Archive for December, 2020

SHANGHAI, China, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the first patient has been dosed in the Phase 3 registration Asian study EVER-132-002 evaluating TrodelvyTM (sacituzumab govitecan) versus treatment of physicians choice (TPC) in subjects with hormonal receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2) metastatic breast cancer (mBC).

EVER-132-002 is a Phase 3 Asian study designed to assess and compare the efficacy and safety of sacituzumab govitecan versus TPC in Asian patients with HR+/HER2- mBC who received at least two, and no more than four systemic chemotherapy regimens. The trial will enroll up to 330 HR+/HER2- mBC patients in China mainland, Taiwan and South Korea. The primary endpoint is progression free survival (PFS) per RECIST v1.1 by an Independent Review Committee.

HR+/HER2- breast cancer is the most prevalent subtype of breast cancer and accounts for more than 60% of all breast cancer cases. There is a significant unmet need for new treatment options for women with HR+/HER2 mBC who have failed initial standard-of-care chemotherapies, said Dr. Yang Shi, Chief Medical Officerfor Oncology at Everest Medicines. The clinical data generated to date suggested promising clinical activity of sacituzumab govitecan in HR+/HER2 mBC patients who have failed at least two chemotherapy regimens. We are very excited to initiate our Phase 3 registration trial as we believe sacituzumab govitecan has tremendous potential to become the new standard of care in patients with pre-treated HR+/HER2 mBC.

Immunomedics (now part of Gilead Sciences, Inc), which developed sacituzumab govitecan, is currently recruiting patients for the TROPiCS-02 trial, an open-label, randomized, multi-center Phase 3 study to compare the efficacy and safety of sacituzumab govitecan versus the TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- mBC, after failure of at least two, and no more than four, prior chemotherapy regimens for metastatic disease.

About Sacituzumab Govitecan

Sacituzumab govitecan is a first-in-class antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. Sacituzumab govitecan was granted accelerated approval by the U.S. FDA in April 2020 for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. In September 2020 at the ESMO2020 annual conference, Immunomedics (now part of Gilead Sciences, Inc.) presented the confirmatory Phase 3 trial results (ASCENT) demonstrating that sacituzumab govitecan significantly improved progression free survival (PFS) and overall survival (OS) over standard single agent chemotherapy in pre-treated metastatic triple-negative breast cancer (mTNBC) patients with a hazard ratio of 0.41 and 0.48 respectively. Under a licensing agreement with Immunomedics, Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

In October 2020, sacituzumab govitecan was included in the updated 2020 Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer in China, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

About HR+/HER2- Breast Cancer

Hormone Receptor Positive, HER2 Negative (HR+/HER2-) breast cancer is the most common form of breast cancer in China, representing over 60% of all breast cancer cases. This subtype of breast cancer grows in connection with estrogen or progesteroneand is likely to respond to hormone therapies initially, but almost all HR+/HER2- metastatic breast cancers becomerefractory over time.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Companys therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. Everest Medicines obtained the development and commercial right in greater China, South Korea and certain Southeast Asian countries of sacituzumab govitecan from Immunomedics in April 2019. For more information, please visit its website at http://www.everestmedicines.com.

Everest MedicinesMedia in US and Europe: Darcie RobinsonVice PresidentWestwicke PR(203) 919-7905darcie.robinson@icrinc.com

Media in China: Edmond LococoManaging DirectorICR Asia+86 (10) 6583-7510edmond.lococo@icrinc.com

Originally posted here:
Everest Medicines Announces First Patient Dosed in Phase 3 Registration Asian Study of TrodelvyTM (sacituzumab govitecan) for Hormone Receptor...

It may be possible for some postmenopausal women to avoid some breast cancer treatment without compromising survival, according to two new studies presented at the San Antonio Breast Cancer Symposium (SABCS), hosted by UT Health San Antonio, the American Association for Cancer Research, and the Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine.

The meeting was held virtually December 8 to 11.

One study found that postmenopausal women with early-stage breast cancer who were at low risk of recurrence can skip chemotherapy after surgery. The other found that older patients may be able to skip radiation therapy following breast-conserving surgery.

The studies reflect a resolve in the oncology field to avoid overtreatment of disease, sparing patients from some of the side effects that can accompany treatments like chemotherapy and radiation.

Were looking to move beyond a one-size-fits-all approach, said the presenting author of the first study, Kevin Kalinsky, MD, director of the Glenn Family Breast Center at Winship Cancer Institute of Emory University. This is another step forward in trying to achieve precision medicine.

Dr. Kalinskys study followed women with hormone receptor-positive (HR positive), HER2-negative breast cancer the most common form of breast cancer for about five years following treatment.

The 5,083 study participants had early-stage lymph node-positive cancer (meaning the cancer had spread to one to three lymph nodes) and a recurrence score of 25 or lower.

Breast cancer recurrence scores are based on the presence of 16 cancer-related genes and can range from 0 to 100.

All the study participants received endocrine therapy following surgery, while about half were randomly assigned to receive chemotherapy as well.

The study, which was organized by the SWOG Cancer Research Network and is called RxPONDER, found that while additional chemotherapy improved disease-free survival rates by about 5 percent for premenopausal women, postmenopausal patients gained no added benefit.

This will save tens of thousands of women the time, expense, and potentially harmful side effects that can be associated with chemo infusions, Kalinsky said.

Questions remain about whether chemotherapy has different biological effects based on menopausal status, or simply exerts its effect by shutting down ovarian function.

