporting the upfront use of these agents. The big question that has come up, though, is after a CDK4/6 inhibitor, if the cancer is progressing, what do we give next? What are our next best strategies? Should we be continuing on a CDK4/6 inhibitor like we would do with trastuzumab in HER2-positive breast cancer, or should we be switching to a different endocrine therapy with a new targeted partner? Also, how can we best select that targeted partner?

In terms of the idea of maintaining CDK4/6 inhibition, there are multiple studies ongoing trying to address this question. We are fortunate to lead a study called PACE, which is a randomized study open throughout the United States, in which patients who have progressed on a CDK4/6 inhibitor are then randomized to 1 of 3 arms, fulvestrant alone, which could be standard of care and many patients, fulvestrant with the CDK4/6 inhibitor, palbociclib, or a triplet combination of fulvestrant, palbociclib, and avelumab, which is an immunotherapy agent. This study is based off of some strong preclinical data and is actively accruing. Were hoping that will help address this question.

Beyond that, there has been research to understand mechanisms of resistance to CDK4/6 inhibitors and dissect that from known mechanisms of resistance to endocrine therapy. Ideally, we would love to think of a framework where we could, in real time, test the tumor or even test circulating tumor DNA to identify the mutation that is the cause of the resistance. Then we can apply a new targeted therapy with the next line of endocrine treatment to overcome that resistance. There are several candidates, therapies, and mechanisms which have been identified.

At this point in time, were grateful to have CDK4/6 inhibition as our standard of care, but there is so much work going on and so many exciting new agents. What I what to think about is what lies ahead in the next decade in terms of the introduction of a lot of these newer agents into our clinics.

TARGETED ONCOLOGY: With all the different agents that are available in the space, how do you determine which patients are eligible for which therapies?

Mayer: The paradigm of which treatment we give at which step in time has been something that's been changing a bit recently. As I mentioned, the first line of therapy that most patients will now be receiving would be in endocrine therapy with a CDK4/6 inhibitor, and I think it is important to note that in years past when patients showed evidence of what we think of as visceral disease, there may have been a tendency to start those patients with chemotherapy. Thats not necessary. We can give them endocrine therapy with a CDK4/6 inhibitor, which has a high response rate and a very favorable PFS and is much better tolerated than chemotherapy. This needs to be the standard of care for the vast majority of patients.

Following that, we're increasingly going to see the introduction of tumor genomics to help us identify mutations. We have 1 actionable mutation right now, which is a mutation in PIK3CA. For patients who have that mutation, the use of alpelisib may be an attractive way to go. However, for those who don't have a PIK3CA mutation, at this point in time, we have our standard endocrine therapies, and we also have everolimus. With ongoing trials were going to start to see some interesting new options for the other categories of mutations.

TARGETED ONCOLOGY: What is the key takeaway?

Mayer: The key takeaway is that none of these advances could have happened without laboratory discovery, translation to the clinic, and the completion of clinical trials. I think that for us to move as a field we need to help design the best possible trials. We need to support them all by structuring and running the trials. Importantly, all providers and patients need to work together to enter these trials and complete them and get answers these questions.

TARGETED ONCOLOGY: What accessible are some of these available agents?

Mayer: The majority of agents that I have discussed in the standard setting are FDA-approved.

These drugs that should be available to any patient, wherever they are in the United States. The availability outside the United States varies depending on each country's approval status.

Clinical trials are a challenge that our community needs to work on. Many clinical trials are available at the large academic medical centers and increasingly, trials could be open through our cooperative networks at community cancer centers or at satellite hospitals close to the larger centers. We still have many patients in this country who live very far away from institutions that have trials available for them, and I think we need to work harder to community oncologists and every breast cancer patient.

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Improving Upon Treatment Standards in HR+ Breast Cancer - Targeted Oncology

Getting your period during a pandemic is like a movie scene where characters acknowledge their plight and say, At least things cant get worse. Getting a yeast infection and period double-whammy right now, though? Thats the moment that comes right after that scene, when it starts to rain.

As unpleasant as it may be to experience the irritation of a yeast infection alongside period cramps and other symptoms, your period shouldnt have too much of an effect on how you treat and get rid of your yeast infection. Hopefully, this is particularly comforting to hear when heading to your health care providers office might not be as simple as it used to be, and stressing over anything can feel more intense than normal. If you suspect youre suddenly dealing with both a yeast infection and your period, keep reading for some insight on why this might be happening and what you can do about it.

The fungus that most often causes yeast infections is known as Candida albicans, and it occurs naturally in the body, including in the vagina. Usually, bacteria called Lactobacillus prevent this fungus from growing out of control. But sometimes this yeast has a chance to grow unchecked and cause a yeast infection, which is usually characterized by itching, irritation, and a cottage cheese-like discharge.

This overgrowth can happen for a few reasons, including using antibiotics that throw off your vaginal flora, hormone fluctuations, health conditions like uncontrolled diabetes, or even lifestyle habits like regularly wearing your sweaty workout clothes for way too long, according to the Mayo Clinic. In any case, rest assured that yeast infections are incredibly common. In fact, 75 percent of women report getting a yeast infection at some point, with many experiencing at least two infections in their lifetimes, the Mayo Clinic notes. Basically, youre in great (and probably also very annoyed) company.

While most people dont regularly get yeast infections simultaneously with their periods, its definitely possible to have both at once, Taraneh Shirazian, M.D., a gynecologist and assistant professor in the Department of Obstetrics and Gynecology at NYU Langone Health, tells SELF. This is because hormones, vaginal pH, and bacteria levels can all fluctuate in the time leading up to your period, making it easier for yeast to grow too much, H. Frank Andersen, M.D., a clinical education director and ob/gyn in the Department of Medical Education and Clinical Sciences at Washington State University, tells SELF.

More specifically, an increase in estrogen in the days before your period could predispose you to a yeast infection/menstruation combo. A significant enough uptick in estrogen is a known risk factor for yeast infections; high levels of estrogen appear to lower vaginal pH, causing it to become more acidic in a way that makes it easier for yeast to overgrow to the point of infection.

Even if youre on a combined hormonal contraceptive that suppresses this kind of natural hormonal fluctuation, the estrogen in your birth control itself can also increase your risk of a yeast infection, the Mayo Clinic says. There is also research to indicate that levels of Lactobacillus drop during your period, which causes vaginal pH to become more acidic.

Luckily, Dr. Andersen notes that theres no reason to worry that your period will make the yeast infection any worse, symptomatically speaking. You might be more annoyed, of course (see the aforementioned rain metaphor), but the fact that youre menstruating shouldnt extend or exacerbate the infection. With treatment and time, your yeast infection should conclude as usual, Dr. Shirazian says.

Normally, when you notice the first signs of a yeast infection, youre probably tempted to run to the drug store, pick up an antifungal suppository, and call it a day. But you should consider at least calling your ob/gyn before trying to treat the infection at home, especially given our current reality.

Continued here:
How to Manage a Yeast Infection and Period Symptoms at the Same Time - Self

The Latest Growth Report on Endometriosis Therapies Market size | Industry Segment by Applications (Hospital,Clinic andOther), by Type (Hormonal Contraceptives,Gonadotropin-releasing Hormone (Gn-RH) Agonists ,Progestin Therapy andAromatase Inhibitors), Regional Outlook, Industry Demand, Latest Trends, Endometriosis Therapies Industry Share, Research Growth Forecast & Revenue by Manufacturers, The Leading Company Profiles, Growth Forecasts 2026.

The Endometriosis Therapies market study offers a thorough examination of the industry space primarily by evaluating the major parameters that define the market dynamics production and consumption. In term of production, the report incorporates information pertaining the product manufacturing, its revenue, along with gross margins of the manufacturers. The unit costs offered by the producers across various geographies are also provided in the report.

Request Sample Copy of this Report @ https://www.aeresearch.net/request-sample/185076

With respect to the consumption facet, the research report details the product consumption share and volume while listing out the individual sale prices. It also lays out the import and export graphs across various geographies and concludes by predicting the production and consumption patterns of the Endometriosis Therapies market during over the projection period.

A brief outline of the regional outlook:

A gist of the product spectrum:

An outline of the application spectrum:

Brief summary of the competitive landscape:

To sum it up, assessment on the upstream raw materials, downstream buyers, and distribution channels has been documented in the Endometriosis Therapies market report.

Table of Contents:

Executive Summary: It includes key trends of the Endometriosis Therapies market related to products, applications, and other crucial factors. It also provides analysis of the competitive landscape and CAGR and market size of the Endometriosis Therapies market based on production and revenue.

Production and Consumption by Region: It covers all regional markets to which the research study relates. Prices and key players in addition to production and consumption in each regional market are discussed.

Key Players: Here, the report throws light on financial ratios, pricing structure, production cost, gross profit, sales volume, revenue, and gross margin of leading and prominent companies competing in the Endometriosis Therapies market.

Market Segments: This part of the report discusses about product type and application segments of the Endometriosis Therapies market based on market share, CAGR, market size, and various other factors.

Research Methodology: This section discusses about the research methodology and approach used to prepare the report. It covers data triangulation, market breakdown, market size estimation, and research design and/or programs.

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Endometriosis Therapies Market Growth Is Skyrocketing Beyond Predictions - News by aeresearch

With his narrow face, prominent teeth and large eyes, Joey Hoofdman always looked very different from his siblings.

As well as that, his strong work ethic and keen sense of order was greatly at odds with the rest of his chaotic family.

Feeling like such an outsider made Joey miserable throughout his life. But when he began digging around for answers about his identity, little did he anticipate the scale of the genetic and ethical minefield he was about to step into.

While he was growing up in Rotterdam, Holland, Joeys parents never hid the fact they had needed help conceiving him. His dad who already had two kids from a previous marriage had gone through a vasectomy reversal for Joeys mum.

They told me they went to a doctor because of my father, explains Joey, 33. They undid the procedure because my mum really wanted to have children of their own.

Joeys parents insisted the fertility treatment theyd received had been straightforward his mother had been artificially inseminated with his fathers sperm. But Joey was unconvinced by this explanation: I was just so different from my brother and sister.

While Joeys father drank, argued, and was constantly in debt selling the kids belongings for cash, Joey by contrast was sensible, calm and early on began saving for a better life.

Eventually, sick of feeling so isolated, at just 15 Joey met his first boyfriend, moved in with him, and left his family home for ever. It was the best decision I ever made, he admits.

By the time Joey was 19, he was a successful gym owner and in a stable, loving relationship. But even though hed been able to escape the chaos of his family home, he was dogged with unease about his identity.

It nagged away at him until his father died in 2012 and believing hed never get to the bottom of it Joeys mental health spiralled.

Close friends saw it was really bothering me. It became a depression when my father passed away. I thought it was grief, but it never stopped. I felt, Maybe Im never going to know what happened?

'After three or four years, I was still in a state of depression and I didnt want to get out of bed. It was the worst feeling Id ever had.

When Joey considered suicide, his psychiatrist urged him to confront his mother. So, in March 2017, after making her a coffee and sitting her in the garden, Joey begged her for answers.

Is my father my biological father? Did something happen to you? Or am I from a neighbour or somebody else? Mum was quite upset when I asked her that. She couldnt believe I thought she might have been with another man. It distressed her, me thinking she had been unfaithful, but I just said, Mum, please. I have to know for sure.

Joey asked her to take him through exactly how he was conceived, and she said shed seen the vials of sperm labelled with the name of Joeys father.

When pressed on the name of the clinic and doctor, his mums patchy recollections led Joey to do an online search, which brought up a suburban clinic near where he grew up and the doctor Jan Karbaat.

Joey was shocked to see many complaints about missing paperwork and lost vials, suspicions that women had been given the wrong sperm, and also a court case. The government had shut the clinic in 2009. It was a horror story. Joeys mother was so upset by these findings, she threw her son out of the house there and then.

Continuing to Google Jan Karbaat sitting in his car, Joey spotted a photo of the fertility doctor behind the scandal, and got goosebumps, certain he was looking at his biological father.

It was like an electric shock. I couldnt see his face, only myself. I had the same smile, the same eyes. I sent the picture to friends, they said, Is that you, Joey?

Desperate for answers, Joey tracked down Karbaat, who was living locally. But when he knocked on his door, he was told the doctor, then 89, was too sick for visitors. A week later, he died.

Robbed of the opportunity to confront him, Joey searched for answers elsewhere. He discovered a Facebook group whose members suspected they were all Karbaats children.

Joey quickly built a rapport with Moniek Wassenaar, and noticed her Amsterdam home was strikingly similar in taste to his own. We decided to see if we were really related and did a test we were indeed half-siblings. That was the first match. It was very emotional.

Then, in June 2017, Joey put his results on a genealogy site that matches DNA results with others around the world. It paired him with Inge Herlaar, 39, who he rang, saying, I think Im your half-brother. Then came a match with Marsha Elvers, 38, another half-sister.

At the time of Karbaats death in 2017, he was thought to have had 22 recognised children from several marriages, and was suspected of secretly fathering 49 more with his patients without their permission.

In early 2019 a court decision was ruled allowing Karbaats DNA to be released for testing. Receiving the confirmation he was Karbaats son was momentous for Joey. When I saw it written down, I broke, he admits. It was almost too much to process.

Joey has at least 61 known siblings and the family keeps growing. With dark humour theyve called themselves the Karbastards. Now, Im no longer angry but I am curious, says Joey. I have the puzzle in my head, but I cant put the pieces together.

Maybe he did it because of the money, maybe he had a God complex. Thats what everyone says. But I think, at the start, he just wanted to help mothers have children.

Last month, Joey visited Karbaats grave in Rotterdam. It was the closest I could get to him. That was the most important thing so I could have peace of mind. Im not responsible for his wrongdoings and his actions, but I need to forgive him to move on. I deserve that.

Shockingly, Jan Karbaat is not the only doctor to have committed fertility fraud but no fertility doctor has ever been put behind bars for using their own sperm.

Donald Cline

In May 2015 it emerged that physician Donald Cline, whod featured in People magazine, had used his own sperm in the 1970s and 1980s while treating women in Indianapolis.

Cline was exposed after one of the people conceived at his clinic took a 23andMe DNA test, only to discover several unexpected half-siblings, whose mothers had all been Clines patients.

Norman Barwin

A pillar of the Jewish community in Ottawa, Barwin was head of the Canadian Fertility Society and had received the Queens Golden Jubilee Medal. Like Karbaat, he was first accused of chaotic record keeping, which led to women being given the wrong sperm.

But in 2016 it emerged hed been using his own sperm. Hes currently being sued by a group of his biological children, and their legal mothers and fathers, his former patients.

Cecil Jacobson

This twisted doc nicknamed The Sperminator by a TV doc about him fathered over 70 children in Virginia. His case inspired a 1993 book, Babymaker.

He also injected women with the pregnancy hormone HCG, so they produced symptoms and believed themselves pregnant.

He would give them ultrasounds and tell them that bowels or faecal matter were foetuses, before later telling them their baby had died.

The Immaculate Deception podcast is available weekly on Apple, Spotify and all podcast providers

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Doctor secretly fathered at least 60 children with patients without their permission - Mirror Online

If youre looking for a natural way to increase your energy and feel younger, you may be curious about Human Growth Hormone. While its sometimes painted in a negative light, due to its abuse by athletes and bodybuilders, when used properly, growth hormone replacement therapy is a safe and scientific way to regain energy and improve your overall quality of life.

What is Human Growth Hormone?

Human Growth Hormone (or HGH) is a protein that is secreted in spurts by thepituitary gland. HGH is secreted after exercise, trauma and right before falling asleep. Under normal conditions, levels alternate throughout the day, with the highest amount appearing at night. Human Growth Hormone secretion rises during childhood, peaks at puberty and starts to decline in middle age.

What Does Human Growth Hormone Do?

HGH is responsible for promoting vertical growth in kids and teens, as well as a few key metabolic responsibilities throughout adulthood.

Functions include: stimulating the growth of bone and cartilage raising the production of protein in the body utilizing fat and regulating blood sugar

Our bodies natural production of this vital hormone starts to declines in our thirties.The results can lead to:

But isnt this just a normal part of aging? Dont we simply have to embrace that, as we get older, we are going to put on a few pounds and need to double our espresso order? Not necessarily.

Replacement Therapy is a safe, medically supervised treatment for growth hormone deficiency in adults. Studies have proven that the replacement of growth hormone can lead to: increased lean muscle mass decreased fat mass

Where Can I Access Hormone Replacement Therapy?