In the second study, known as PRIME II, researchers found that older patients with HR-positive breast cancer may be able to skip radiation treatment after breast-conserving surgery.

The study enrolled 1,326 women ages 65 and older who had HR-positive breast cancer that had not spread. All of the women had breast-conserving surgery and received hormone therapy. Half of the study participants were assigned to also receive radiation therapy after surgery.

Previous research has suggested a higher risk of cancer recurrence among patients who do not receive radiation therapy. However, the new study found no significant differences in survival, metastasis (disease spread), or new breast cancers among the two groups after five years of follow-up.

The study is important because many postmenopausal women are diagnosed with less-aggressive breast cancers but still receive whole-breast radiation therapy following breast-conserving surgery.

Over half the patients diagnosed with breast cancer in developed countries are over the age of 65 years, said Ian Kunkler, MBBCh, a professor of clinical oncology at the Western General Hospital at the University of Edinburgh in Scotland. We were interested in determining whether older patients with low-risk breast cancer could be spared radiation therapy.

We found that omitting postoperative radiation therapy did not compromise survival or increase the risk of distant metastasis, Dr. Kunkler said. Based on these results, we believe that omission of radiation therapy after breast-conserving surgery should be an option for older patients with localized, HR-positive breast cancer who are receiving adjuvant hormone therapy and meet certain clinico-pathological criteria.

The study findings may not be applicable to patients with high-grade tumors or tumors larger than 3 centimeters, he said, because there were only a few patients with grade-three tumors in the study.

RELATED: Everyday Healths Building a Breast Cancer Community Twitter Chat: Heres What You Missed

A fresh analysis of the landmark phase 3 monarchE clinical trial showed adding Verzenio (abemaciclib) to endocrine therapy significantly benefits patients with high-risk, lymph-node positive, early-stage breast cancer thats classified as HR-positive, HER2-negative.

Many patients with HR-positive, HER2-negative early-stage disease will not experience a recurrence of cancer with endocrine therapy alone, said the study presenter, Priya Rastogi, MD, associate professor in the department of medicine at the University of Pittsburgh and medical director of the National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation.

But about 20 percent of patients will experience a recurrence of the disease within 10 years of their initial diagnosis. These recurrences are typically diagnosed as incurable metastatic breast cancer, she said.

An earlier release of data from the trial, which includes 5,637 patients, showed the addition of Verzenio to endocrine therapy curbed the risk of invasive disease recurrent by about 25 percent. The new data, which followed patients for longer, showed that those who received Verzenio experienced a 28.7 percent reduced risk of invasive disease.

Since some women experience relapse several years after their initial treatment, it will be important to gather long-term data on the treatment regimen, said SABCS codirector C. Kent Osborne, MD, professor in the department of medicine, hematology, and oncology at Baylor College of Medicine in Houston. Dr. Osborne was not involved in the study.

The study will continue with a longer-term assessment of overall survival rates among the two groups.

RELATED: New Treatment for Aggressive Breast Cancer Announced at ESMO 2020

Women with breast cancer who undergo radiation therapy may have side effects that go unreported or unnoticed by healthcare providers, according to a study from the University of Michigan.

The study was comprised of 9,868 patients with breast cancer who were treated with radiation therapy. Researchers compared the patients reports of side effects with those assessed by their physicians.

The study showed physicians tended to under-recognize pain severity as well as itching (pruritus), swelling, and fatigue. Among the 5,510 patients who reported at least one substantial symptom during radiation therapy, 53.2 percent had under-recognition of at least one of the four symptoms.

Recognition of symptoms is necessary for appropriate supportive care, said Reshma Jagsi, MD, DPhil, the Newman Family Professor and deputy chair of the department of radiation oncology and director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan in Ann Arbor.

This work reveals that [physicians] systematically miss substantial symptoms in certain patients, including patients who are younger or of Black or other race.

The study points to the need for physicians to improve the way they assess side effects in patients, said SABCS codirector Virginia Kaklamani, MD, a professor of medicine in the division of hematology and medical oncology, University of Texas Health Sciences Center in San Antonio. Dr. Kaklamani was not involved in the study.

Its really quite surprising to me that in 30 percent of cases there was under-recognition compared to what patients are reporting, she said. We need to do a better job.

I think the key here is improving physician-patient communication, she said. That involves a spectrum of potential interventions which begins with addressing our own unintentional biases.

RELATED: Closing the Gap in Breast Cancer Care and Support for Black Women

Read the original post:
Less Treatment May Be Fine for Some Women With Breast Cancer - Everyday Health

Sara M. Tolaney, MD, MPH, discusses where she sees the treatment landscape evolving in the future for the treatment of patients with hormone receptor-positive metastatic breast cancer.

Sara M. Tolaney, MD, MPH, associate director of the Susan F. Smith Center for Womens Cancers; director of Clinical Trials, Breast Oncology; and senior physician at Dana-Farber Cancer Institute, and assistant professor of medicine at Harvard Medical School, discusses where she sees the treatment landscape evolving in the future for patients with hormone receptor (HR)-positive metastatic breast cancer.

There have been many advancements over the last several years for the treatment of patients with HR-positive metastatic breast cancer, but Tolaney believes there will be a shift towards combination therapy in the future. Current treatment options in the include the combination of endocrine therapy with CDK4/6 inhibition, while physicians may also consider mTOR or PI3K inhibition with endocrine therapy.