The following clinics in Florida are certified in the administration of hormone replacement therapy:

With locations in Jacksonville, Miami, Orlando, Tampa and West Palm Beach, Ehormones MD offers a convenient way to explore hormone replacement therapy. They have a team of medical doctors who will design a unique protocol for you based on your lab work. Medications and supplies are shipped directly to your home. You can administer the hormones by yourself via a small needle into your lower belly every night, before bed. Follow-up lab work is scheduled five to eight weeks following the start of treatment, with additional labs every six months thereafter. Additional services include fitness programs, nutrition plans, stress reduction plans and ongoing evaluations.

Health Gains clinics are located in Aventura and Madeira Beach, Florida. The clinics offer white-glove concierge service with no waiting. Their highly trained medical team includes doctors, nurse practitioners and bi-lingual medical assistants. The latest technology is combined with a spa-like environment to help patients overcome the symptoms of aging and improve their quality of life. Services also include Peptide Therapy, Thyroid Hormone Therapy and Testosterone Therapy for men.

Located in Miami,HGH Therapy Clinicwas founded in 2009 as a free information center for endocrine problems. Since then, it has evolved into state-of-the-art facility featuring the best and newest technologies of hormone treatment. Their team of doctors includes specialists in endocrinology, diabetes, metabolism and internal medicine. They specialize in Growth Hormone Deficiency Treatment for both men and women.

The goal of the Rejuvenation Clinic is to promote vitality through the early detection of hormonal imbalances. Their patient advocate support team will empower you to understand your treatment from start to finish. The process starts by filling out a confidential medical history form online. Within minutes, you will be assigned to a wellness advisor who will help you to set up a physical exam and a lab test. Additional treatments include Testosterone Therapy, Intracavernous Injection Therapy (ICI), supplements and amino acids.

AtTampa Rejuvenation, a team of doctors and nurse practitioners are there to help you achieve optimal health through weight loss and bioidentical hormone replacement therapy. With three convenient locations in Tampa and one in Brandon, FL, accessing the treatment you need is easy. Services include hormone therapy for both men and women, as well as treatments for adrenal fatigue, thyroid issues and hair restoration.

Go here to read the rest:
HGH Replacement Clinics of Florida: Choose Only the Best - South Florida Reporter

According to The International Dermal Institute, 55% of women over 25 have adult acne. And chin acne lets call it ch-acne is the second most common kind of adult acne (67%) falling shortly behind cheek acne (81%). But why do spots congregate in this relatively small area of the face? Weve spoken to Dr Nick Lowe, Consultant Dermatologist at The Cranley Clinic and co-author of Perfectly Clear, to find out why the chin has become a sebum battleground.

Acne tends to occur more in areas with a lot of oil-producing glands, AKA sebaceous glands, explains Lowe. Pores can become blocked by excess oil from the glands, and acne bacteria builds up below the skin, producing inflamed spots. One of the highest concentrations of these glands is, you guessed it, around your chin area.

But theres more to it. For starters, particular irritants specific to the chin can cause breakouts that look just like, but actually arent, acne (more on this later). Also, as much as we all hate to admit this, it looks like those old wives tales were right factors like touching your face, as well as eating sugary food, play a big part too.

Read on to discover the main causes of chin acne, or ch-acne, and how to tackle it.

Acne is caused when a pesky group of hormones caused androgens are released often as a response to your contraception. This type of acne is characterised by smaller inflamed spots around the mouth and chin although you can also get larger, cystic acne spots on the chin too.

Sound familiar? 'It tends to be contraceptives with high progesterone compared to oestrogen that aggravates acne,' says Nick. So if youre on something like the progesterone mini-pill or the hormonal implant (which releases progestogen, a hormone similar to progesterone) and youre getting acne flare-ups around your chin and mouth then, well, it adds up. Instead, you could switch to a low progesterone contraceptive pill that actually helps your skin, like Yasmin.

Your chin also acts as a landing pad for your toothpaste, which, it turns out, is chock-a-block with irritants especially one ubiquitous ingredient: fluoride. This condition, where acne-like symptoms occur around the mouth and chin area, looks like acne, but its actually peri-oral dermatitis, explains Nick.

A secondary culprit is sodium lauryl sulphate (SLS), which is present in toothpaste brands as well as many other cosmetics such as shampoo. However, this will only irritate skin, rather than single-handedly cause something which resembles acne, explains Nick.

While we're not suggesting for a minute you ditch toothpaste in the name of good skin, there are some great irritant-free toothpastes that do the job just as well as your go-to brand. Try JASONs brilliant range of SLS-free, fluoride-free toothpastes.

Sadly, when tackling acne, your diet could be the cause. There are two main food culprits to avoid if you get chin acne, according to Nick. First off, its high GI foods like chocolate, white bread and sugary breakfast cereals (check the sugar content of your granola). The body produces insulin-like hormones to deal with the high amount of carbohydrate youre absorbing in the bowel, and for some those hormones cause acne.

Milk can also be a trigger. In people susceptible to acne, drinking milk including skimmed can make the condition worse, because it contains androgenic hormones. Nick recommends swapping to soy or almond milk over a six to eight-week trial. It takes that long to see an improvement. The good news is, yoghurt doesnt seem to have the same effect, thanks to the fermenting process removing some of the hormones; so your mid-morning Fage habit is safe.

Yes, you're mobile phone can cause spots...and anything else coming into contact with your chinny chin chin, basically. If you rest your chin on your hands or phone, the friction can block the pores, causing acne bacteria to build up, says Nick. Same story if you wear a cycling helmet with a chin strap. If you have existing acne, friction aggravates the inflamed spots so snogging your stubbly boyfriend wont help either.

As for me, my acne struggle had a happy ending. A course of antibiotics (to kill the acne bacteria) and a new contraception pill (Yasmin, my old friend) got rid of most of it. Then, just three months ago, the last nail in the coffin was changing my toothpaste who knew fluoride was the cause of my remaining acne-that-isnt-actually-acne?

For those still battling acne, on the chin or otherwise and believe me, I know how crap it is Nicks advice is to stick with finding a solution: If you have acne that is continuing, look at all your habits: your toothpaste, your diet and your contraception. Start off with topical medicine, then look into these other factors and find what works for you.

Shop the best products for acne-prone skin:

Apply a thin layer of this serum meets moisturiser all over the affected area and let the five acids (including Salicylic and Glycolic acid) get to work to minimise the appearance of spots.

Keep this handy stick in your handbag and apply it at the first sign of a spot - so, whenever that sore, swollen bump appears. Formulated with 2% salicylic acid to exfoliate the skin and tea-tree oil to calm the area - you'll notice the benefits in no time.

It might sound counter intuitive to add more oil to oily skin but it can in fact help to balance the skin's mantle. This blemish oil calms irritated skin, helps to heal spots and will also treat scars.

La Roche-Posay's anti-blemish cream is formulated to target oily, blemish-prone skin. It has become a cult product for beauty buffs who have raved about its magical ability to unclog pores, minimise imperfections and give the surface of the skin a smooth velvety finish.

The Body Shop's Tea Tree Oil range is proven to contain healing and antibacterial properties for every type of skin. The Body Shop claim that the range can create clearer skin in 3-days without over-stripping the skin. We love the Tea Tree Squeaky Clean Scrub (with biodegradable micro-beads) and Tea Tree Night Lotion to combat shine and impurities day and night.

This highly coveted skin elixir is not only surprisingly affordable but also promises to refresh and repair your complexion by clearing up and soothing whiteheads overnight. All Mario Badescu asks is that you dip a cotton swab into the pink sediment, dab on a pimple and wash off in the morning. Do not shake the bottle.

Enriched with cocoa butter, rosemary, eucalyptus and chamomile this indulgent cream cleanses, soothes and moisturises. Used alongside Liz Earle's pure cotton cloth, dead skin cells and daily grime are lifted away to reveal brighter looking skin.

Aesop is fast becoming the favorite beauty brand of the year because of the visible results. The parsley seed extract cleanses deep within the pores - exactly what you need for troublesome skin. Frequent use of this product will prevent future breakouts, and using this overnight won't leave you feeling oily or clogged up the next morning.

Dermalogica's Clay Cleanser treats spots when used as a wash and as a face mask. It concentrates on the affected area and uses refreshing cucumber to leave you feeling rejuvenated.

The most common places for acne and spots, particularly in the winter months, are your cheeks and jawline. To prevent this your skin must be well moisturized, and this Origins product is enriched with boosting ingredients to brighten your complexion. And it's completely oil-free.

Apply this serum onto your acne scars or discolouration after you've washed your face and before you moisturise, and overtime it will even your complexion.

READ MORE: Breakout Breakdown: What Is Actually Causing Your Spots?

READ MORE: Everything You Need To Know About Pimple Patches Do They Really Keep Spots At Bay?

View post:
What Causes Chin Acne And How Should You Treat It? - Grazia

MILPITAS May 9, 2020 (Thomson StreetEvents) -- Edited Transcript of Protagonist Therapeutics Inc earnings conference call or presentation Thursday, May 7, 2020 at 9:00:00pm GMT

* Dinesh V. Patel

Protagonist Therapeutics, Inc. - CEO, President, Interim PAO, Secretary & Director

* Donald A. Kalkofen

Protagonist Therapeutics, Inc. - CFO

* Samuel R. Saks

Protagonist Therapeutics, Inc. - Chief Medical Officer

* Christopher N. Marai

Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology

SVB Leerink LLC, Research Division - MD of Rare Diseases & Senior Research Analyst

Good day, and welcome to the Protagonist Therapeutics PTG-300 Development Update Call. Please note that today's conference is being recorded. At this time, I would like to introduce Don Kalkofen, Protagonist's Chief Financial Officer. Please go ahead.

Donald A. Kalkofen, Protagonist Therapeutics, Inc. - CFO [2]

Thank you, operator. Good afternoon, everyone. Please note that a replay of today's call will be available at the Investors section of our website at protagonist-inc.com.

Before we begin, I'd like to remind you that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our quarterly and annual reports on forms 10-Q and 10-K, which are on file with the SEC. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our view should change.

With that, I will now turn the call over to Dinesh Patel, President and CEO, to provide you an update on the company's progress to date.

Dinesh V. Patel, Protagonist Therapeutics, Inc. - CEO, President, Interim PAO, Secretary & Director [3]

Thanks, Don. Good afternoon, everyone, and thank you all for joining us today. On today's call, we'll also hear from Samuel Saks, our Chief Medical Officer; and Dr. Ronald Hoffman, Professor of Medicine in Hematology and Medical Oncology at the Mount Sinai Hospital in New York City. Dr. Hoffman has been involved in the Phase II clinical study of PTG-300 in polycythemia vera, and he will provide a brief overview of the disease and his perspectives on PTG-300 and its potential benefits as the novel treatment for polycythemia vera or PV.

Also present for the call today are David Liu, our Chief Scientific Officer and Head of R&D; and Suneel Gupta, our Chief Development Officer. We are pleased to have all these individuals available to address questions during the Q&A session of today's call.

So let's start with Slide #3. As you are well aware, Protagonist started the year 2020 with 3 clinical assets, all of which have been discovered through the use of our peptide technology platform in 6 different clinical proof-of-concept studies. The 3 assets fall in 2 broad categories: PTG-300 for various blood disorders, most of which are rare disease; and oral GI-restricted targeted peptide PTG-200 and PN-943 for inflammatory bowel disease, or IBD. All of these assets have a multibillion-dollar potential in multiple indications.

PTG-300 peptide mimetic of the natural hormone hepcidin that serves as a master regulator of iron homeostasis storage and distribution in the body was being pursued in Phase II open-label proof-of-concept studies in beta-thalassemia, or beta-thal; polycythemia vera, or PV; hereditary hemochromatosis, or HH; and an investigator-sponsored study in myelodysplastic syndrome, or MDS. As you may recall, a major objective for 2020 was to pick our first clinical indication for PTG-300 that we can progress towards a pivotal study in 2021.

Today, we are pleased to announce initial but yet very robust clinical data from our polycythemia vera program. And the selection and prioritization of polycythemia vera as the first indication for a pivotal study with 300. This decision is based on 3 criteria: strength and consistency of the clinical data, favorable regulatory path forward and the commercial opportunity. This is our major announcement today. And while most of our discussion will be around 300 and polycythemia vera, let me also take this opportunity to talk briefly about our oral gut-restricted IBD assets, largely in the context of corporate update and cash runway.

The enrollment rate of Phase II studies of these agents, namely the oral alpha-4-beta-7 integrin antagonist PN-943 for ulcerative colitis and the oral interleukin-23 receptor antagonist PTG-200 for Crohn's disease are understandably going to be influenced by the current COVID-19 situation. Therefore, while these studies are continuing, we believe it is appropriate to remove future guidance on the timelines for top line data from these studies.

In addition to the decision to focus our efforts towards rapidly advancing 300 in polycythemia vera indication, we are continuing the ongoing proof-of-concept study of 300 in hereditary hemochromatosis as a potential second indication and are also deciding to now discontinue further development of 300 for beta-thalassemia as well as for myelodysplastic syndrome.

On the financial side, we ended the first quarter of this year with about $117 million in cash and investments. By factoring in the delay in enrollment and the associated clinical development costs, coupled with a reduction in operational needs and expenditures, we are now extending our cash runway by an additional 6 months through the middle of 2022.

Now let's go to Slide #4, and let me turn to PTG-300, a major highlight of today's call and to provide rationale for why we are pursuing polycythemia vera as our first indication. First and foremost, it's the robust and consistent clinical responses we have seen in our ongoing Phase II PV trial. Although small, the data set is very compelling and consistent. On 6 out of 6, dose compliant patients treated for up to 28 weeks with 300 are phlebotomy free as of today. These are very noteworthy results. Keeping in mind that prior to entering our study, these subjects were receiving frequent phlebotomies in the weeks leading up to enrollment. We are obviously very encouraged by these results, and the enrollment in the study continues with 8 patients enrolled to date. And we have also decided to now expand the current study from 30 patients to 50 patients.

The second factor is the regulatory path forward for the development of 300 in polycythemia vera indication. As you know, approved drugs for polycythemia vera fall into the orphan drug designation category by virtue of it being a rare disease in the U.S. and Europe. And orphan status provide certain benefits to the drug developer, including 7 years of market exclusivity upon FDA approval, prescription drug use of fee waivers and tax credits for qualified clinical trial.

The third factor besides the data and the regulatory path is the very significant commercial opportunity that lies ahead of us based on the significant unmet need that exists today for these patients. And specifically, by virtue of PTG-300 being a novel mechanism-based, first-in-class non-cytoreductive natural hormone mimetic agent. While PV is a rare disease, there are approximately 100,000 people in the U.S. living with this disease, and this number is unfortunately expected to grow as the population ages. The majority of PV patients are treated with phlebotomies, cytoreductive therapies or a combination of those treatments.

Jakafi is the only FDA-approved cytoreductive therapy in PV and despite having a limited indication in patients who have had an inadequate response to current treatment, Jakafi is expected to reach almost $2 billion in sales in 2020, and the largest percentage growth is in the PV population, 19% year-over-year based on their most recently quarterly update. PTG-300 has the potential to address a significant unmet need in this category where there is a lack of new cytoreductive agents in development. 300 offers the potential of keeping patients phlebotomy-free without causing iron deficiency.

So to summarize, we are incredibly encouraged by our preliminary but strong and consistent data and, therefore, are electing to focus our resources on expedited development of 300 for polycythemia vera.

To speak more about this, I would now like to introduce our Chief Medical Officer, Dr. Samuel Saks. Sam?

--------------------------------------------------------------------------------

Samuel R. Saks, Protagonist Therapeutics, Inc. - Chief Medical Officer [4]

--------------------------------------------------------------------------------

Thanks, Dinesh. As Dinesh mentioned, we are really encouraged by the results we have seen in the ongoing Phase II study of PTG-300 in patients with polycythemia vera. Dr. Hoffman is going to walk you through the study results in detail, but I wanted to highlight why I believe this data has prompted us to focus on PV as the first indication for 300.

The majority of PV patients today are treated with phlebotomy, or phlebotomy in combination with cytoreductive therapies to control erythrocytosis and keep the hematocrit levels below 45%, as indicated in many treatment guidelines. There is a large body of evidence that shows that managing hematocrit is challenging and regardless of best available therapy, they're a substantial portion of patient segments that have poorly controlled hematocrit and therefore, a higher mortality rate compared to age match controls. The treatment paradigm of PV allows patients to enter what I call the danger zone before they get the next treatment. So even those people who are considered well-controlled have increased hematocrit leading up to their phlebotomy. Self-administered 300 may reduce doctor visits and the anxiety associated with the uncertainty of phlebotomy at that time. Phlebotomy is those of donated blood know, is associated with acute symptoms and difficulties. But the real problem in these patients is the potential for chronic symptoms related to iron deficiency in phlebotomized patients.

PTG-300 offers the possibility of putting the control of the hematocrit in the patient's hands with a weekly self-injected mimetic of an endogenous hormone mimetic. With a clear decision to focus PTG-300 development in PV, we are expanding the current study to include additional patients, and we'll be also hosting a scientific planning meeting with leaders in the field of myeloproliferative neoplasms. We will also be working with patient advocates to discuss pivotal and future studies in polycythemia vera.

I will close by saying that while further follow-up and data from additional patients will be needed to confirm the continuity of the robust clinical responses observed to date, we believe this study provides a compelling rationale to initiate planning for a pivotal program in PV. In the near term, we are expanding the current study to include additional patients as we focus on these encouraging results.

Finally, I want to express how proud I am of the entire clinical development team of Protagonist and all the Protagonist employees that helped us to get where we are today with this program.

With that, I would like to turn it over to Dr. Hoffman, who needs no introduction. He's a recognized expert in the field of myeloproliferative disorders and is Director of the Myeloproliferative Disease Program at The Icahn School of Medicine at Mount Sinai and an investigator in the 300 study. Dr. Hoffman?

--------------------------------------------------------------------------------

Ronald Hoffman, [5]

--------------------------------------------------------------------------------

Yes. Thank you very much, Sam. Thanks for the opportunity to present this really exciting data. So if we can go to Slide 7, I can educate the audience on what polycythemia vera is so they can have a better understanding of the potential for 300 and put this in context.

So as you can see here, this slide is entitled "What is Polycythemia Vera?" Well, polycythemia vera is a member of a group of chronic hematologic malignancies termed myeloproliferative neoplasms. And these neoplasms are unusual in that patients frequently live several decades. And these neoplasms occur at the level of the hematopoietic stem cell. And unlike leukemia, they are characterized by increased production of mature blood cells. In polycythemia vera, the cell that's most destructive to the patients are really the increased production of red blood cells. And that's the term erythrocytosis that you've heard previously and we'll hear subsequently.

Now the interesting thing about this disease is that there are 100,000 cases of polycythemia vera in the United States. This disease occurs across races and age groups. And the critical diagnostic warning sign is that of an elevated hematocrit, which is the hallmark of the disease. I think the importance of this drug is that although there's 100,000 cases of these patients, these patients, as I mentioned, live for several decades, so the usage of this drug would be quite prolonged over that period of time.

The disease occurs primarily in individuals who are 50 to 70 years of age. There is, however, a higher incidence in young females who present with life-threatening thrombotic events. The thrombotic events that occur in patients with polycythemia vera include strokes, as well as life-threatening thrombosis of arteries or veins within the venus -- within the abdominal cavity. There's a very high incidence of acute myocardial infarction, cerebral vascular incidents and strokes. The women that we've talked about, the young women, they are particularly prone to develop thrombosis within the abdominal cavity, especially the hepatic vein, and that leads to a life-threatening condition called Budd-Chiari syndrome. In its most severe forms, it requires liver transplantation.

Over the last 15 years, there's been tremendous understanding -- new understanding of this group of myeloproliferative neoplasms. And they've been shown to be characterized by mutations in genes that are associated with myeloid blood cell production. So the myeloproliferative neoplasms are associated with 3 driver mutations: one involving JAK2, the other gene called calreticulin and the other MPL, which is a receptor for the hormone thrombopoietin. Virtually 99% of patients with polycythemia vera have a mutation in JAK2. Most commonly, it is a mutation that occurs at exon 14, which is the JAK2V617F mutation. A smaller group of patients have a mutation in exon 12, and those are referred to as exon 12 patients, and they have a similar phenotype, again, elevated hematocrits, increased thrombosis and shorter lifespan due to these thrombotic events and severe erythrocytosis.

Next slide, please. We're going to talk now about the diagnosis, symptoms and treatment of polycythemia vera, so that you can get an understanding of the role of -- the potential role of PTG-300. The diagnosis of polycythemia vera is triggered by finding an elevated hematocrit serendipitously or by a thrombotic event, and that initiates the physician looking for the diagnosis. So for instance, a patient could present within an acute myocardial infarction and be found to have hematocrit. These warning signs, then prompt, the blood tests to be performed that look for the presence of the JAK2V617F mutation or the exon 12 mutation of JAK2V617F is not present. And sometimes, a bone marrow examination is required to perform histopathologic confirmation of the diagnosis.

This disease is not only complicated by thrombotic episodes, but it's also complicated by burdensome systemic symptoms, including fatigue, headache, visual symptoms, night sweats and itchiness. And this itchiness characteristically occurs on exposure to water and has termed aquagenic pruritus. This might seem like a trivial symptom but aquagenic pruritus can be so severe that patients are unable to shower for months or can lead to such stress that occasionally, we've unfortunately had patients who have succumbed to suicide. Thrombotic events is the greatest risk to patients with polycythemia vera. These thrombotic events, as I mentioned, include heart attacks, strokes, deep vein thrombosis or pulmonary embolism or the Budd-Chiari syndrome. The cardinal feature of treatment and reduction of this thrombotic risk is to reduce the hematocrit below 45%. Again, the hematocrit is just the measure that we use of the number of red blood cells and the degree of erythrocytosis. And that assures that essentially the viscosity of the blood or the stickiness of the book is reduced, thereby reducing the incidence of thrombosis.

So normalization of the hematocrit using therapeutic phlebotomy is very common, and it is really the first treatment in newly diagnosed patients with polycythemia vera. Unfortunately, therapeutic phlebotomy leads to the removal of red blood cells, which contain iron and it leads to more severe iron deficiency contributing to many of the exacerbation, of many of the systemic symptoms that I referred to previously. And those patients that require frequent phlebotomies or at their advanced stage that is over 60 years of age or have thrombosis, a prior thrombosis, it is the recommendation of the standard of care that those patients all be treated with hydroxyurea, interferon or Jakafi. It is in this situation that 300 is especially attractive drug because it can be used to treat patients who are not requiring myelosuppressive agents or it could be a replacement for those myelosuppressive agents. Again, the site of the reductive agents are hydroxy and interferon, which are used in combination with phlebotomy, with supplemental phlebotomy, or an alternative drug is Jakafi or ruxolitinib, which is the only U.S. FDA-approved product for phlebotomy. Each of these drugs, and I can go into that in detail during the question-and-answer period are associated with significant adverse effects and have a question -- and have a questionable surrounding their tolerability. Significant evidence, as I've mentioned, shows that controlling the hematocrit below 45% is the most important factor in minimizing thrombosis, cardiovascular events and death due to thrombosis.

Please let's go to the next slide. So we're going to talk a little bit about phlebotomy, which many of you have probably experienced when you donate blood. So most patients receive phlebotomy initially. Phlebotomy is basically the removal of a unit of blood to reduce the hematocrit below 45%. So our target is to keep those patients always below 45% because it's been well demonstrated in the literature that, that reduces significantly the incidence of thrombosis. And the incidence of thrombosis has been shown to be reduced when the degree of time with an adequate of 45% is maximized. In addition, these would patients receive low-dose aspirin to paralyze their platelets and their -- or further augment this antithrombogenesis in patients with polycythemia vera. Patients who undergo phlebotomies will often report feeling tired or dizzy after the phlebotomy. And especially in the elderly, this is a major factor. Many of these patients become hypertensive, require long stays in our outpatient facility or require fluid infusions because -- or going to congestive heart failure because of their poor fluid balance. Furthermore, regular phlebotomy results in iron deficiency that makes -- the augmentation of iron deficiency that may have a debilitating -- that may have debilitating symptoms. As I mentioned, particularly severe fatigue, weakness and cognitive impairments. This cognitive impairment is a really big deal because many of the patients complain of having a fuzzy brain syndrome, and they cannot concentrate and do their jobs. In addition, some of the patients have craving for unusual substances such as ice or clay, which is termed pica. And then, unfortunately, some of the patients have a restless leg syndrome, which prevents them from going to sleep. Three or more phlebotomies in a year in those patients receiving hydroxyurea is associated with an inferior prognosis and a higher incidence of thrombotic events. So you can also think that in those -- in that situation, even in a patient who is receiving hydroxyurea, their combination therapy with 300 could eliminate those frequent phlebotomies and further improve the treatment regimen for these patients.

I think the most important part that you'll see about this drug are the real high-quality aspect of it is that we see these patients, let's say, a 3- or 4-month intervals. At that 3- or 4-month interval, we see that they have an elevated amount of hematocrit and that triggers us to do a phlebotomy. But in reality, we have no way to monitor them during the interval between their visits, and it's likely that for significant periods of time, they have an elevated hematocrit that's only detected at the time of their visit to our clinic. So as you'll see, the really cool part about PTG-300 is that there's a sustained hematocrit control, which we've really never been able to achieve with any of the other agents or but -- or with phlebotomy alone.

Let's go now on to Slide #10, which is PTG-300 and non-cytoreductive hepcidin hormone mimetic, its mechanism of action. So how does this drug really work? Well, hepcidin hormone, has been established recently in the last couple of decades, is playing a primary role in promoting the sequestration of iron and macrophages and decreasing iron availability for the production of red blood cells. So macrophages are a type of white blood cell, and they are present not only in the bone marrow, but they're also present in all other body tissues. But the macrophages in the marrow are termed nursing cells because their activity is essentially to feed iron to red blood cells in the marrow and to alter -- to allow them to produce additional red cells. This process is disregulated by the JAK2 mutation leading to erythrocytosis. So PTG-300 is believed to limit the excess production red cells in polycythemia vera by essentially allowing that iron to remain in the macrophages. Therefore, preventing its transfer into the erythroid precursors. In addition, it blocks the iron that's present in the macrophages in the tissues outside of the marrow. And therefore, we believe alleviates many of the systemic symptoms that are associated with polycythemia vera.

Let's now go on to Slide 11, which is the Phase II study design. This is a really interesting manner in which this study has been constructed. You can see there are 3 phases. Part one is the dose-finding period, which is over 28 days. And there are 2 components to that. I believe a dose -- effective dose-finding phase, where we essentially dose-escalate patients to meet the inadequate requirements. Then a 12- to 14-week period where we essentially have efficacy evaluation that is to maintain the patient's hematocrit below 45%. And then there's part 2 as a blinded withdrawal where the patients are randomized to receive either the fixed active dose or placebo dose for up to 12 weeks. And then I'm sure the patients will be happy about that, those that go on placebo, they will then allow them -- we will be allowed to put them on to an open-label extension phase up to 52 weeks where they will again be able to receive 300. If the patient's hematocrits exceed 45%, they get supplemental phlebotomies.

Let's go on to Slide #12. This is essentially the responses that we've seen in the 7 patients that have been described, that have been evaluated. The red triangles indicate the phlebotomies, and you can see a lot of them to the left of the solid line. And that's the 32 weeks prior to treatment. And you can see that each of these patients, and these were entry criteria, had at least 3 phlebotomies during that period. And then you can see this dotted line, and that's the time at which the doses -- the drug was started. And the first thing that strikes you is that there are a lot of red triangles to the left and only one red triangle to the right, and that's one of our patients who missed one dose due to the -- unfortunately, due to the pandemic. And the numbers indicate the doses that were administered over that period of time. So for instance, you can see in patient 150201, there was a dose escalation and then de-escalation, which I'll discuss on the subsequent slide. So this really -- this slide really summarizes and probably is our most important slide. And it basically shows that with the administration of this drug and careful titration that phlebotomy is almost virtually eliminated.

Next slide. Let's focus on 2 patients. One is the top patient, which is the blue line. And you can see that this patient -- this is the individual who missed the dose because of the COVID infection. And you can see that he was started at 10 milligrams, then went up to 20 milligrams. And on 20 milligrams, he had a hematocrit 47.5, he was unable to come in at that time because of the COVID infection. So we increased his dose to 40 milligrams, his hematocrit dropped, but it was still above 45. He came in, we phlebotomized him, and we've kept him now on 40 milligrams, and you would have seen on Wednesday, and he did not require a phlebotomy and his hematocrit was below 45.

If you look at the bottom patient who is in bright red, you can see that, that patient started at time 0 on 10, then was increased to 20 and then on week 7 was -- got 40 milligrams and then on week 12 got 80 milligrams. And you can see that, that led to a hematocrit dropping to 37.5. We cut our dose to 40 milligrams, and you can see that over that period of time, she has remained phlebotomy-free. We saw her on Wednesday, and she again remains below hematocrit of 45. So there's a dose adjustment that you can easily do. The drugs are being administered at home by the patients, giving them a lot of freedom and also empowering them to control their own disease.

If we go to Slide 14. This addresses how do we know that PTG-300 is really hitting its target. And what we're measuring here is serum ferritin. And if you can recall, ferritin is a molecule that reflects storage iron. And you can see these numbers in the vertical column, and if you're below 25, that indicates that one is iron-deficient. And you can see it with the administration of the drug at subsequent doses over time, the ferritin doses, the ferritin levels increased in each of these patients except the bottom line where a patient received an extremely hematocrit control with an extremely low dose of 300. So these data indicate that the drug is acting on target.

What about the adverse defense? Because this is a chronic disease, one must anticipate that patients will be treated over decades. This is a small sample set but you can see that we had no serious adverse events and the adverse events that were recorded were essentially just irritations, essentially at the injection site that slowly resolved and one of the patients had a bruise at a 10-milligram dose.

Let's go on now to Page 16, which is our summary. So just to start this off. I think phlebotomy is used -- has probably been used for almost 100 years. And for at least, since I've been in this field, which is from the 70s, there's been great debate about what is the optimal myelosuppressive agent. There's great concern about chemotherapy being used in these patients, perhaps increasing the incidence of evolution to acute myeloid leukemia. We never really anticipated that a hormone therapy might be used for this type of disease. So I think this really represents -- this trial really represents a paradigm shift and it has great importance for patients with polycythemia vera. So I think we can easily conclude that the additional data demonstrates the potential of this drug to almost entirely avoid the need for bottoming the treatment of polycythemia vera. All dose compliant patients were phlebotomy-free. Persistent control of hematocrit levels, I think that's really one of the most important issues is that the patients are -- have a sustained control of their hematocrit, which we anticipate will lead to sustained alleviation of their systemic symptoms and elimination of thrombotic episodes. And again, as I tried to indicate to you these elevated hematocrit levels are associated with significant cardiovascular events such as heart attack and stroke. This drug also offers the possibility of weekly administration without the up and down excursions inherent in phlebotomy therapy or any of the toxicities associated with phlebotomy therapy that I discussed with you.

Also, this reduction in phlebotomy may allow sufficient iron to be available systemically to avoid symptoms that we know that are related to iron deficiency. So PTG-300 has the potential as the first non-cytoreductive therapy for PV. This drug is well tolerated and has a safety profile similar with results in prior studies. So as you can see from my presentation, I'm extremely enthusiastic about this drug and its future. Thank you for your time.

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Dinesh V. Patel, Protagonist Therapeutics, Inc. - CEO, President, Interim PAO, Secretary & Director [6]

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Thank you, Dr. Hoffman. I would like to note that the results we have discussed today address the study data as of May 1, and the study continues to enroll. And our plan will be to submit to present additional data at upcoming medical meetings. So at Protagonist, we are now working on 4 clinical programs with our 3 candidates, all discovered through our technology platform.

Our priorities are: one, advancing PTG-300 in polycythemia vera as well as in hereditary hemochromatosis; two, advancing PN-943 to a Phase II study in ulcerative colitis; and three, working closely with our partner, Janssen, to continue Phase II development of PTG-200 in Crohn's disease. As a result of our ability to limit our focus with 300 to PV and HH, we have organized our efforts to extend our cash runway for an additional 6 months. We have taken steps to manage and lower our operating costs and align our resources around our current studies. As a consequence, we now have adequate financial resources to fund planned operating and capital expenditures through the middle of 2022.

Finally, we are mindful of the impact that the current coronavirus outbreak may have on our local operations and global activities. As we disclosed in our financial results released today, we are suspending guidance for PN-943 Phase II initiation and PTG-200 Phase II data, and we are actively working to minimize impact on timelines and move as quickly as conditions would permit. Our priority is maintaining the health and safety of our employees and those who are participating in our studies. We will continue to monitor changing conditions carefully and provide updates as appropriate.