In terms of moving forward, Tolaney says 1 major consideration will be combination strategy, which is under exploration in several clinical trials today. These studies are aiming to move the use of CDK4/6 inhibition forward, as well as treatments in the adjuvant setting and treatment with mTOR and PI3K inhibitors as partners for combination strategies. Tolaney says there are many options and new directions for replacing endocrine therapy backbones and perhaps moving into the earlier disease settings. However, first robust data from monotherapy trials are needed.

Continued here:
Combination Strategy May Play Role in Treatment of HR+ Metastatic Breast Cancer - Targeted Oncology

This activity offers CE credits for:

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The goal of this activity is to inform readers about the possible connections between infertility and mental health disorders.

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Understand the prevalence of mood and anxiety disorders in women experiencing infertility and undergoing infertility treatment

Identify patients who may need psychiatric support during infertility treatment

Appreciate factors that may modulate vulnerability to stress, anxiety, and depression in the context of infertility and its treatment

Identify appropriate treatment options for mood and anxiety disorders in women undergoing infertility treatment

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Ms Clayton is an MD candidate (class of 2021) at Tufts University School of Medicine. Dr Nonacs is clinical assistant professor in the Department of Psychiatry at Massachusetts General Hospital and editor in chief at the MGH Center for Womens Mental Health.

Difficulty with conceiving can have many psychological repercussions. Infertility is defined as the inability of a couple to conceive after 12 months of regular intercourse without the use of contraception in women aged 35 years or younger, or after 6 months in women aged 36 years or older. The Centers for Disease Control and Prevention (CDC) reports that 12% of women aged 15 to 44 years have difficulty getting pregnant or carrying a pregnancy to term (Figure). Some form of infertility was reported by 9% of men aged 25 to 44 years. In about 35% of couples surveyed, infertility was due to both male and female factors.1

Infertility can have a profound impact on psychological well-being for both the individual and the couple. A woman may find herself feeling betrayed by her body and may be overcome by emotions, ranging from profound despair to anger and resentment, when a friend announces a pregnancy. Sexual intimacy can morph from an expression of closeness to a demand for conception. Each failed cycle is a multifaceted burden. In vitro fertilization (IVF) is rarely covered by insurance. Some individuals may even become suicidal with recurrent loss of pregnancy.

While we acknowledge that infertility and its treatment are physically and psychologically challenging, there is a paucity of research into the association between psychiatric illness and infertility (Table 1). Additionally, we know little about the psychological impact of infertility and prolonged exposure to infertility treatment on mood and well-being. As the current research stands, it is unclear how mood and anxiety disorders impact fertility and if infertility and its treatment may lead to mood and anxiety disorders.

Impact of affective disorders on fertility and its treatment

There are conflicting data regarding the impact of depression and anxiety on the reproductive cycle. In one study, it was observed that depressive symptoms were not associated with changes in reproductive hormone levels,2 but other studies have found that self-reported levels of stress do impact hormone levels.3 In a group of young women aged 17 to 20 years,higher ratings of stress were associated with lower estradiol (but not testosterone or progesterone) concentrations. This finding is consistent with previous studies suggesting that prolonged perceived stress may lower overall estradiol production, thus inhibiting ovulation and suppressing reproduction.

Inflammation may also play an important role in infertility, and current research suggests that chronic inflammation may affect fertility and pregnancy outcomes. Chronic stress, depression, and anxiety have all been associated with inflammation and, therefore, may interfere with attempts to conceive. In a study of women and men undergoing infertility treatment, higher stress levels were associated with various markers of inflammation, including higher cervicovaginal inflammatory cytokines. These inflammatory markers were, in turn, associated with a decreased likelihood of achieving pregnancy through IVF.4

It is likely that high levels of cumulative stress associated with recurrent depression and/or anxiety may affect multiple stages of fertilization. That said, normal levels of stress related to infertility treatment probably have minimal effects. A prospective study from Donarelli and colleagues5 examined anxiety and stress levels in women and men pursuing infertility treatment before undergoing ovarian stimulation. The researchers found that neither partners level of treatment-related stress had an impact on the number of ovarian follicles greater than 16 mm, with ovarian follicle size being a predictor of IVF success.

Health care providers can reassure patients that neither partners situational stress will impact follicle stimulation. Additionally, it has been speculated that chronic stress impedes successful implantation, but difficulty with implantation can be overcome using IVF. Although more research is needed, IVF may be a reasonable recommendation for women with mood disorders who are experiencing infertility.6

Although it is unclear whether depression affects fertility, it may have an impact on treatment with assisted reproductive technology (ART). Health care providers should be aware that women with depression are less likely to pursue infertility treatment. A recent prospective study of patients attending a fertility clinic found that women who screened positive for depression were about half as likely to initiate treatment for infertility compared with their nondepressed counterparts.7 Additionally, depression in women has been associated with higher ART dropout rates. One study found that couples with a clinically depressed female partner were 5 times more likely to discontinue treatment than couples with a nondepressed partner.8 Screening for depression is therefore important in couples pursuing infertility treatment, and extra care should be taken to provide appropriate support to patients seeking infertility treatment who screen positive for an affective disorder.

Eating disorders and infertility treatment

Infertility and subfertility may occur in women with anorexia nervosa (AN), bulimia nervosa (BN), and binge eating disorder (BED). In women with active illness, amenorrhea and oligomenorrhea can compromise the likelihood of conception (Table 2). Menstrual irregularities occur most commonly in women with AN, with 39% to 42% experiencing amenorrhea (an absence of menstruation) and an additional 6% to 11% reporting oligomenorrhea (infrequent menstruation); however, 7% to 40% of women with BN report amenorrhea and 36% to 64% experience oligomenorrhea.9

The strongest predictors of amenorrhea in women with eating disorders are low body mass index (BMI), low caloric intake, and higher levels of exercise. Weight restoration is the primary intervention for amenorrhea in women with eating disorders, although amenorrhea may persist even after normal weight has been restored.In addition, polycystic ovarian syndrome (PCOS) may be another factor contributing to menstrual irregularity in this population, as PCOS is common among women with BN and BED. In fact, one study reported polycystic ovaries in 75% of women with BN.9

Women with a current eating disorder may experience fertility problems, especially if they have a low BMI and experience menstrual irregularity. However, data regarding the fertility of women with a history of an eating disorder have yielded mixed results.Many studies, including 2 large, population-based cohort studies, have demonstrated similar rates of successful pregnancy in women with a history of an eating disorder compared with women in the general population.10 At the same time, prospective data from the Avon Longitudinal Study of Parents and Children (ALSPAC) indicate that women with a history of AN or BN were more likely to take longer than 6 months to conceive and were more likely to have conceived with the aid of fertility treatment.11

While we do not have detailed information on the impact of other psychiatric disorders (such as bipolar disorder and schizophrenia) on fertility, it should be noted that certain medications used to treat these disorders may cause menstrual irregularities, including amenorrhea, and may thus negatively affect fertility. For example, antipsychotic agents with strong antagonism of the dopamine D2 receptor, such as risperidone and older antipsychotics, increase levels of prolactin, causing hypogonadotropic hypogonadism and subsequent menstrual dysfunction.12

Finally, drug and alcohol use disorders have well-documented effects on the fetus, but the effects on conception and implantation of an embryo are unclear. Studies have suggested that substance use disorder has a negative impact on female and male fertility, but more research is needed in this area.13 The majority of data have come from animal models. Studies in humans have been observational and are complicated by participants who use multiple substances and different routes of administration. Explicit associations between substance use and fertility is further confounded by lifestyle factors that often accompany substance use, such as overall unhealthy lifestyle, poor decision-making, and comorbid physical and mental health disorders.14

Psychological impact of fertility treatment

The decision to begin ART can be very stressful for couples, and research has shown that stress may increase with each subsequent fertility treatment.15 However, distress can manifest at any point during ART. In a large Dutch study following couples experiencing infertility (who reported undergoing an average of 4.3 fertility treatments over 5 years), a passive-avoidant method of coping (eg, hoping for a miracle) was linked with psychological distress in women, and this effect increased over time. For men, this coping style led to increased marital distress.16 Women who perceived infertility as central to their identity, and who were resistant to realigning their goals, reported greater distress during fertility treatment.17 On the other hand, meaning-based coping strategies, learning to grow from a negative experience, and/or finding other goals in life were associated with decreased distress in women, but not in men. A womans use of meaning-based coping strategies also decreased marital stress for both partners.16 It is important to note that these studies are based in countries where fertility treatment is covered by insurance, which is rare in the United States. American couples undergoing ART have additional stressors, although they would also likely benefit from these coping strategies.

Protective factors have also been identified. For a woman, having a higher level of education and adequate social supports decreases distress during ART. For men, a problem-solving coping strategy was linked to a higher self-reported quality of life (QOL).15 In a study from Israel, where there is a social emphasis on having children, researchers observed that maintaining daily routines and making efforts to feel normal led to a higher QOL and better adjustment to fertility treatment.18 In another study, the Dyadic Adjustment Scale (DAS), a tool that measures relationship distress, was administered to couples currently undergoing fertility treatment. Higher dyadic adjustment was associated with better QOL and less psychological distress in both men and women undergoing ART. However, this protective effect was diminished when infertility persisted for longer than 3 years.15

Although multiple studies have assessed psychological distress in couples undergoing treatment for infertility, far fewer have assessed the prevalence of clinically significant anxiety and depressive symptoms in this population. A large Danish study of couples undergoing ART found severe depressive symptoms in 11.6% of women and 4.3% of men.19 These symptoms correlated to an increase in infertility-related distress. However, there is considerable variation among studies with regard to rates of depression and anxiety in couples pursuing infertility treatment, which may reflect differences in type of ART, duration of infertility, number of failed cycles, cultural considerations, and methods used to assess symptoms.

According to another study, women who conceived through ART showed no difference in anxiety and depressive symptoms compared with pregnant women who conceived naturally. However, rates of depression and anxiety were higher in subfertile, nonpregnant women (57.6% and 15.7%, respectively).20 Comparisons between women undergoing repeated IVF cycles and first-time participants have suggested that ongoing treatment may lead to an increase in depressive symptoms, which may persist for 6 months after a failed ART trial.21

Recent research also suggests that both women and men with a history of major depressive disorder (MDD) are more likely to experience depressive symptoms during ART.22 In a prospective observational study of 25 women with a history of MDD undergoing ART, 44% of the women experienced a depressive relapse; rates of relapse were similar among women who maintained antidepressant use compared with those who discontinued treatment.23

In another study, researchers observed that among 108 women undergoing IVF for the first time, those with a history of unipolar depression or anxiety disorder reported more depressive symptoms than controls without these disorders. The group without psychiatric illness responded to fertility treatment with elevated cortisol levels (compared to baseline), whereas women with a history of mood or anxiety disorder had a blunted cortisol response. These results may indicate that infertile women with Axis I disorders may have chronically elevated levels of cortisol, even before entering into infertility treatment.24

Clinical recommendations

Steps should be taken to screen couples, not just women, for psychiatric disorders and chronic stress prior to beginning infertility treatment, as well as throughout treatment. Although depressive symptoms and anxiety occur frequently in women experiencing infertility, many women do not seek treatment. In fact, many women resist disclosing their mental health status to their reproductive endocrinologist for fear that they would be deemed bad candidates for infertility treatment. Effectively treating eating disorders, substance use disorders (including alcohol and tobacco use), and bipolar disorder from the initiation of infertility treatment will aid in a healthy pregnancy, if conception is successful.