With that, we would like to now open up the call for questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Chris from Nomura.

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Christopher N. Marai, Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology [2]

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This is Chris Marai from Nomura Instinet. Maybe the first one is for the physician on the line. Thank you so much for the overview of PV. I was curious how you look at a therapeutic like PTG-300 in terms of clinical practice on sort of an everyday basis as you see PV patients? And how do you think it may fit, assuming this profile remains consistent in sort of the treatment lines of PV, how you may see its usage, in particular relative to drugs like Jakafi?

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Ronald Hoffman, [3]

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Okay. I think that's a really terrific question. I think its use would be quite wise -- wide. I think virtually all patients with PV would be candidates for this drug. We've -- as you can see, we have treated young patients and also older patients with this drug. So it's been well tolerated. I think the advantage, again, is that, especially with young patients, those individuals, we do not want to give life-long myelosuppressive therapy or interferon or Jakafi because of unanticipated -- potential for unanticipated adverse effects. So if they have an increased phlebotomy requirement, this would be an ideal treatment for those folks because basically, it would free them up from returning to the clinic as frequently as they do and requiring repeated phlebotomies. When we risk-stratify these patients, those patients that go on the 3 treatments that I've discussed before, frequently, they still require phlebotomies, and it's been shown by European investigators, if you have additional phlebotomies during your administration of these drugs, that you are an increased risk of thrombosis. So in that setting, this drug could be an adjunctive agent that would eliminate the needs for phlebotomy.

Alternatively, and I could see this developing quite quickly, patients are frequently unwilling to take any of these agents, especially hydroxyurea and interferon because of the potential of hydroxyurea and the concern about interferon essentially having systemic symptoms, problems with individuals about immune disease and also its effect to exacerbate depression in patients. So in those individuals, I could see and even in those high-risk patients, if we can control their hematocrits with this drug, which I think we can easily do, and we've demonstrated that. That this drug would be a real competitor for any of those agents. So I think it could be essentially utilized potentially for the broad swath of patients with polycythemia vera. So I think -- and for long periods of time, that's the issue that I'd like to really emphasize to you. For instance, like young females who have Budd-Chiari syndrome, and we usually put those young females on myelosuppressive therapy and interferon for life-long periods of time, and they can live several decades. They would far prefer being on a non-chemotherapy, non-biologic agent like interferon, it would really liberate them, especially from the adverse effects.

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Christopher N. Marai, Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology [4]

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Okay. That's very helpful. And then I was wondering if we could touch upon the data for a minute. Dr. Hoffman, could you elaborate on some of the effects of spleen size that you may have observed in the trial, if any? What you would hope to see there on an endpoint like that in a patient population like this?

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Ronald Hoffman, [5]

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Yes. So in this situation, what you have to understand is this is not myelofibrosis. So in reality, most patients with -- or virtually all patients -- I'll say most, the overwhelming majority of patients with patients with polycythemia that don't have symptomatic splenomegaly. So the endpoints that have been used in the past, let's say, for Jakafi for reduction of spleen size are of minimal importance. So these patients, even though some of them have high-risk disease, really didn't have -- they had minimal splenomegaly at all, only 40% of patients with polycythemia vera have splenomegaly and only for our advanced disease it's symptomatic. So the sample size is too small. In animal models, when hepcidin mimetics were given, those are polycythemia vera animal models, the administration of a different hepcidin mimetic did lead to reduction in splenomegaly but we really were not able to assess this because none of these patients really had significant splenomegaly. So we await treating patients like that to see if the data in the mice is recapitulated in humans as it relates to spleen size.

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Christopher N. Marai, Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology [6]

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Very helpful.

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Operator [7]

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Our next question comes from the line of George Farmer of BMO.

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Read more:
Edited Transcript of PTGX earnings conference call or presentation 7-May-20 9:00pm GMT - Yahoo Finance

In 2018, the floor fell out beneath Protagonist Therapeutics. Months ahead of an expected readout, the companys first major trial, a Phase IIb testing their lead drug in ulcerative colitis, failed a futility analysis. Investors sold off en masse. Protagonist searched for answers.

Two years later, CEO Dinesh Patel maintains the drug had efficacy pointing to a blinded re-read conducted later that year but the company has moved on. Now, armed with the results from a small proof-of-concept, they are readying to put their resources behind a new lead program and another attempt at a pivotal trial in an entirely different disease.

We couldnt have asked for better data, Patel toldEndpoints News.

The drug is an artificial protein called PTG300. Unlike the drug in the 2018 trial or a compound licensed in 2017 to J&J, PTG-300 is designed to treat blood disorders. Since August, the company has been testing it in a series of tiny proof-of-concept trials to see how well it works in different diseases, including beta thalassemia, hereditary hemochromatosis and myelodysplastic syndromes.

The latest study, announced today, is in people with polycythemia vera, a chronic blood cancer in which patients produce an overabundance of red blood cells. Complications can range from itchiness to blood clots. Normally, patients are treated with phlebotomies every few weeks or months. The problem, though, is that their red blood cell counts can rise in-between and continually removing a persons blood is not without consequence. It can lead to weakness and iron deficiency, among other complications.

In the part of the trial that is now evaluable, investigators gave different doses of PTG-300 to 7 different patients who had at least three phlebotomies in the 24 weeks prior. Six patients did not need a phlebotomy over the 4 to 28 weeks they took it. A 7th had an unintended interruption to his dosing, received a single phlebotomy and continued therapy.

Lead investigator Ron Hoffman, called it a potential paradigm shift. Unlike phlebotomies or the other drugs used to treat the disease, it could allow patients to maintain good red blood cell counts over long stretches without severe side effects.

What has been done for 100 years is that patients undergo blood letting essentially, Hoffman told Endpoints. We didnt anticipate using this kind of approach. Its really pretty cool actually, Im excited.

The drug mimics the effect of hepcidin, a natural hormone that regulates iron levels. Because the body needs iron to produce red blood cells, limiting those levels can in theory limit overproduction in these patients.

The results convinced Protagonist to pick their lead indication ahead of schedule, Patel said. They will now expand their current study from a goal of 30 patients to 50 patients and they plan to start a pivotal trial next year. That will move it significantly ahead of their remaining irritable bowel disease asset, PTG-943. Development of that drug has been pushed back significantly during the Covid-19 pandemic; because it targets IL-23, it could make patients more susceptible to infection.

These are immuno-suppressive agents at the end of the day, Patel said of PTG973. Basically, for now the focus is on blood disorders.

Its a marked shift for Patel and Protagonist. The company spent a decade building its peptide-based platform, and its earliest assets were for IBD. They raised investors confidence around PTG100 and quickly brought it into a Phase IIb study. J&J offered $990 million in a deal centered on a second IBD drug, PTG-200. These drugs appealed particularly because they were oral, unlike the injectables that have dominated the inflammatory disorders market.

The J&J drug is still in the clinic, but in March of 2018, Protagonist announced that PTG-100 failed a futility analysis; an independent review board determined it had no chance of beating placebo. The stock fell 58%, from $20.43 to $8.59, roughly where it sits today.

PTG-100 has since been retired, but Patel claimed the review decision was actually wrong. The company noted a high placebo response in the initial assessment and sent it for a blinded review to a third party and CROs subcontractor, who determined some of the initial endoscopes had been initially misread and the trial should have continued.

Within two days we figured out the endoscopy readouts were errant, he said. The outcome should not have been futile.

The company went back to the FDA with the third party review, Patel said, but the FDA said they had to start a new trial. By that point, though, the company had already come up with PTG-943, which they believed worked better and was wiser to advance if they were going to start a new trial.

Now with Covid-19 pushing back IBD further, blood disorders have become the companys main strategy, despite having only a tiny, open-label data set. Patel is confident, though, that it can be a fruitful one. He said there was a clear regulatory path with a 150-person trial, good effects in those patients, and a significant potential market.

It fits all of the three category: strong data, a good regulatory path forward, and a very large commercial opportunity, he said. So thats where Protagonist will be focused.

Read more:
Two years after a wrenching setback, Protagonist touts a slice of data and sets sights on pivotal trial in a surprising place: the blood - Endpoints...

SOUTH SAN FRANCISCO May 8, 2020 (Thomson StreetEvents) -- Edited Transcript of CytomX Therapeutics Inc earnings conference call or presentation Thursday, May 7, 2020 at 9:00:00pm GMT

CytomX Therapeutics, Inc. - Senior VP & CFO

* Christopher S. Keenan

CytomX Therapeutics, Inc. - VP of IR & Corporate Communications

* Sean A. McCarthy

CytomX Therapeutics, Inc. - Chairman, CEO & President

* Biren N. Amin

* Christopher N. Marai

Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology

H.C. Wainwright & Co, LLC, Research Division - Associate

* Terence C. Flynn

Good day, ladies and gentlemen, and welcome to the CytomX Therapeutics First Quarter 2020 Financial Conference Call. (Operator Instructions)

As reminder, this call may be recorded. I would now like to introduce your host for today's conference, Christopher Keenan, Vice President of Investor Relations. Chris, you may begin.

Christopher S. Keenan, CytomX Therapeutics, Inc. - VP of IR & Corporate Communications [2]

Good afternoon, and thank you for joining us. Earlier today, we issued a press release that includes a summary of our recent progress and our first quarter 2020 financial results. This press release and a recording of this call can be found under the Investors and News section of our website at cytomx.com.

With me today are CytomX President, Chief Executive Officer and Chairman, Dr. Sean McCarthy; and CytomX's newly appointed Chief Financial Officer, Carlos Campoy.

During today's call, we will be making forward-looking statements. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov, including our Form 10-Q filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments or otherwise.

I will now turn the call over to Sean.

Sean A. McCarthy, CytomX Therapeutics, Inc. - Chairman, CEO & President [3]

Great. Thanks, Chris, and good afternoon, everybody. Thanks for your patience as we were getting the call up and running. I gather there's quite a lot of call volume at the moment.

Anyhow, once again, good afternoon, and thanks for joining us. It's a pleasure to be here to provide an update on our progress during the first quarter of 2020. I'll begin today's call with a brief overview of our business operations against the backdrop of COVID-19. And then, we'll review first quarter highlights across the pipeline. I'll then turn the call over to Carlos, our new CFO, you just heard off from Chris, and Carlos will review our first quarter and financial results, and I'll wrap up. And then open the call up for questions.

Let me start by saying that all of us at CytomX hope that you and your families are well and keeping safe during the ongoing pandemic. The situation is impacting all of us in different ways, and it looks like it will continue to do so for some time. We are committed to ensuring the continued well-being of those involved with the conduct of our business. This includes the patients, the staff, physicians engaged in our clinical trials, the vendors and partners who support these trials and, of course, our dedicated employees who continue to impress with their drive and focus during these challenging times.

Despite the operational challenges presented by COVID-19, our team remains highly focused and very mindful that as the American Cancer Society has recently reminded us all, cancer is not waiting, and so neither are we.

At CytomX, we see a major opportunity to more effectively target therapeutic antibodies into disease tissues, generating new classes of anti-cancer therapies. We believe our unique Probody therapeutic platform represents a fundamental advance in the field of antibody engineering, and we are highly focused on using our platform to discover and develop a broad clinical pipeline of novel drug candidates to make a meaningful difference in the treatment of cancer. Our unique science offers the potential for new and highly effective anticancer therapies, including first-in-class molecules against novel undruggable targets, potentially best-in-class molecules against validated targets and new combination therapies.

Probody is our fully recombinant antibody prodrugs comprised of a therapeutic antibody and a mask designed to block the binding of the antibody to its target until the mask is removed. Mask removal is achieved specifically and selectively within cancer tissue by certain disease associated proteins called proteases that we know are present and active in most cancers. Proteases are in effect molecular scissors, which in the context of tumor progression, function to cut a path for invading and metastasizing cancer cells. Our Probody strategy is to leverage tumor proteases to localize antibody activity into cancer tissue, thereby decreasing target engagement in normal tissues and broadening or even creating a therapeutic window.

We have pioneered this new approach, that we believe has the potential to improve and optimize a range of antibody formats, including cancer immunotherapies, antibody drug conjugates and T-cell engaging bispecific antibodies.

Despite the emergence of COVID-19, we had a very productive and important first quarter towards the ongoing advancement of our strategy of developing innovative cancer therapies in areas of significant unmet medical need and with a particular emphasis on undruggable targets.

I'd like to start today's update with CX-2009, our wholly-owned Probody drug conjugate that targets the previously undruggable target CD166. CD166 is a tumor antigen that's expressed a high levels on most solid tumors, but it's also present on most normal tissues, ruling it out as a target for a conventional antibody drug conjugate. Our previously presented data from Phase I dose escalation in various solid cancers has shown CX-2009 to be well tolerated and clinically active as monotherapy at doses of 4 mgs per kg and above. This dose is the threshold of which drug conjugates comprising the DM4 payload, the warhead on CX-2009 have been shown by others to be active in the clinic.

Clinical activity was observed in breast, head and neck and ovarian cancers with CX-2009, and we will be presenting updated data from Phase I dose escalation for this agent at ASCO in a couple of weeks.

In the fourth quarter of 2019, we announced the initiation of a Phase II expansion study of CX-2009 monotherapy in patients with hormone receptor positive HER2-negative breast cancer at a dose of 7 mgs per kg administered every 3 weeks, with the objective of enrolling up to 40 patients. Enrollment was initiated and patients were treated during Q1, but regressively, the COVID-19 situation led us to temporarily pause new patient enrollment and new site activation in this study. Our team continues to closely monitor emerging health authority guidance at IRB/Ethics Committee recommendations and our goal is to resume the CX-2009 clinical program as soon as practical.

Now staying with the theme of undruggable targets, I'd now like to turn to CX-2029,a CD71 targeting Probody drug conjugate that we're developing in partnership with AbbVie, and for which, in Q1, we announced the achievement of a major collaboration milestone.

Long considered a high potential but undruggable antibody drug conjugate target, CD71 is known as a professional internalizer, given its role of moving iron from the extracellular space into intracellular compartments. And it does this in all dividing cells. In fact, many consider CD71 to be the gold standard internalizer to assess the in vitro activity of antibody drug conjugates.

But the presence of CD71 on normal cells has been an impediment to its use as a drug target. CX-2029 is a Probody against CD71, conjugated to the cytotoxic payload MMAE. We recently announced the achievement of prespecified dose escalation success criteria for the CX-2029 Phase I dose escalation study, resulting in a $40 million milestone payment from AbbVie to CytomX. Data from this Phase I study will be the subject of an oral presentation at ASCO 2020.

The CytomX and AbbVie teams are now actually finalizing plans for the initiation of Phase II expansions as soon as possible. CytomX has the responsibility for advancing this program through initial proof of concept, whereupon, if successful, the program will transition to AbbVie for registrational studies and ultimate commercialization. CytomX retained significant U.S. commercial rights to this asset and is also eligible to receive double-digit ex U.S. royalties, should the product reach the market.

I'd now like to move to another unique R&D strategy that we're pursuing at CytomX, which is to use our Probody technology to generate first-in-class agents against undruggable targets in the context of T-cell engaging bispecific antibodies, which I will refer to, going forward as, TCBs. TCBs are highly potent therapeutics, which directs the activity of cytotoxic T-cells to tumors. This approach has the potential to take immunologically cold tumors and make them hot, opening many new avenues for cancer treatment. While clinical advances have been made with this approach in hematologic malignancies, notably with Amgen's CD19 CD3 bispecific Blincyto. Its application in solid tumors has been challenging. The reason for this is that the high potency of TCBs can target normal tissues with low antigen expression, resulting in significant toxicities.

For several years, we've been working at CytomX to research and optimize the Probody or masked versions of TCBs with an initial focus on the EGFR-CD3 target pair. Data published by others has shown that EGFR, whilst the well-validated oncology target is undruggable in the context of a CD3 bispecific, a conventional CD3 bispecific.

After this preclinical findings have shown that Probody TCBs against EGFR could induce tumor regressions and create a therapeutic window for this cancer target. These important findings served as the foundation for our ongoing collaboration with Amgen, which I'll speak about in just a few moments.

Building on our successful research on Probody TCBs, during Q1, we announced a major strategic collaboration in this area with Astellas. Under this new agreement, CytomX and Astellas will collaborate on 4 initial programs focused on the discovery, research, development and commercialization of Probody TCBs targeting undisclosed tumor antigens for the treatment of cancer. CytomX will lead early drug discovery activities with Astellas leading preclinical and clinical development and commercialization activities. Under the terms of the agreement, CytomX received an $80 million upfront payment and is eligible to receive future preclinical, clinical and commercial milestones of over $1. 6 billion, together with tiered royalties on product sales that range from high-single digits into the mid-teens.

For certain targets, CytomX may co-fund a predetermined portion of product development costs and become eligible to receive a prespecified portion of profits in the United States. CytomX may also later elect to co-commercialize products directed towards such targets in the U.S. Research work and the collaboration is underway, and we are thrilled to have Astellas as our newest partner.

Returning now to our Amgen partnership. I'm also delighted to report that we have recently advanced a lead Probody TCB candidate against EGFR that we call CX-904 into IND-enabling studies. This is the first pro TCB from our platform to reach this important landmark. CytomX is responsible for IND filing, which is targeted for late 2021 and for early clinical development. We're very pleased with this excellent scientific progress with our Amgen alliance and with the growing excitement around the potential of the Probody TCB space, as also evidenced by our new partnership with Astellas.

Moving now to our potential best-in-class programs, CX-072, our wholly-owned anti-PD-L1 Probody and BMS-986249, the anti-CTLA-4 Probody partnered with Bristol Myers Squibb.

The CX-072 was the first Probody we advanced into the clinic, and it has provided us with crucial insights and the first clinical proof-of-concept for our platform. We'll be presenting long-term follow-up data from the CX-072 Phase I/II study as an oral presentation at ASCO.

In Q1, as part of our portfolio reprioritization, we announced the termination of the Phase II program combining CX-072 with ipilimumab, the anti-CTLA-4 antibody in patients with relapsed or refractory melanoma. This decision followed a reevaluation of the evolving clinical competitive and commercial landscape in immuno-oncology, taken together with the impact of the COVID-19 pandemic. We continue to evaluate opportunities for the further advancement of the CX-072 program and we plan to initiate combination studies with our second wholly-owned program CX-2009 later this year.

During Q1, we also announced an important pipeline milestone in our foundational oncology collaboration with BMS. The leading edge of this alliance is the anti-CTLA-4 Probody BMS-986249.

CTLA-4, the target of ipilimumab, is the prototypical checkpoint target, and blocking this mechanism has proven highly effective in the treatment of patients with melanoma and other cancer types, both as monotherapy and in combination with PD-pathway inhibitors. While a very important advance, CTLA-4 blockade can cause severe immune-related toxicities, creating a clear opportunity for a Probody version of this agent to improve tolerability, increased duration of treatment and potentially improved activity. BMS and CytomX have previously presented preclinical proof-of-concept for CTLA-4 Probodies at several major research conferences and Phase I clinical data for this Probody will be presented at ASCO.

Based on these Phase I findings, BMS recently initiated a randomized Phase II expansion study comparing the tolerability and activity of BMS-986249, plus nivolumab, to ipi plus nivo in frontline metastatic melanoma. The advancement of the CTLA-4 Probody into this study triggered a milestone payment of $10 million from BMS to CytomX.

This is an important study, that if positive, has the potential to place the ipilimumab Probody on a registrational path.

Moreover, this work is a terrific example of what we set out to do with our platform when it was first conceived of, and we're excited about its potential for cancer patients.

Additional recent progress within our BMS alliance includes the initiation of the dose escalation phase of another clinical study, a Phase I/II study for a second anti-CTLA-4 Probody. We call this BMS-986288. And this is based on a modified version of ipi.

The second clinical Probody program demonstrates BMS' ongoing commitment to our technology platform as a way to potentially unlock additional value in the CTLA-4 mechanism and across other targets.

Before handing over to Carlos, I want to also note that we continue to strengthen our executive leadership at CytomX and with the appointments in Q1 of Carlos, our CFO; and also Dr. Alison Hannah as Chief Medical Officer. Carlos and Alison bring -- each bring over 30 years of leadership experience from across their respective domains, and we are absolutely delighted to welcome them to the team.

I would now like to turn the call over briefly to Carlos.

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Carlos Campoy, CytomX Therapeutics, Inc. - Senior VP & CFO [4]

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Thank you, Sean. I'm very pleased to be here. I'd like to review the financial highlights for the first quarter ending March 31, 2020. Revenue for the quarter was $50 million compared to $29 million in the corresponding period in 2019. The increase was primarily due to the partial revenue recognition of the $40 million milestone earned from AbbVie associated with the CX-2029 project and $10 million related to the milestone earned from BMS associated with the initiation of the Phase II randomized cohort expansion of BMS-986249.

Research and development expenses were $43 million for the quarter compared to $36 million in the corresponding period in 2019. The increase was largely attributed to license and sublicense fees associated with milestones and upfront payments earned in the first quarter of 2020.

General and administrative expenses were flat compared to the corresponding period in 2019. We ended the quarter with cash, cash equivalents and investments totaling $247.9 million compared to $296.1 million as of December 31, 2019.

Our achievements in existing and new partnerships during Q1 have resulted in $130 million in milestone and upfront payments to CytomX that are not reflected in our end of Q1 cash balance. I would like to underscore the company's continued strong track record of executing strategic business development transactions to broaden our pipeline and access additional non-dilutive operating capital. We expect our strong balance sheet to allow us to comfortably meet projected operating requirements into the second half of 2022, assuming no new collaborations or financings.

With that, I'll turn the call back to Sean.

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Sean A. McCarthy, CytomX Therapeutics, Inc. - Chairman, CEO & President [5]

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Great. Thanks, Carlos.

So to wrap up, CytomX had a very strong first quarter of 2020, with many key achievements across our preclinical and clinical programs in our existing partnerships and in the formation of a major new strategic alliance. We have a strong balance sheet to advance our pipeline and weather market uncertainty. And we're looking forward to ASCO, of which we have multiple presentations that will provide important updates on all of our clinical stage programs. I am very proud of the CytomX team for staying intensely focused in these challenging times, as we drive towards making the biggest difference we can for patients with cancer.

So thanks all for your time today. We wish the very best to you and your families. And Chris, please now open the call up to questions.

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Christopher S. Keenan, CytomX Therapeutics, Inc. - VP of IR & Corporate Communications [6]

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Operator, we'll take our first question.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Our first question comes from Peter Lawson with Barclays.

Our next question comes from Peter (sic) [Chris] Marai with Nomura Instinet

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Christopher N. Marai, Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology [2]

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CD166 -- Can you hear me okay?

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Operator [3]

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Yes, sir. You were muted in the beginning. You came on halfway.

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Christopher N. Marai, Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology [4]

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Okay. I'm sorry about that. So what I mentioned is the toxicity around the CD166 program versus the CD71. I'm just curious about the payloads being used here. And the internalization profiles of the targets, given that CD71 is very efficient in internalizing, does that impact the type of payload that you chose to use? I noticed that you 2 different payloads for these products.

Also for the CD71 PDC, I'm curious about what would some expected on target toxicities might look like versus toxicities due to the payload in general?

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Sean A. McCarthy, CytomX Therapeutics, Inc. - Chairman, CEO & President [5]

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Yes. Thanks for the questions. So first of all, with regards to the payloads, going back several years, when we designed the Probody drug conjugate strategy, we made a very conscious decision that the first 2 Probody drug conjugates to take into the clinic that we would work with, the most established warheads or payloads, if you like. And DM4 was selected for the CD166 program through an alliance with ImmunoGen and MMAE, which at the time was the second most validated payload. We were able to access that through our alliance with AbbVie via their alliance with Seattle Genetics. And so frankly, we could have used -- it could have ended up being the other way around. That's just the way it played out at the time. We considered those 2 payloads to be the most and best validated at that time.

In terms of the toxicities with DM4, we've known for a long time that the principal toxicity with DM4 is ocular tox. That's exactly what we saw at the higher doses in our dose escalation in Phase I, is something that is manageable in the form of ocular prophylaxis. So that's something that we're implementing in the ongoing Phase II study.

With regard to CD71 and MMAE, the principal toxicities with MMAE are a little bit different to DM4. They're more hematologic in nature. And that's what we saw in our preclinical studies and hematologic toxicities that we're looking out for in the clinic.

With regards to CD721 on target toxicity, it's very difficult to say. With CD166, just as an example, the target is expressed on most normal tissues and you could, therefore, infer that you may see toxicity of any kind. In fact, in the clinic, we really didn't see any evidence of on target toxicity with our reported data on CD166. We'll provide the data on CD71 Phase I dose escalation in a couple of weeks at ASCO.

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Operator [6]

Follow this link:
Edited Transcript of CTMX earnings conference call or presentation 7-May-20 9:00pm GMT - Yahoo Finance

Prediabetes is when your blood sugar levels are high, but not high enough to be considered type 2 diabetes.

Since prediabetes usually doesn't come with symptoms, doctors recommend getting screened if you have certain risk factors.

Image Credit: FatCamera/E+/GettyImages

"It's sort of an in-between condition," says Sue Kirkman, MD, professor of medicine in the division of endocrinology and metabolism at UNC Health. "It's considered a precursor to type 2 diabetes."

Blood sugar levels that are between 100 and 127 mg/dL are considered prediabetes, according to the American College of Cardiology. Normal is between 70 and 100 mg/dL, and anything above 127 is considered type 2 diabetes.

About one-third of Americans have prediabetes, according to the Centers for Disease Control and Prevention (CDC), although the majority don't know it.

People who have been diagnosed with the condition have a 50 percent chance of moving on to full-blown type 2 diabetes within the next five to 10 years, according to the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK).

"If changes aren't made in eating habits and activity, many people with prediabetes will move into the diabetes category," Julie Stefanski, RDN, a dietitian, certified diabetes instructor and spokesperson for the Academy of Nutrition & Dietetics, tells LIVESTRONG.com.

Even if you don't develop diabetes, though, having prediabetes can up your risk of heart and kidney disease, per the Mayo Clinic.

If you know you have prediabetes, you have the opportunity to take measures to get your blood sugar levels down to a healthy range and prevent the condition from progressing.

Being overweight is a risk factor for prediabetes.

Image Credit: Zero Creatives/Image Source/GettyImages

The biological causes of prediabetes (and diabetes) have to do with insulin resistance.

Insulin is the hormone that guides blood sugar molecules (broken down from the food you eat) out of the bloodstream and into cells, where they're used as fuel. In prediabetes and diabetes, your body either loses the ability to respond properly to insulin or doesn't make enough insulin, which means the sugar levels in your blood build up.

"As prediabetes develops, the body struggles more and more to process certain foods," Stefanski explains. "The pancreas must make higher levels of insulin to take sugar out of the blood and put it into the cells of the body. Eventually the body won't be able to keep up with insulin needs and blood sugar levels will rise."

No one really knows what causes insulin resistance in the first place, though it seems to be a combination of factors.

"The risk factors for prediabetes are the same as risk factors for type 2 diabetes," Dr. Kirkman says. According to the Mayo Clinic, those include:

1. Family history and genetics: If you have a parent or sibling with type 2 diabetes, you're more likely to develop prediabetes (and type 2 diabetes).

2. Age: The risk of developing prediabetes rises after the age of 45.

3. Being overweight or obese: The risk is even greater if fat is concentrated around the abdomen.

4. Waist size: Men with waists larger than 40 inches around and women who have waist circumferences larger than 35 inches are at a higher risk for insulin resistance, even if their body mass index (BMI) is normal, according to the NIDDK.

5. Being inactive: Regular exercise is key to reaching and maintaining a healthy weight and helps your body better process sugar and use insulin.

6. Diet: Red and processed meat along with sugary beverages increase the risk of prediabetes. Eating more fruits, vegetables, whole grains, olive oil and nuts is linked to a lower risk.

7. Gestational diabetes: Women with a history of this pregnancy condition are at higher risk for prediabetes and type 2.

8. Race and ethnicity: African Americans, Hispanics, Native Americans, Asian Americans and Pacific Islanders have a higher risk than other groups.

9. Polycystic ovary syndrome: This hormonal disorder in women, commonly referred to as PCOS, is marked by small cysts on the ovaries, according to the Mayo Clinic.

10. Metabolic syndrome: This condition is marked by high blood pressure combined with abnormal cholesterol levels and a large waist size, per the NIDDK.

11. Other risk factors: Obstructive sleep apnea and smoking may increase insulin resistance. Certain medications and hormonal disorders can also put you at higher risk.

Extreme thirst is one sign of prediabetes.

Image Credit: fizkes/iStock/GettyImages

Like the early stages of diabetes, prediabetes usually doesn't have any symptoms at all. That's why some 90 percent of people with the condition don't even know they have it, Dr. Kirkman says.

Some people may have warning signs, which could include:

Because prediabetes usually doesn't have any symptoms, "it's important to get screening tests if you have risk factors," Dr. Kirkman says.

The American Diabetes Association (ADA) recommends testing be considered in adults who have no symptoms but have a BMI of 25 or higher (23 or higher in Asian Americans) and one or more other risk factors.

Testing should begin for all people starting at age 45. If your results are normal, you don't have to be re-tested for three years, Dr. Kirkman says.

The same three tests that can diagnose diabetes are also used to diagnose prediabetes, according to the Endocrine Society. They are:

1. Fasting blood glucose test (FBG): This is a blood test that takes place after you've been fasting for eight hours (usually overnight) and drinking only water. Prediabetes is when your fasting blood sugar is between 100 and 125 mg/dL, says Dr. Kirkman.

2. Hemoglobin A1c test (HbA1C): This test measures your blood sugar levels over the past three months. Prediabetes is indicated when your numbers are between 5.75 and 6.4 percent, says Dr. Kirkman.

3. Oral glucose tolerance test (OGTT): This test is rarely used, says Dr. Kirkman. That's partly because it's difficult to do. You have to have blood drawn two hours before and after drinking a sugary beverage, all after eight hours of fasting. A result over 140 means you are prediabetic, while over 200 indicates diabetes, per the NIDDK.

Typically, doctors will repeat the tests before giving a diagnosis of diabetes or prediabetes, says Dr. Kirkman.

Lifestyle changes like adding more activity to your days may help prevent prediabetes from turning into type 2 diabetes.

Image Credit: monkeybusinessimages/iStock/GettyImages

Treating prediabetes really means preventing type 2 diabetes, and the sooner you get started the better. The American Academy of Family Physicians (AAFP) notes that the longer you have either condition, the higher the likelihood you'll end up with health complications.

"The main goal is to not advance to the point where you have type 2 diabetes," Dr. Kirkman says. "The treatments are primarily losing weight and exercising or certain medication."

If you're overweight, losing just 5 to 7 percent of your body weight (or 10 to 14 pounds for a 200-pound person) can lower your risk for type 2 diabetes, according to the NIDDK. This will help push your blood pressure and cholesterol levels into healthy ranges, per the AAFP, and most importantly, adds Dr. Kirkman, "some people with weight loss will actually revert to having normal blood sugar."

There's debate about whether you can actually "reverse" prediabetes or even type 2 diabetes but, says Dr. Kirkman, with proper lifestyle changes, you can prevent or indefinitely delay progression.

The best way to lose weight is through diet and exercise, each of which bring their own benefits to the table.

When it comes to diet, there's no one right way to eat if you have prediabetes. One place to start, though, is in the timing of your meals.

"Start by cutting back on the portions of foods you're eating at one time," Stefanski says. "Rather than eating the majority of your food during a few hours at night, spread those choices out more so that the body doesn't have to process everything at the same time."

Did you know that keeping a food diary is one of the most effective ways to manage your weight? Download the MyPlate app to easily track calories, stay focused and achieve your goals!

You can also diminish portion sizes gradually, drink water rather than sweetened beverages and opt for whole fruit over fruit juice.

Green vegetables are a great way to feel full without raising your blood sugar, and the AAFP recommends eating more whole grains, lean proteins and low-fat dairy.

Foods to avoid include those that are processed, fried and sugary.

"No matter what your weight, it's important to become more physically active," Stefankski says. "We've worked regular activity out of our daily lives. As humans, we need to move and stay active to keep processes within the body working appropriately."

The CDC recommends aiming for at least 150 minutes of moderate physical activity each week. Brisk walking is a good option, as are swimming and bike riding.

Research shows that people who get support are more likely to achieve their goals. Indeed, those with prediabetes who enacted changes encouraged by the National Diabetes Prevention Program (DPP), which includes a support component, lowered their risk of developing type 2 diabetes by as much as 58 percent.

There's some controversy as to whether medications can or cannot help people with prediabetes. In one study, though, conducted as part of the DPP Outcomes Study, the medication metformin dropped the risk of developing type 2 diabetes by 31 percent. Ask your doctor if medication might be right for you.