Although there is no evidence to suggest that antidepressants or anxiolytic medications negatively affect fertility or infertility treatment, many women are reluctant to use medication in this setting. Women undergoing infertility treatment may not engage in treatment of anxiety and depression because they already feel overburdened by the demands of infertility treatment on their time and financial resources. In addition, having to pursue psychiatric treatment in this setting may accentuate the shame and stigma many women with infertility often feel.

Providing couples with information normalizes the psychological effects of infertility and its treatment may help patients adjust to and tolerate the process. Clinicians should give guidance when psychological symptoms are more than a normal reaction to a common reaction to failed ART. Counseling patients on the importance of self-care, healthy coping strategies, and improving communication may have a positive impact on both the individual and couple. Patient support can include connecting them with community support resources, such as RESOLVE (a network of groups affiliated with the National Infertility Association), and recommending a consultation with a sex therapist to help the couple maintain a positive connection with each other.

Additionally, targeted psychological interventions may help alleviate the adverse psychological outcomes associated with infertility and its treatment, including anxiety, depressive symptoms, and marital stress (Table 3). According to a recent meta-analysis25 that included 39 studies and a total of 3064 women and 347 men, psychological interventions, most commonly cognitive behavioral therapy (CBT) or mind-body interventions (MBI), may be effective for reducing anxiety (25 studies), as well as depressive symptoms (21 studies). These interventions also appeared to improve rates of pregnancy; in this meta-analysis, women treated with CBT or MBI were about twice as likely to achieve pregnancy compared with women receiving usual care. Of note, larger reductions in anxiety were associated with greater improvements in pregnancy rates.

To date, there is no research that specifically looked at the pharmacologic treatment of depression or anxiety in women with infertility. Thus, the same principles that guide the treatment of women during pregnancy should inform the treatment of women undergoing infertility treatment. There are sufficient data to support the use of selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs), bupropion, and tricyclic antidepressants. Other factors that may influence the selection of an antidepressant include prior response to a particular antidepressant, comorbidity of anxiety symptoms, and adverse effect profile.

Benzodiazepines, including lorazepam and clonazepam, may be helpful for the management of anxiety disorders, treatment-emergent anxiety, and sleep disturbance. Althoughearlier reports suggested an increased risk of cleft lip and palate associated with prenatal benzodiazepine exposure, more recent reports have shown no increase in the overall risk of malformations in children exposed to benzodiazepines during pregnancy.26

Many women question whether the use of these medications may affect fertility or the success of infertility treatment. Although there is no evidence to indicate that antidepressants or benzodiazepines have deleterious effects on fertility, this has not been studied systematically. There have been reports suggesting a small but statistically significant increase in risk of miscarriage in women treated with SSRIs, although this is not a universal finding.27 It is also important to note that women who suffer from mood and anxiety disorders probably carry a slightly higher risk of miscarriage. In fact, women with a history of depression who stop treatment with an antidepressant 3 to 12 months prior to conception have the same risk of miscarriage as women who continue treatment with an antidepressant.28

Although avoiding treatment with a medication may seem like the safest option, untreated anxiety and/or depression in the mother has been associated with negative pregnancy outcomes, including increased risk of preterm birth, low birth weight, and other complications.29 In addition, depression during pregnancy is a robust predictor of postpartum depression. Numerous somatic complaints are treated with medication during pregnancy; psychological complaints can be just as detrimental and should be treated, as well.

Concluding thoughts

Infertility is a common and psychologically distressing experience, both for the individual and the couple. Although there is a dearth of research examining the association between infertility and psychiatric illness, preliminary research indicates that depression, anxiety, and chronic stress may contribute to inflammation and alterations in hormone levels, factors which may affect the likelihood of successful pregnancy outcomes. Additionally, ongoing infertility treatment has been linked to increased depressive symptoms and anxiety and may hinder couples ability to pursue and continue with infertility treatment.As noted, eating disorders can also affect fertility.

Increased psychological support during infertility treatment would be beneficial for this population and may improve the chances of a successful pregnancy. The patient undergoing infertility treatment should be given the same plan of care as any patient with anxiety or depression. Support should include expectation management around the psychological effects of infertility treatment, as well as promotion of healthy coping strategies, such as taking time for self-care. If needed, pharmacotherapy with SSRIs or benzodiazepines is unlikely to have an adverse effect on conception and may decrease ART dropout. However, more research is needed to establish the connection between psychological illness and depression in order to create effective targeted therapies.

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References

1. Reproductive Health: Infertility FAQs. Centers for Disease Control and Prevention. Updated January 16, 2019. Accessed November 7, 2019. https://www.cdc.gov/reproductivehealth/infertility/index.htm

2. Prasad A, Schisterman EF, Schliep KC, et al. Depressive symptoms and their relationship with endogenous reproductive hormones and sporadic anovulation in premenopausal women. Ann Epidemiol. 2014;24(12):920-924.

3. Roney JR, Simmons ZL. Elevated psychological stress predicts reduced estradiol concentrations in young women. Adapt Human Behav Physiol. 2015;1(1):30-40.