See the article here:
What Is Prediabetes? Causes, Symptoms and Treatment - LIVESTRONG.COM

Boulder May 6, 2020 (Thomson StreetEvents) -- Edited Transcript of Clovis Oncology Inc earnings conference call or presentation Tuesday, May 5, 2020 at 8:30:00pm GMT

Clovis Oncology, Inc. - VP of IR

* Daniel W. Muehl

Clovis Oncology, Inc. - Executive VP & CFO

* Patrick J. Mahaffy

Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director

SVB Leerink LLC, Research Division - MD of Targeted Oncology & Senior Research Analyst

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Kennen B. MacKay

RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research

Thank you for standing by, and welcome to the Clovis Oncology First Quarter 2020 Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions) I'd now like to hand the conference over to your speaker today, Anna Sussman, Vice President of Investor Relations. Thank you. Please go ahead.

Anna Sussman, Clovis Oncology, Inc. - VP of IR [2]

Thanks, Jessie. Good afternoon, everyone. Welcome to the Clovis Oncology First Quarter 2020 Conference Call. Thank you for joining us. You've likely seen this afternoon's news release. If not, it's available on our website. As a reminder, this conference call is being recorded and webcast. Remarks may be accessed live on our website during the call and will be available in our archive for the next several weeks.

Today's agenda includes the following: Pat Mahaffy, our President and CEO, will discuss the key components and highlights of today's corporate update, including commentary about any potential impact related to COVID-19; then Dan Muehl, Clovis' Chief Financial Officer, will cover the quarter's financial results in greater detail; Pat will make a few closing remarks; and then we'll open the call for Q&A, during which time, Lindsey Rolfe, our Chief Medical Officer, will also be available to answer questions.

Before we begin, please note that during today's conference call, we may make forward-looking statements within the means of the federal securities laws, including statements concerning our financial outlook and expected business plans. All of these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Our actual results could differ materially due to a number of factors, including the extent and duration of the effects of the COVID-19 pandemic. Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made, and Clovis undertakes no obligation to update or revise any forward-looking statements.

Now I'll turn the call over to Pat Mahaffy.

Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [3]

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Thanks, Anna. Welcome, everybody. Appreciate you taking the time today. As we all know, the world has changed so much since our last quarterly update in late February. It's a complicated time for all of you, I know. Health care professionals have been and remain on the front lines of this global pandemic and I'd like to acknowledge the contributions of health care workers around the world, putting their lives on the line to care for those affected by COVID-19.

Closer to home, we'd also like to recognize the tremendous effort being made by our investigators and prescribers to maintain enrollment and safely manage ongoing patients in our clinical trials and for continuing to prescribe and manage Rubraca commercial patients during this period of significant upheaval to their clinics and practices.

I'll use our time today to discuss the highlights of the topics you've come to expect on our quarterly calls and focus on providing additional color on how we are navigating the COVID-19 world here at Clovis, and our view of how COVID-19 may affect oncology treatment going forward, and then we'll open it up for Q&A with Dan, Lindsey and myself.

Let's begin with a commercial update for Rubraca. I'm pleased to report that we had a very encouraging first quarter. Our global net revenue was $42.6 million. This represents an 8% sequential increase from Q4 2019 and 29% increase over Q1 2019. This was our best quarter of sales to date, despite the fact that reps had to begin staying home beginning in mid-March in the United States and could no longer call on health care providers in person for the last few weeks of the quarter. Also, our European launches in Italy, Spain and France are all occurring in an environment in which our field-based personnel have not been allowed to visit hospitals or clinics beginning in late February and are therefore also working from home.

Given these circumstances, we are very pleased with our sales growth in the first quarter. And now I'll share why we believe that Rubraca is well positioned as an oncology treatment option in the current acute COVID-19 era, and in the chronic COVID environment that is sure to follow. This period has been very disruptive for hospitals, clinics and patients as health care professionals are redirected, broadly described elective procedures are delayed and health care facilities are converted to support COVID-19 treatment efforts. We do believe that oncology will be among the first health care specialty to return to some normalcy so that likely means adapting to a new normal in a chronic COVID-19 world, one in which there is a focus on minimizing clinical visits to avoid risk to patients, especially cancer patients and other patients with known comorbidities.

It is also clear that cancer patients will need to be diagnosed and treated, given the evident risk in not actively managing their disease. We believe that Rubraca, a convenient oral therapy has significant advantages as a maintenance option in the recurrent ovarian cancer setting in an environment in, as I described, physicians are trying to reduce patient visits to their clinics. Unlike Avastin as a maintenance option that requires frequent infusions and weekly monitoring for hypertension, a known risk factor for COVID-19, Rubraca is an oral agent and is taken at home and only requires monthly routine monitor. Unlike observation, which on average leads to disease progression and requires a return to immunosuppressive chemotherapy after approximately 5 months, Rubraca has been shown to extend progression-free survival and therefore, subsequent chemotherapy, on average, nearly 14 months by independent assessment, nearly 3x longer than placebo. In fact, observation is an invitation to infusion. And unlike ZEJULA, which requires weekly blood monitoring for the first month, which obviously requires weekly visits to the clinic or a laboratory, Rubraca requires only monthly routine monitoring. As you can see, Rubraca offers numerous potential advantages in a chronic COVID-19 world, and we have already introduced a variety of new digital materials for our now home-based field personnel we use to engage with hospitals, clinics, doctors and pharmacies.

While we may see some near-term impact on revenues as physicians adapt their practices to COVID-19, we believe these advantages will remain over the course of this year and future years and as we all know, COVID-19 is not likely going away in the near term.

In addition to seeking to establish Rubraca as the maintenance treatment option of choice in recurrent ovarian cancer, we also look forward to the potential launch in the United States of Rubraca in advanced mutant BRCA prostate cancer, and that brings us to our most near-term development and regulatory program in this setting.

In November 2019, we submitted our planned supplemental new drug application, or sNDA for Rubraca as a monotherapy treatment of adult patients with BRCA1/2 mutant recurrent, metastatic CRPC. The FDA filing was based on data from the TRITON2 clinical program in advanced prostate cancer. In the U.S., by the way, approximately 12% of men with metastatic CRPC have a mutation of BRCA1/2 in their tumor.

In January 2020, we announced that the FDA accepted our sNDA for Rubraca and granted priority review status to the application with the PDUFA date of May 15, 2020. Based on our interactions with the FDA, we have no reason to expect any delay to our May 15 PDUFA date. We think that Rubraca represents an important hormone-free and chemotherapy-free option for men with metastatic CRPC and a BRCA1/2 mutation. Recall that we've previously reported at ESMO last fall, a confirmed objective response rate of 44% by investigator and a confirmed PSA response of 52%. The safety data for men with CRPC were consistent with prior safety reports for patients with ovarian cancer and other solid tumors.

We've been engaged by -- encouraged by our interactions with both the medical oncology and urology communities about the potential for Rubraca to address the unmet medical need in recurrent metastatic CRPC. We are actively engaged in launch preparations, including sales force training that was completed in early March, and we will be ready to launch upon approval. Obviously, this will be among the first group of oncology launches that we'll incur entirely or almost entirely virtually. And we have taken considerable effort to prepare for this virtual launch. Our field sales team is prepared to initiate Zoom-based sales calls with prescribers, and will leverage learnings accumulated through their virtual selling efforts in the ovarian cancer setting since mid-March. All launch collateral for the sales team has been digitized to ensure they have the ability to utilize resources in virtual interactions. The promotional national broadcast has been fully converted to a virtual streaming program enabling HCPs to watch from any computer or iPad or any device in their office or home. Additional broadcast times have been added to ensure flexibility across all U.S. time zones. Program registration will be aided through targeted online advertising that will commence the day of approval. Media and advertising efforts have been weighted toward digital programming versus print to maximize impact and effectiveness of resources invested.

So to be clear, we will be ready to launch in prostate even in this new environment. Let me turn now to the clinical pipeline for Rubraca and lucitanib as well as our ongoing plans for FAP-2286. To begin, we are adhering to the regulatory guidance that FDA and other agencies have provided regarding clinical trial conduct during COVID-19, and our clinical teams are working closely with investigators to assure the safety of trial participants and investigators while maintaining compliance with good clinical practice and minimizing risk to the integrity of our trials.

While we did not see any material disruption to our clinical trials as a result of COVID-19 during the first quarter, it is possible that near-term effects may begin to emerge across different aspects of our clinical trial programs. For example, new patient recruitment in certain clinical studies may be affected, and the conduct of clinical trials may vary by geography as some regions are more adversely affected. I will note that we continue to anticipate completing enrollment in our largest study, the ATHENA frontline maintenance study before the end of this quarter. The LODESTAR study, our Phase II pan-tumor study to evaluate Rubraca in homologous recombination repair genes across tumor types continues to enroll patients. The study will evaluate Rubraca in patients with recurrent solid tumors associated with the deleterious homologous recombination repair or HRR gene mutation. Based on our interactions with FDA, this study may be registration-enabling for a targeted gene and tumor-agnostic label. If enrollment continues as planned, we could potentially file for approval in 2021.

Next, I'd like to briefly highlight our combination studies with BMS for both Rubraca and lucitanib, and then discuss our newest compound, 2286. We remain enthusiastic about our ongoing clinical collaboration with Bristol-Myers Squibb and I'll take a moment to review certain of our combination studies for both Rubraca and lucitanib with nivolumab. I'll begin with the Rubraca combinations.

FRACTION-GC is a BMS-sponsored multi-arm Phase II study evaluating the combinations of each of Opdivo and Yervoy with Rubraca as well as Opdivo, Yervoy and Rubraca in combination for the treatment of advanced gastric cancer. This is the first sponsored study to explore this triplet combination, and it is currently enrolling patients into the safety lead-in portion of the study. The Clovis-sponsored Phase III ATHENA trial in first-line maintenance for advanced ovarian cancer continues to enroll well, despite the COVID-19 environment. And as I noted, we continue to anticipate completing enrollment in this 1,000 patient study in the second quarter of 2020.

With ATHENA, we believe we are uniquely positioned to evaluate Rubraca in terms of 2 outcomes as monotherapy versus placebo in the first-line maintenance setting in the HRD population, inclusive of BRCA and in the all-comers or intent-to-treat population as well as any potential advantage of the combination of Rubraca and Opdivo in the same patient populations. ATHENA is the first frontline switch maintenance study designed to show both PARP monotherapy and PARP/PD-1 combination therapy in one study design. I'll take a moment to remind you of the statistical analysis planned for ATHENA. First, expected in the second half of next year, we will see the results of Rubraca monotherapy versus placebo in all study populations. And then probably a year or more later, we will see the results of Rubraca plus Opdivo versus Rubraca in all study populations. In each of these analyses, we will first evaluate outcomes in the HRD population, including BRCA, and then step down to the entire intent-to-treat population.

To wrap up Rubraca and move to lucitanib, I'll described SEASTAR, our Clovis-sponsored Phase Ib/II study that includes multiple single-arm Rubraca combination studies, including the combination of Rubraca with sacituzumab govitecan, now known as Trodelvy for the treatment of advanced metastatic triple-negative breast cancer, relapsed platinum-resistant ovarian cancer and metastatic urothelial cancers. A separate arm of SEASTAR includes the combination of Rubraca with lucitanib in advanced solid tumors, which is currently in the dose-finding Phase Ib portion of the study.

Lucitanib, of course, is our investigational inhibitor of tyrosine kinases, including vascular endothelial growth factor receptors 1 through 3, platelet-derived growth factor receptors alpha and beta and fibroblast growth factor receptors 1 through 3. In February 2019, we and Bristol-Myers Squibb expanded our clinical collaboration to include planned combinations of Opdivo with lucitanib. The Clovis-sponsored LIO-1 study is a Phase Ib/II study evaluating lucitanib in combination with Opdivo. LIO-1 is now enrolling patients with advanced solid tumors in the Phase Ib portion of the study. We anticipate submitting abstracts for presentations at a medical meeting in the fall of 2020.

Lastly, the BMS-sponsored CheckMate 79X study is a Phase I/II study evaluating multiple combinations with Opdivo including an arm in combination with lucitanib in patients with second-line non-small cell lung cancer. Start-up activities for the CheckMate 79X study are proceeding for regulatory guidelines for clinical trial conduct during COVID-19.

We remain very enthusiastic about our peptide-targeted radiopharmaceutical therapy program, and in particular, our lead compound, FAP-2286. FAP is highly expressed in cancer-associated fibroblast or CAFs, which are found in the majority of cancer types, potentially making it a suitable target across a wide array of solid tumors. It is highly expressed in many epithelial cancers, including more than 90% of breast, lung, colorectal and pancreatic carcinomas. Recent preclinical data in animal models, which we expect will be reported at an upcoming medical meeting, has only increased our optimism around this program.

In addition, we and 3BP are collaborating on a discovery program directed at 3 additional targets for radionuclide therapy, to which we have global rights. We've regone to this program for many reasons, including, of course, the opportunity to be a leader in the emerging field of targeted radiotherapy for the treatment of solid tumors. In this case, we have the opportunity to be the first to clinically develop an FAP-targeted radionuclide, and we are also enthusiastic about the targets of the subject of our planned -- or our ongoing discovery collaboration.

Clovis currently plans to submit an investigational new drug or IND application for FAP-2286 in the second half of 2020, followed by a Phase I study to determine the dose and tolerability of the FAP-targeting therapeutic agent with expansion cohorts planned in multiple tumor types as part of the global development program. Thus far, in radiotherapeutic development, physicians have used an imaging agent to identify patients with the appropriate level of tumor target, in our case, FAP. We are exploring opportunities to generate imaging data for FAP-2286, potentially even before our IND is submitted. Not only would this information be useful to gain additional experience with FAP-2286 and better understand the characteristics of FAP expression in multiple tumor types, but further will allow us to collaborate with other academic institutions eager to explore the potential of FAP-2286 as an imaging and as a treatment modality.

And with that, I'll turn the call over to Dan to discuss first quarter 2020 financial results.

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Daniel W. Muehl, Clovis Oncology, Inc. - Executive VP & CFO [4]

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Thanks, Pat, and hello, everyone. We reported net product revenue for Rubraca of $42.6 million for Q1 2020, which included U.S. net product revenue of $39.3 million and ex-U. S. net product revenue of $3.3 million. This represents a sequential increase of 8% over Q4 2019 net revenue of $39.3 million and a 29% increase over Q1 2019 net product revenue of $33.1 million. U.S. net product revenue was $39.3 million for the first quarter, up 9% from $36.1 million reported in Q4 2019 and up 23% from the $31.9 million reported in Q1 2019. The supply of free drug distributed to eligible patients in the U.S. through the Rubraca Patient Assistance Program for Q1 2020 was 12% of overall commercial supply compared to 18% in Q4 2018. This represented $5.6 million in commercial value for Q1 2020 compared to $8 million in Q4 2019. We can't yet predict the impact of COVID-19 and related unemployment on cap utilization over the remainder of 2020.

Ex-U. S. net product revenue was $3.3 million for the first quarter of 2020, which represents a slight increase over the $3.2 million reported for Q4 2019 and the $1.2 million reported in the first partial quarter of ex-U. S. sales in Q1 2019. We launched Rubraca in France and Spain during March 2020, so we only expected a small contribution in Q1 for those countries. We have now recorded product revenue in each of Germany, United Kingdom, Italy, France and Spain, and we expect to launch into additional smaller European markets over time.

Gross to net adjustments totaled 22.6% in Q1 2020 compared to 17.4% in Q4 2019. The sequential increase in gross to net adjustments reflects primarily an increase in the U.S. contracting and government-related programs and the impact of growing European sales that generally have higher GTN rates. We expect gross to net adjustments to remain in this low 20% range, depending on revenue and distribution mix for the U.S. and Europe. The number of weeks in distributor inventory was flat at the end of Q1 versus Q4, so there was no buildup of inventory as a result -- as a reaction to COVID-19.

At this point in time, we have no issues with either drug supply or distribution of drug to the patient. We have described product supply costs as a meaningful part of our cash spend over the last couple of years as we transition to a new manufacturing facility, so we are in a favorable position for some time to come.

Turning now to a discussion of cash. As of March 31, we had $228.4 million in cash, cash equivalents and available for sale securities. In January 2020, the company repurchased $123.4 million aggregate principal amount of its 4.5% convertible senior notes due 2024 that were initially issued in August 2019. In April 2020, the company exchanged approximately $36 million in aggregate principal amount of its 4.5% convertible senior notes due 2024 in exchange for approximately $32.8 million in aggregate principal of 2021 notes held by such holder. In May 2020, a holder of the 4.5% convertible notes due 2024, converted $24.3 million par value of notes into approximately 3.3 million shares of common stock per the standard terms of the indenture. Following these transactions, approximately $64.4 million aggregate principal amount of these 2021 notes remain outstanding and approximately $150.6 million in aggregate principal amount of these 2024 notes remain outstanding. Additionally, the company has $300 million aggregate principal amount outstanding of its 1.25% convertible notes due 2025.

As a result of the transactions noted above, the company has reduced its total outstanding convertible debt by $145.1 million in outstanding principal amount from December 31, 2019, through May 5, 2020. And as of March 31, we had drawn approximately $50 million under the TPG ATHENA clinical trial financing and had up to $125 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

Based on the company's anticipated revenues, spending, available financing sources and existing cash, cash equivalents and available for sale securities, we believe we have sufficient cash, cash equivalents and available for sale securities to fund our operating plan into the second half of 2021. This does not include any cash repayment that may be required to pay off unless we refinance earlier the remaining $64.4 million aggregate principal amount of the 2.5% convertible notes at their maturity in September 2021. While we did not see an impact in Q1 on our revenues, the effects of COVID-19 on our future sales are difficult to assess or predict, and we may see some near-term impact on revenues related to COVID-19. Net cash used in operating activities was $82.5 million for Q1 2020 compared to $98.5 million for Q1 2019. In addition, borrowings under the TPG ATHENA financing provided $15.6 million in cash in Q1 2020, reducing net cash utilized in operating activities to $66.9 million during the quarter. Net cash used in operating activities for Q1 2020 included product supply costs of $12.4 million and once-a-year annual incentive compensation payment. We expect product supply costs will be significantly reduced from this first quarter level for the remainder of 2020 and at least the first half of 2021. We also expect significantly lower cash burn in the second half of 2020, assuming achievement of our planned revenues over that time frame.

We reported a net loss for Q1 2020 of $99.3 million or $1.39 per share compared to a net loss for the first quarter of 2019 of $86.4 million or $1.63 per share. Net loss for Q1 2020 included share-based compensation expense of $13 million compared to $13.6 million for Q1 2019. Research and development expenses totaled $68.2 million for Q1 2020 compared to $62 million for the first quarter of 2019. The increase is primarily due to higher research and development costs for Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to 2020.

Selling, general and administrative expenses totaled $42.6 million for Q1 2020 compared to $47.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the first quarter of 2020, primarily due to decreased commercialization expenses for Rubraca in the U.S. and Europe. We expect savings in selling, general and administrative expenses as a result of the COVID-19 situation globally.

Lastly, we continue to explore ways to improve our balance sheet and capital structure and extend our cash balance beyond the second half of 2021. As noted, we expect our R&D expenses to decrease in 2021 compared to 2020. SG&A expenses should be lower in the upcoming months, and we expect they will be in line with the Q1 2020 levels through 2021. Our inventory purchases and other nonrecurring milestone payment expenses will significantly decrease through 2021, and we anticipate planned revenues to increase with growth in all geographies and with our anticipated prostate indication approval and launch in the U.S. All of these factors should contribute to a reduction in quarterly cash burn into and through 2021. Back to you, Pat.

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [5]

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Thanks, Dan. In summary, we're pleased with our progress in the first quarter, and we believe that Rubraca is well positioned as a maintenance therapy of choice for recurrent ovarian cancer patients in the acute and in the coming chronic COVID-19 environment. Physicians will continue to seek to reduce patient visits to their clinics, and Rubraca offers certain advantages to achieve this goal. Rubraca is an oral agent delivered to and taken at home. Rubraca has been shown to extend progression-free survival by independent assessment by nearly 14 months on average compared to placebo or observation, which has shown PFS of only 5 months on average. And Rubraca requires only monthly routine monitoring, thus limiting patient visits to the clinic. We believe these equalities offer a compelling argument for clinicians to consider Rubraca in the maintenance setting for recurrent ovarian cancer. And soon, we hope to offer a new therapeutic option for BRCA-mutant recurrent, metastatic castrate-resistant prostate cancer patients in the U.S. as well.

We remain focused on managing our net cash utilized operations and improving our balance sheet through convertible debt and other transactions such as the transactions which occurred in January, April and May of this year. And last, but certainly not least, I'd like to acknowledge our employees, all of whom have been working from home since mid-March, and I am grateful for their ongoing commitment to support patients, health care providers and each other during this challenging and unprecedented time.

And with that, we're happy to answer any questions you may have.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from Kennen MacKay with RBC Capital Markets.

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Kennen B. MacKay, RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research [2]

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Congrats on the operational progress despite the pandemic. Pat, it seems like maybe you really have had some tailwinds from the COVID pandemic going on, obviously, arising from some of the decreased toxicity on the myeloid department. Can you maybe talk about how this could read through to prostate cancer, given some of the alternative agents and the chemotherapies that are out there have maybe even more toxicity than the PARP class.

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [3]

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Yes. As you're aware, both ASCO and FDA have encouraged physicians to consider oral therapeutics as they consider treatment options for patients. And obviously, we hope and believe that, that will continue to accrue to our advantages. I discussed not only in the ovarian cancer setting versus certain alternative infusion based products, but versus immunosuppressive chemotherapy in prostate cancer.

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Operator [4]

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Your next question comes from Gena Wang with Barclays.

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Huidong Wang, Barclays Bank PLC, Research Division - Research Analyst [5]

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Maybe first one is, any geographic differences in terms of a COVID-19 impact regarding launch? And also, second question is regarding the prostate cancer. Should we actually expect any revenue in second quarter?

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [6]

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Yes. So first, as the geographic differences regarding the launch, yes. We -- it's pretty evident that, for instance, the New York metropolitan area has been hit pretty hard. And I think we probably did see an impact on sales, at least new patient starts in New York, maybe even during the quarter. As to the prostate cancer launch, there will likely be some hotspots, where distractions to the health care system occur and could temporarily impact on prescribing. I will say that with a PDUFA date on May 15 and being prepared to launch on or before May 15, we absolutely would expect to see sales in prostate cancer in the second quarter. We'll have 6 weeks of sales.

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Huidong Wang, Barclays Bank PLC, Research Division - Research Analyst [7]

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Okay. That's very helpful. If I may just squeeze one more question. Any thoughts on ZEJULA approval in the first-line ovarian cancer? And then, how would that impact the competitive landscape and your ATHENA trial readout?

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [8]

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So one, it was totally expected. And so it came as expected and are approved. It is not going to have any impact on our ATHENA readout. The trial is almost fully enrolled, so it will have no impact on enrollment, obviously. And in fact, we aren't even enrolling in the United States. We've started shutting down country by country, certain areas, and we've already shut down enrollment in the U.S. So it will have no impact on the timing of our readout for ATHENA.

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Operator [9]

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Your next question comes from Michael Schmidt with Guggenheim Securities.

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Yige Guo, Guggenheim Securities, LLC, Research Division - Associate [10]

Excerpt from:
Edited Transcript of CLVS earnings conference call or presentation 5-May-20 8:30pm GMT - Yahoo Finance

How to relieve constipationEat in a relaxed state

Make sure you dont stress eat, otherwise you will continue to be constipated.

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Hannah explained: Remember a stressed state equals constipation! The very act of eating food creates peristalsis along the tract- a series wave-like muscle contractions that move food to different processing stations in the digestive tract.

This will stimulates defecation. The process of removing faces from your bowels.

For this movement to occur, the gastrocolic reflex should be unconscious.

The gastrocolic reflex is a physiological reflex that controls the movement of the gastrointestinal tract after a meal.

When you feel the urge to go to the toilet, just go!

Hannah said: Your gut is wired to nature. The more you suppress the need, the harder and drier the stool becomes.

This in turn can cause the internal bleeding of the tract, and you dont want this.

Although this would normally be a minor issue if the digestive tract is severely bleeding it could be life-threatening.

Hannah said: As Annie said: when a girl/boys gotta go! So remember to never suppress the need!

In fact, you could try to go to the toilet twice a day.

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You will feel emotionally and physically free. You cant beat a good full, clean bowel movement!

Hannah said: Constipation is not a symptom of a poor diet, its a sign that the entire digestive system is sub optimal.

Making sure you are hydrated and have adequate fibre in your diet, which would mean having vegetables at every meal, is an absolute requirement for a healthy bowel.

If you add to the problem, by smoking, and drinking alcohol and coffee in excess amounts, then it will be even harder to solve the problem.

Look at your habits and lifestyle traits and make positive changes.

See the original post:
Constipation: How to relieve constipation - Express

Unlike Type 1 or Type 2 diabetes, Type 3 diabetes isnt an official clinical diagnosis. Its not an established medical

Unlike Type 1 or Type 2 diabetes, Type 3 diabetes isnt an official clinical diagnosis. Its not an established medical term at least not yet, points out Guojun Bu, chair of the department of neuroscience at Mayo Clinic in Jacksonville, Florida. But experts say the concept is still a useful one that speaks to the link between insulin resistance in the brain and dementia caused by the progressive brain disorder Alzheimers disease.

Insulin, a hormone produced by the pancreas, regulates glucose levels in the blood. With insulin resistance, the cells dont respond well to the hormone. That can lead to higher blood-sugar levels and the development of Type 2 diabetes (and before that, prediabetes, a precursor to the chronic condition). Research shows that, even short of a person developing diabetes, insulin resistance can impact the body and brain and lead to a range of health complications.

The concept of Type 3 diabetes comes from the idea that insulin resistance is linked, in many cases, to Alzheimers dementia, making it yet another form of diabetes. Of course, the term is also an oversimplification, says Dr. Gary Small, a professor of psychiatry at the UCLA Semel Institute and author of The Small Guide to Alzheimers Disease, since the association isnt completely understood.

Where it breaks down is that its not a 100% link not all patients who have Alzheimers disease have insulin resistance, and not all people who have insulin resistance have Alzheimers disease, Small explains. Now one could argue it could be a subtype of Alzheimers disease where theres that link.

[See: 9 Habits That May Reduce Your Risk for Developing Alzheimers.]

Insulin Resistance Isnt Limited to Diabetes

Today, more than 30 million people in the U.S. have diabetes, according to the Centers for Disease Control and Prevention. And many more people have insulin resistance which isnt routinely tested for.

Even though insulin resistance is associated with diabetes, its much more common than diabetes, says Suzanne Craft, a professor of gerontology and geriatric medicine and director of the Alzheimers Disease Research Center at the Wake Forest School of Medicine in Winston-Salem, North Carolina. It can lead to diabetes, but it can also cause a host of other complications Alzheimers disease being one of those. Those who have insulin resistance, particularly at mid-life, are at greater risk for developing Alzheimers disease, Craft says.

There is a lot of literature supporting the association between insulin resistance and various types of dementias that disproportionately affect older patients, particularly Alzheimers disease, echoes Dr. Samoon Ahmad, a professor of psychiatry at the NYU Grossman School of Medicine and founder of the Integrative Center for Wellness in New York City. Insulin resistance in Alzheimers is a growing area of focus. As noted in a 2018 review article in the Frontiers in Neuroscience, The epidemiological connection between diabetes, obesity, and dementia represents an important public health challenge but also an opportunity to further understand these conditions. The key intersection among the three diseases is insulin resistance.

The association also applies to conditions that are related to insulin resistance, including Type 2 diabetes and obesity, notes Christian Pike, a professor in the Leonard Davis School of Gerontology at the University of Southern California.

Researchers arent exactly sure why insulin resistance is associated with higher rates of Alzheimers disease and related forms of dementia. But theres no shortage of theories and possible mechanisms that have been suggested to explain the relationship. And, generally speaking, its well-known that insulin plays an important role in brain function.

Insulin basically transports glucose from the bloodstream into cells, Small says. So that makes sense if your insulin transport system getting those nutrients to brain cells is not functioning properly, that the brain is not being fed its main energy source as well.

Insulin has a number of important roles to play in healthy brain function, Craft notes. Accordingly, she says, there are several pathways through which insulin resistance could increase the risk for Alzheimers disease. For one thing the hormone helps brain cells form connections. It helps the brain repair itself from injury and generate new brain cells, Craft says. It plays a very important role in memory.

So dysfunction in regards to how insulin is used or isnt can have a meaningful impact on cognitive function. Insulin resistance, by definition, is the brain not responding normally to insulin, Craft explains. So by depriving the brain of all of these various functions of insulin, insulin resistance creates an environment in the brain that makes it vulnerable to developing the kind of injury thats associated with Alzheimers disease.

Given the important role of insulin, it could be used as a possible treatment for mild cognitive impairment and Alzheimers disease, as noted in a 2018 research review published in the Journal of Neurology. Insulin delivered through a nasal spray, for instance, has been shown to improve recall of story details or story recall in patients with Alzheimers or mild cognitive impairment.

Ultimately, insulin may be delivered as a means to improve or at least stabilize cognition in people with Alzheimer and other dementias. In limited studies, intranasal insulin delivery has been shown to lead to some cognitive benefits in dementia patients, Pike points out.

Theres evidence that the Alzheimers brain may be less sensitive to insulin, which is critical for memory formation and maintenance, Bu adds. But more research is needed to explore the possibilities for managing or treating Alzheimers with insulin.

In the meantime, whats already well established is that preventing insulin resistance can protect a persons overall health including brain health.

[See: 10 Myths About Diabetes.]

Preventing Insulin Resistance Through Lifestyle Changes

Factors out of ones control namely genetics, having a family history of insulin resistance or diabetes can predispose a person, or raise ones risk of developing insulin resistance. But lifestyle still plays an outsized role in preventing it.

Lifestyle changes are among the most effective ways of preventing or delaying Alzheimers disease, too. And they are recommendations weve all heard before, Craft says.

Those include:

Getting regular exercise.

Consuming a healthy, balanced diet.

Maintaining a healthy weight.

If a person did all of those things, the rate of insulin resistance would be dramatically reduced, Craft says.

What we dont understand is why some people have a greater tendency to develop insulin resistance than others, even when their diets and levels of exercise are more or less than the same, Ahmad says. Genetics is likely one answer, but there may be other factors we are not aware of, and these may complicate the association between Alzheimers risk and diet.

Even so, the role of lifestyle remains important. While some individuals are at a significantly higher risk of developing either diabetes or Alzheimers because of genetic factors, getting regular exercise and eating healthy will certainly lower ones risk of developing Type 2 diabetes and could lower ones risk of developing Alzheimers disease, Ahmad adds.

Federal physical activity guidelines suggest getting at least 150 minutes of moderate intensity exercise, like brisk walking, weekly. Shifting to a sustainable, well-rounded, balanced eating pattern rather than say an extreme diet is also encouraged.

While most people like to hear about fad diets that produce unrealistic or unsustainable results, the best way to plan ones meal is to avoid excessive amounts of alcohol and processed foods particularly those high in saturated fats and sugars and to try to eat foods that are as close to their whole or natural states as possible, Ahmad says. This means a diet that is rich in whole grains, lean proteins, and fruits and vegetables, particularly raw fruits and vegetables.

From improving heart health to brain health and staying disease-free in general for as long as possible data strongly suggests turning away from a traditional Western diet thats heavily processed and high in saturated fat and sugar. This type of eating pattern has been linked with a higher risk of Alzheimers disease.

[See: Best Foods for Brain Health.]

The kind of diet that protects the brain is generally a Mediterranean-style diet that includes fresh fruits and vegetables, legumes, healthy fats from omega-3s which are anti-inflammatory, Small says. You can get omega-3 fats from fish and nuts. He notes that the fruits and veggies provide antioxidants and may fight against wear and tear from oxidative stress that causes damage to neurons over the years. A diet that limits refined sugars and processed foods will lower risk for Type 2 diabetes as well as Alzheimers dementia.

More from U.S. News

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Type 3 Diabetes? The Link Between Insulin Resistance and Alzheimer?s originally appeared on usnews.com

Read the original here:
Type 3 Diabetes? The Link Between Insulin Resistance and Alzheimer's - WTOP

As the rumblings of a pandemic began to be felt at the beginning of the year, scientists at Penn started work to develop a vaccine and assess possible treatments. But the scope of COVID-19 studies at the University goes much broader. Scientists whose typical work finds them investigating autoimmune disease, influenza, HIV/AIDS, Ebola, cancer, hemophilia, and more, are now applying their deep understanding of biology to confront a novel threat.