4. Haimovici F, Anderson JL, Bates GW, et al. Stress, anxiety, and depression of both partners in infertile couples are associated with cytokine levels and adverse IVF outcome. Am J Reprod Immunol. 2018;79(4).

5. Donarelli Z, Lo Coco G, Gullo S, et al. Infertility-related stress, anxiety and ovarian stimulation: can couples be reassured about the effects of psychological factors on biological responses to assisted reproductive technology? Reprod Biomed Soc Online. 2016;(3):16-23.

6. Zaig I, Azem F, Schreiber S, et al. Womens psychological profile and psychiatric diagnoses and the outcome of in vitro fertilization: is there an association? Arch Womens Ment Health. 2012;15(5):353-359.

7. Crawford NM, Hoff HS, Mersereau JE. Infertile women who screen positive for depression are less likely to initiate fertility treatments. Hum Reprod. 2017;32(3):582587.

8. Pedro J, Sobral MP, Mesquita-Guimares J, . Couples discontinuation of fertility treatments: a longitudinal study on demographic, biomedical, and psychosocial risk factors. J Assist Reprod Genet. 2017;34(2):217-224.

9. Kimmel MC, Ferguson EH, Zerwas S, Bulik CM, Meltzer-Brody S. Obstetric and gynecologic problems associated with eating disorders.Int J Eat Disord. 2016;49(3):260-275.

10. Tabler J, Utz RL, Smith KR, Hanson HA, Geist C. Variation in reproductive outcomes of women with histories of bulimia nervosa, anorexia nervosa, or eating disorder not otherwise specified relative to the general population and closest-aged sisters.Int J Eat Disord. 2018;51(2):102111.

11. Schmidt U, Sharpe H, Bartholdy S, et al. Treatment of anorexia nervosa: a multimethod investigation translating experimental neuroscience into clinical practice. Programme Grants Appl Res. 2017;5(16):95-107.

12. Lania A, Gianotti L, Gagliardi I, Bondanelli M, Vena W, Ambrosio MR. Functional hypothalamic and drug-induced amenorrhea: an overview. J Endocrinol Invest. 2019;42(9):1001-1010.

13. Sansone A, Di Dato C, de Angelis C, et al. Smoke, alcohol and drug addiction and male fertility.Reprod Biol Endocrinol. 2018;16(1):3.

14. de Angelis C, Nardone A, Garifalos F, et al. Smoke, alcohol and drug addiction and female fertility.Reprod Biol Endocrinol. 2020;18(1):21.

15. Zurlo MC, Cattaneo Della Volta MF, Vallone F. Predictors of quality of life and psychological health in infertile couples: the moderating role of duration of infertility. Qual Life Res. 2018;27(4):945-954.

16. Peterson BD, Pirritano M, Christensen U, et al. The longitudinal impact of partner coping in couples following 5 years of unsuccessful fertility treatments. Hum Reprod. 2009;24(7):1656-1664.

17. Neter E, Goren S. Infertility centrality in the womans identity and goal adjustment predict psychological adjustment among women in ongoing fertility treatments. Int J Behav Med. 2017;24(6):880-892.

18. Benyamini Y, Gozlan M, Weissman A. Normalization as a strategy for maintaining quality of life while coping with infertility in a pronatalist culture. Int J Behav Med. 2017;24(6):871-879.

19. Peterson BD, Sejbaek CS, Pirritano M, Schmidt L. Are severe depressive symptoms associated with infertility-related distress in individuals and their partners? Hum Reprod. 2013;29(1):76-82.

20. Joelsson LS, Tydn T, Wanggren K, et al. Anxiety and depression symptoms among sub-fertile women, women pregnant after infertility treatment, and naturally pregnant women. Eur Psychiatry. 2017;45:212-219.

21. Milazzo A, Mnatzaganian G, Elshaug AG, et al. Depression and anxiety outcomes associated with failed assisted reproductive technologies: a systematic review and meta-analysis. PLoS ONE. 2016;11(11): e0165805.

22. Holley SR, Pasch LA, Bleil ME, et al. Prevalence and predictors of major depressive disorder for fertility treatment patients and their partners. Fertil Steril. 2015;103(5):1332-1339.

23. Freeman MP, Lee H, Savella GM, et al. Predictors of depressive relapse in women undergoing infertility treatment. J Womens Health. 2018;27(11):1408-1414.

24. Zaig I, Azem F, Schreiber S, et al. Psychological response to cortisol reactivity to in vitro fertilization treatment in women with a lifetime anxiety or unipolar mood disorder diagnosis. J Clin Psychiatry. 2013;74(4):386-92.

25. Frederiksen Y, Farver-Vestergaard I, Skovgrd NG, et al. Efficacy of psychosocial interventions for psychological and pregnancy outcomes in infertile women and men: a BMJ Open. 2015;5(1):e006592.

26. Andersen JT, Andersen NL, Horwitz H, et al. Exposure to selective serotonin reuptake inhibitors in early pregnancy and the risk of miscarriage. Obstet Gynecol. 2014;124(4):665-61.

27. Grigoriadis S, Graves L, Peer M, et al. Benzodiazepine use during pregnancy alone or in combination with an antidepressant and congenital malformations: systematic review and meta-analysis. J Clin Psychiatry. 2019;80(4).

28. Jarde A, Morais M, Kingston D, et al. Neonatal outcomes in women with untreated antenatal depression compared with women without depression: a systematic review and meta-analysis. JAMA Psychiatry. 2016;73(8):826-837.

29. Wu P, Velez Edwards DR, Gorrindo P, et al. Association between first trimester antidepressant use and risk of spontaneous abortion. Pharmacotherapy. 2019;39(9):889-898.

Read the original here:
The Intertwining Effect of Mood Disorders and Infertility - Psychiatric Times

Hundreds of physicians and other medical professionals in the Abortion Pill Rescue Network aid women who experience regret after starting the chemical abortion process. And each provider has their own story for how they came to help women in this critical situation have a second chance at life for their child.

According to a recent report from the Charlotte Lozier Institute (CLI), a "surge" in chemical abortions is contributing to a rise in abortion rates.

Chemical abortion is a two-pill process. The first chemical, mifepristone (or RU-486) is the first pill used in a chemical abortion and blocks the effects of progesterone, a hormone necessary for a pregnancy to thrive. The second part, misoprostol, expels the baby.

However, some moms take that first chemical abortion pill and then regret doing itwhich is why the Abortion Pill Rescue Network (APRN), managed by Heartbeat International, plays such a critical role.

Available 24/7 through the network for moms who experience such regret, the abortion pill reversal (apr) protocol offers hope that the chemical abortion process may be reversed if initiated within a specific timeframe.

When one of these women connects with Heartbeats Option Line, consultants assist women with immediate needs before referring them to the nearest one of more than 700 Abortion Pill Rescue (APR) providers worldwide in the APRN.

[Click here to subscribe to Pregnancy Help News!]

One of those providers is Karen D. Poehailos, MD, who has been working with the APRN since 2015. She has successfully helped a number of moms and their babiesincluding her very first reversal baby, who recently turned five years old.

In celebration of this milestone, I spoke with Poehailos to learn more about her background, her journey to the pregnancy help community, her experiences as an APRN provider, and the impact this has had upon her life.

Poehailos is a board-certified family physician and the Regional Medical Director for ThriVe Central VA Women's HealthCare, a group of four womens health care centers with locations in Charlottesville, Albemarle, Culpeper and Orange, Virginia. She is also a family physician part-time at WellFamily Medicine in Charlottesville.

Her responsibilities with ThriVe Central Virginia include oversight of the paid and volunteer medical personnelas well as providing and coordinating limited obstetrical ultrasound, medical visits, and testing and treatment for sexually transmitted infections (STIs) and sexually transmitted diseases (STDs).

Poehailos is a graduate of the University of Virginia School of Medicine and its Family Medicine Residency. She has worked in primary care and urgent care settings, and has taken additional training in Natural Family Planning and is a Certified FertilityCare Medical Consultant, working with women on issues like recurrent miscarriage, infertility and irregular cycles without use of IVF or hormonal contraception.

Shes been a practitioner for the APRN since 2015 and a member of the Heartbeat International Medical Advisory Council and the Heartbeat International Abortion Pill Reversal (APR) Advisory Team since 2019.

A native of Baltimore, Poehailos now makes her home in Charlottesville, Virginiawhere she embraced the challenge of raising four sons through Scouts, sports and band carpools while still maintaining a medical practice and volunteer life at her church.

For many years, Poehailos worked off and on as a volunteer for ThriVe Central Virginia. However, in early 2018 she moved into part-time employment, then became a full-time physician there in June of 2018which she says is an unusual arrangement for pregnancy resource centers, since medical directors are usually volunteers or part-time employees.

Acknowledging the significant step forward in faith it took for the centers to commit to offering her a full-time role, she says that although she was excited, she was also nervous about leaving the employer shed been with for 20 years.

I felt like I was leaving my security blanket, she said. It was a step of faith to leave that job, because I love family medicine and I love doing urgent care, but I just kind of felt the nudge from God.

However, in the midst of the transition, she learned that her former employer had decided to close his doorswhich meant she wouldve suddenly been out of a job if shed stayed.

So, God definitely took care of me, she said.

In this context, Poehailos says she can clearly see how God has used a variety of seemingly disparate skills and circumstances to guide her to her current role.

Noting that the four centers now offer STI testing and treatment, she said, Before I went to medical school, I was a medical technologist and did hospital lab work. The fact that I already had a good lab background helped us get that off the ground. And Im actually comfortable drawing blood because I worked in a blood bank for a while.

She says another much-needed skill shes developed in recent years is the ability to perform her own ultrasounds.

I did training in limited OB ultrasounds so I can conduct the scans myself, in addition to reading them, Poehailos said.

Citing Esther 4:14 as one of her favorite verses, she said, You know, this is the moment for which you've been created. I mean, why was I a med tech before I decided to go to medical school? Well, it finally became clear much later.

Poehailos says her journey to becoming an APRN provider started with a natural family planning meeting in Milwaukee in 2010. It was during lunch with two other physicians that she first heard about the use of progesterone after a woman took the first dose of the abortion pill to try to reverse the abortion.

I thought, Wow, that sounds really interesting, she said. But I didn't have that much familiarity with working with progesterone and I kind of filed the information away in my head.

It was a year or so later, Poehailos said, when she took the FertilityCare medical consultant course at the Saint Paul VI Institute in Omaha, and, one of the primary tools in our toolbox was to use progesterone for women with threatened miscarriage and women with certain cycle irregularities. Once I took that course and got comfortable with progesterone, I knew I was ready to join the APRN hotline as a provider.

When she first got involved, the APRN was operated by Dr. George Delgado through Culture of Life Family Services in San Diego. The APRNs operations transitioned to Heartbeat International in 2018.

Poehailos vividly remembers the first call she received in February of 2015. She was with one of her sons, visiting a university campus and walkway over Interstate 81 on a pedestrian bridge.