The more scientists and clinicians observe about the virus, the more avenues of investigation emerge, aiming to shed light on questions such as what happens once the virus enters the body, what treatments might be of benefit, and how society should take action to keep transmission low.

To dig into what scientists around campus are asking and learning, Penn Today spoke with several who have pivoted their research to focus on COVID-19. Their work, while in its early days, is in many cases already finding applications in the fight against this ferocious virus, and may well shape the next steps to defeat it.

Another respiratory infection, influenza, has been a focus of research led by Andrew Vaughan of the School of Veterinary Medicine. But Vaughan didnt hesitate to begin studies of the novel coronavirus once its eventual impact became apparent.

Its not a stretch for our lab, he says. All the projects in our lab focus on repair and regeneration of the lungs after injury. The majority of my studies are to some degree agnostic about what is causing the injury.

Earlier work by his group, for example, showed that a lung cell transplant could boost healing in mice affected by a severe bout with flu. Now, graduate students and research specialists in his labworking no more than two together at a time to maximize social distancingare conducting new experiments focused more specifically on the biology of SARS-CoV-2, alongside parallel efforts by Edward Morrissey from the Perelman School of Medicine (PSOM). Knowing that the Ace2 receptor on lung cells is the gateway for the virus into the human body, theyre genetically manipulating alveolar type-two lung cells, those that are particularly essential for continuing oxygen exchange deep in the lungs, to alter or block ACE2 gene expression to try to prevent viral entry.

These alveolar type-two cells seem to be particularly susceptible to injury in both influenza and perhaps even more so in COVID-19, says Vaughan. In a perfect world, you might be able to take these genetically edited type-two cells and use them as a cellular therapy. I dont know that this is going to happen in time to impact this pandemic, but even if the pathogen the next time around is slightly different, we may still be able to employ these types of regenerative responses to help the lung recover better from injury.

In a separate project, Vaughan is partnering with Penn Vets Montserrat Anguera to explore a curious feature of COVID-19 disease: the fact that more men than women become severely ill and die. A number of hypotheses have been put forward to explain the disparity, but the two labs are investigating one particular possibility.

Dr. Anguera had posted something on Twitter saying that the ACE2 gene happens to be on the X chromosome, meaning that women have two copies of it, says Vaughan. I immediately texted her and said, I think theres something to that.

Normally women inactivate one of their X chromosomes, but some genes can escape this inactivation. This means its possible women may have higher ACE2 expression than men. Somewhat counterintuitively, scientists have actually found that higher ACE2 levels actually reduce lung injury, even though ACE2 is also what the virus depends on to enter cells.

Hormone expression levels are, of course, another factor that may influence sex differences in disease. Together, Anguera and Vaughans groups are both studying ACE2 expression and exposing alveolar type-two cells to various hormones to see how expression of viral receptors, Ace2 and others, changes. Ultimately wed like to see if this changes susceptibility to infection, working with Susan Weiss and others, says Vaughan.

Individual differences in how people respond to infection may be influenced by their unique genomic sequences. Penn Integrates Knowledge Professor Sarah Tishkoff of PSOM and the School of Arts & Sciences, is probing the rich sources of genomic data her group already had in hand to look for patterns that could explain differences in disease susceptibility. As in Vaughan and Angueras work, ACE2 is a focus.

This gene is very important for general health, Tishkoff says. Women have two copies, men have one; it plays a role in regulating blood pressure; its in the kidneys; its in the gut. We want to understand the role that variation at this gene may play in risk for COVID-19, severity of disease in people with underlying health conditions, and differences in the prevalence of disease in men and women.

Using genomic data from 2,500 Africans collected for another project, Tishkoffs team is looking for patterns of genetic diversity. Early findings suggest that natural selection may have acted upon on version of the ACE2 gene, making it more common in some African populations with with high exposure to animal viruses.

Shes also collaborating with Anurag Vermaand Giorgio Sirugo of Penn Medicine to analyze genetic variation in samples from the Penn Medicine Biobank, looking in particular at people of African descent. Were seeing disturbing health disparities with COVID, with African Americans at higher risk for serious illness, says Tishkoff. This disparity mostlikelyhas to do with inequities in access to health care and socioeconomic factors, but were also looking to see if genomic variation may be playing a role.

Looking ahead, Tishkoff hopes to partner with Daniel Rader and others through the Center for Global Genomics and Health Equity to work with the West Philadelphia community. Wed like to do testing to understand the prevalence of infection and identify environmental and genetic risk factors for disease, she says.

The immune reaction to SARS-CoV-2 is a double-edged sword. The immune system is what eliminates the virus, says E. John Wherry of PSOM. The immune system is what we need to activate with a good vaccine. But also, especially in many respiratory infections, the immune system is what also causes damage. A healthy outcome means your immune system is striking a balance between killing off the virus and not doing so much damage that it kills you.

Wherry and PSOMs Michael Betts have embarked on a study to discern both the magnitude of patients immune responses as well as their flavor, that is, what components in the immune system are being activated by the coronavirus. Theyre doing so by working with clinicians at the Hospital of the University of Pennsylvania (HUP) and, soon, at Penn Presbyterian Medical Center, to collect blood samples from patients with severe and more mild infections, as well as patients who have recovered from illness, to profile their immune reactions.

Its one of the beautiful things about Penn. Everyone is working as a team, being selfless, being present, and bringing all their expertise to bear on this crisis. E. John Wherry, Perelman School of Medicine

We are observing a huge amount of heterogeneity across these patient samples, says Betts. But were also identifying some relatively unifying characteristics, indicating there are mechanisms that everyone uniformly uses to fight off this infection.

This variety across patients strongly suggests that the treatments that work for one patient may not for another, Wherry and Betts note. For that reason, they are speaking daily with their colleagues on the front lines of COVID-19 care, relaying what theyre finding out in the lab to adjust and personalize care in the clinic.

Its one of the beautiful things about Penn, says Wherry. Everyone is working as a team, being selfless, being present, and bringing all their expertise to bear on this crisis.

Plenty of recent scientific attention has been paid to the role of the gut microbiome in health. But the medical schools Ronald Collman and Frederic Bushman have been devoting attention to how the community of bacteria, viruses, fungi, and parasites that dwell in the respiratory tract affect health and disease risk. They are now addressing that question in the context of COVID-19.

There are two reasons were interested in studying this, Collman says. First is that the microbiome can help set the tone for the immune response to infections, influencing whether a patient ends up with mild or severe disease. And second, the microbiome is where infectious agents that can cause infection can arise from. So if a patient dies of an eventual pneumonia, the pathogen that caused that pneumonia may have been part of that individuals respiratory tract microbiome.

Working with nurses at HUP to collect samples, Collman and Bushman are analyzing the microbiome of both the upper (nose and throat) and lower (lung) portions of the respiratory tract of COVID-19 patients. These samples are being used by other groups, such as those developing diagnostic tests, while Collman and Bushmans labs work to identify the types and quantities of organisms that compose the microbiome to find patterns in how they correlate with disease.

Were hoping that if we can find that the response to the virus is different in people with different upper respiratory tract microbiomes, then we could manipulate the microbiome, using particular antibiotics, for example, to make it more likely that patients would have a mild form of the disease.

Absent a vaccine, researchers are looking to existing drugssome already approved by the U.S. Food and Drug Administration for other maladiesto help patients recover once infected. Throughout his career, Ronald Harty of Penn Vet has worked to develop antivirals for other infections, such as Ebola, Marburg, and Lassa Fever.

Our antivirals are sometime referred to as host-oriented inhibitors because theyre designed to target the interaction between host and viral proteins, says Harty. Though many of the biological details of how SARS-CoV-2 interacts with the human body are distinct from the other diseases Harty has studied, his group noticed a similarity: A sequence hes targeted in other virusesa motif called PPxYis also present in the spike protein of SARS-CoV-2, which the coronavirus uses to enter cells.

This caught our eye, says Harty, and piqued our interest in the very intriguing possibility that this PPxY motif could play a role in the severity of this particular virus.

Harty is testing antivirals he has helped identify that block the replication of Ebola, Marburg, and other viruses to see if they make a dent on the activity of SARS-CoV-2. Those experiments will be done in collaboration with colleagues whose labs can work in BSL-III or -IV laboratories, such as Penns Weiss.

Also of interest is the speculation that the coronavirus might disrupt cell-cell junctions in the human body, making them more permeable for virus spread. Hartys lab will be examining the potential interactions between the viral structural proteins and human proteins responsible for maintaining these cellular barriers.

Another faculty member is assessing whether a drug developed for a very different conditionin this case, pulmonary arterial hypertension (PAH)could serve coronavirus patients. Henry Daniell of the School of Dental Medicine recently shared news that a drug grown in a plant-based platform to boost levels of ACE2 and its protein product, angiotensin (1-7), was progressing to the clinic to treat PAH. Daniell is now working with Kenneth Margulies from Penn Medicine to explore whether this novel oral therapy can improve the clinical course of patients with symptomatic COVID-19 infection.

Reduced ACE2 expression has been linked to acute respiratory distress, severe lung injury, multi-organ failure and death, especially in older patients. The earlier preclinical studies in PAH animal models showed that orally delivered ACE2 made in plant cells accumulated ten times higher in the lungs than in the blood and safely treated PAH. Now, new clinical studies have been developed to explore whether oral supplementation of ACE2 and angiotensin-1-7 can help mitigate complications of COVID-19 disease. The fact that freeze-dried plant cells can be stored at room temperature for as long as a year and can be taken at home by COVID-19 patients make this novel approach an attractive potential option.

This trial has been given a high priority by the Penn Clinical Trial Working Group, says Daniell. Im pleased that this looks to be on the cusp of moving forward to help the growing number of COVID-19 patients.

As the coronavirus began to spread in the United States, biologist Joshua Plotkin of the School of Arts & Sciences began to raise alarms about Philadelphias St. Patricks Day parade, which had been scheduled to be held March 15, potentially drawing thousands to downtown streets. He had good reason to be concerned: His studies of the 1918 flu pandemic had explored disease incidence and spread, and it was hard to avoid noticing the role of the Liberty Loan parade down Broad Street in triggering a rampant spread of flu a century ago.

Now, with work conducted with two graduate students from Princeton University, Dylan Morris and Fernando Rossine, along with Princeton faculty member Simon Levin, Plotkin has mathematically sound advice for policymakers hoping to effectively stem the spread of a pandemic. In a preprint on arXiv.org, they share optimal, near-optimal, and robust strategies for how to time interventions such as social distancing.

This boils down to knowing what is the best way, of all the infinite possibilities, to intervene using public health measure, says Plotkin. Thats a problem we can solve with math, my colleagues Dylan and Fernando realized.

Their analysis makes the realistic assumption that policymakers can only enforce social distancing for a limited amount of time, and aims to minimize the peak incidence of disease. The optimal strategy, they found, is to start by introducing moderate social distancing measures to keep the incidence rate the same for a period of time. This would mean that every person with COVID-19 would infect one additional person. Then the intervention should switch over to a full suppressionthe strongest possible quarantinefor the rest of the period. At the end of that period, all restrictions would be lifted.

This works because you dont want to fully suppress disease spread right off the bat, says Plotkin, because then at the end, after you remove restrictions, there will be a second peak that is just as large as the first. By employing a moderate suppression at the beginning, youre building up a population of people who are going to recover and become immune, without letting the epidemic get out of control.

Unsurprisingly, timing is key. Attempting the optimal intervention would be disastrous, in practice, because of inevitable errors in timing. Intervening too early is pretty bad, because you get a bigger second peak, he says. But intervening too late is even worse. The key lesson is that a robust intervention is more important than an optimal one.

Plotkin and his colleagues are hoping to share the findings widely, including with local decision makers, to help them navigate a likely second wave of COVID-19.

Montserrat Anguera is an associate professor of biomedical sciences at the University of Pennsylvania School of Veterinary Medicine.

Michael Betts is a professor of microbiology at the University of Pennsylvania Perelman School of Medicine.

Frederic Bushman is the William Maul Measey Professor in Microbiology at the University of Pennsylvania Perelman School of Medicine.

Ronald Collman is a professor of Medicine at the University of Pennsylvania Perelman School of Medicine.

Henry Daniell is vice-chair and W.D. Miller Professor in the Department of Basic and Translational Sciences in the University of Pennsylvania School of Dental Medicine.

Ronald Harty is a professor of pathobiology and microbiology at the University of Pennsylvania School of Veterinary Medicine.

Kenneth Margulies is a professor of medicine and physiology and research and fellowship director of the Heart Failure and Transplant Program at the University of Pennsylvania Perelman School of Medicine.

Joshua Plotkin is the Walter H. and Leonore C. Annenberg Professor of the Natural Sciences in the Department of Biology at the University of Pennsylvania School of Arts & Sciences. He has secondary appointments in the Department of Mathematics and in the School of Engineering and Applied Sciences Department of Computer and Information Science.

Sarah Tishkoff is the David and Lyn Silfen University Professor with appointments in the Perelman School of Medicines Department of Genetics and the School of Arts and Sciences Department of Biology. A Penn Integrates Knowledge Professor, she is also director of the Penn Center for Global Genomics and Health Equity.

Andrew Vaughan is an assistant professor of biomedical sciences at the University of Pennsylvania School of Veterinary Medicine.

E. John Wherry is chair of the Department of Systems Pharmacology and Translational Therapeutics, director of the Institute for Immunology, and the Richard and Barbara Schiffrin Presidents Distinguished Professor at the University of Pennsylvania Perelman School of Medicine.

Homepage image: Researchers around the University are taking a variety of approaches to study the novel coronavirus (particles of which are shown in purple), informed by past expertise and newly formed collaborations. (Image: National Institutes of Health)

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Coming together to solve the many scientific mysteries of COVID-19 - Penn: Office of University Communications

It is possible to feel good and be resilient in times of stress, including the stressful time of menopause transition. The body changes of menopause can be detrimental to individual women, her community and the workplace. With Mothers Day on May 10 and Womens Health Week from May 10-16, addressing the impact of menopause is good for all in West Michigan.

When a woman crosses into menopause, her health is essentially as good as it is going to get. Menopause symptoms which include hot flashes, low sec drive and mood changes affect the quality of life for 80% of women, according to a 2015 study.

Menopause body changes lead to a dramatic increase in risk for obesity, heart attack, diabetes and depression. Because of this, hot flashes can be used to signal it is time to assess risk factors and make decisions about a womans health goals, lifestyle choices and treatment options. For example, estrogen is safer than many people think. Estrogen use early in menopause can reduce the risk for cardiovascular disease without increasing risk for breast cancer and while improving quality of life or a plant-based diet could reduce risk of heart attack.

The symptoms of perimenopause and menopause also can impact the bottom line for businesses. Scientific review of insurance claim data shows women with untreated symptoms of menopause hot flashes, night sweats had 57% fewer days of productive work, were more likely to miss days at work and have more medical office and ER visits with increased medical costs of $1,346 per patient per year, according to a 2015 study. Health care visits for women with symptoms totaled more than $340 million in direct cost, and the total cost of lost work was $28 million.

Experts say these symptoms and the related health consequences lead women to be more likely to leave the workforce or have their careers affected just at the time of potential upswing or promotion. Companies would benefit from increased attention to the benefits of addressing employee health needs around the menopause transition.

Menopause also affects our community by its effect on a womans sense of self, her work life and her family life. It is time to expand the conversation and better care for our community. Menopause happens to all women, either naturally around age 52 or prematurely as a result of cancer treatment or removal of the ovaries due to surgery for cancer or benign conditions such as fibroids or endometriosis.

Women benefit when they are empowered with knowledge about symptoms and treatment options, including targeted lifestyle choices, hormone or other medication, or therapies such as acupuncture. Women whose symptoms are treated spend less time going to the doctor, more time engaged in activities and less prone to chronic illness. West Michigan-based True Womens Health, a midlife, menopause and sexual health wellness clinic, aims to equip women with the right tools and resources to support optimal health for each patient through the good and the bad times.

With Mothers Day and Womens Health Week in mind, it is crucial to continue healthy aging year-round. As a patient of mine who survived breast cancer and works as a supervisor on a factory floor said, The SEEDS (Seven Essential Elements of Daily Success) and medication you prescribed saved me. I am back and happy with my new normal.

She and others like her have proven to me that all women deserve choices on how to cope with their menopause journey, which is the ultimate goal for our True Womens Health patients. When this happens, the whole community will benefit.

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Continuing healthy aging through motherhood and beyond - grbj.com