My phone vibrates in my pocket and I pull it out and theres a text that says, Hi, this is the hotline. We might have a patient for you, she recalled.

After telling her son to go to the next lecture without her, she found a spot in the lobby of a building and talked to the hotline nurse, then called the patient. When they returned to Charlottesville later that afternoon, Poehailos said, I met her at the office, and we started the protocol.

That first patient was also her first successful reversal; the healthy little girl who recently turned five.

Over time, her experiences have taught her how to prepare women regarding what to expect once the reversal process has startedwhich is an important part of helping them cope with everything thats going on in their lives.

We have to remember that whatever circumstances led the woman to start the medical abortionher social situation or whatever was an influencing factor in her decisiondoesn't magically go away when she attempts to rescue that abortion attempt, said Poehailos. So whatever else was stressing her with her family or her boyfriend or whatever is going on, we have to always remember when we're in contact with these women afterwards, that those things didn't magically disappear.

They are going to need more support than the average woman who may be threatening a miscarriage for another reason, she added.

As far as follow-up, she says she tries to stay in contact with women until they can receive care from a local obstetrician.

Our mission is to get them turned over to local OB care, Poehailos explained. I always tell them when I'm seeing them for the ultrasound that they need to get established with an OB physician and Ill be happy to share any needed information.

Poehailos says being an APRN provider has had a big impact on herespecially when she gets good news about how the moms and children have been thriving since her first contact with them.

One reached out to text me a couple of years ago on Mother's Day and said, Happy Mother's Day to you. And thank you. Here's a picture of my baby, said Poehailos. It just makes you want to cry.

She also recalled how five years ago when the first baby she helped was about to enter the world, the mom asked her to come to the hospital to meet the baby after she was born.

She wasnt that far from away from us, Poehailos said, so I was able to go to the hospital at her request, the day of the delivery to see the baby. The mom took a picture of me holding the baby the day she was born. That's a picture for forever.

Poehailos says one of the challenges with APR is the critical timing thats requiredsince the woman needs to be seen right away to start the protocol. Fortunately, the APRN providers help each other out, she said, providing creative support to meet patient needs.

There's nice collaboration between the providers on the network, Poehailos said. One way or another, weve always managed to get it done.

Referring to the APRN as the emergency room for pregnancy resource clinics, Poehailos said, Were like the code team in a hospital. You have to get there now.

Other times, when women come in and they're still considering all their options, it's not as urgent, she said. But with APR theres much more urgency since the process has already been started and we have to stop it. Somebody needs to be there pretty fast to get the ball rolling. We all pitch in to make sure that happens.

Tweet This: With Abortion Pill Rescue theres urgency as the process has been started & we have to stop it. We all pitch in to make sure that happens.

In terms of ongoing needs, Poehailos says she wants to spread the word about the APRNespecially to other providers who may want to become part of something that makes such a difference.

Theres a great need for more local providers, she says, so women who are already in crisis wont be required to travel long distances to access the urgent care thats required.

We have a lot of providers in the network, but were not evenly distributed geographically, Poehailos said.

And even if theres an APRN provider already in a specific area, Poehailos said it would be a big help to have more than one, so they could back each other up to meet local needs.

If one provider isnt available when a woman needs their services, it would be awesome to have another provider in that same city, said Poehailos, instead of making the woman drive several hours to receive care.

Poehailos says shes been grateful for the increased resources that became available when the Heartbeat International assumed oversight of the APRN.

The people who started APR did an amazing job to get the ball rolling, said Poehailos. Im grateful Heartbeat International was able to step in and put the strength of their network and Option Line behind the network, because we really needed that to have the increased reach.

If you are a woman in need of Abortion Pill Rescue care, representatives are available 24/7 through Option Line to speak with you. Click HERE, call 1-800-712-4357 or text HELPLINE to 313131.

If you are a healthcare provider interested in becoming part of the APRN, you can learn more by visiting the Abortion Pill Rescue Network page.

Editor's note: Heartbeat International manages the Abortion Pill Rescue Network, Option Line and pregnancy Help News.

Go here to see the original:
A nudge from God one doctor's journey to serving other women through Abortion Pill Rescue - Pregnancy Help News

For patients with hormone receptor (HR)positive, HER2-negative breast cancer, research reported that adding ribociclib (Kisqali) to endocrine therapy significantly improved overall survival (OS) while delaying subsequent chemotherapy when compared with placebo, regardless of endocrine partner, according to results presented during the 2020 San Antonio Breast Cancer Symposium.1

An updated analysis of the phase 3 MONALEESA-7 trial (NCT02278120) reported a median follow-up of 53.5 months (range, 46.9-66.4), and the median OS with ribociclib plus endocrine treatment was 58.7 months vs 48.0 months with placebo/endocrine therapy (HR, 0.763; 95% CI, 0.608-0.956), translating to a 24% relative reduction in the risk of death with the CDK4/6 inhibitor.

Moreover, data from a subgroup analysis examining survival in relation to endocrine partner, results showed that patients who received a nonsteroidal aromatase inhibitor (NSAI) experienced a median OS of 58.7 months with ribociclib/endocrine therapy vs 47.7 months with placebo/endocrine therapy (HR, 0.798; 95% CI, 0.615-1.04). In those who received tamoxifen, the median OS had not yet been reached with ribociclib vs 49.3 months with placebo (HR, 0.705; 95% CI, 0.453-1.097).

A consistent significant OS benefit with ribociclib plus endocrine therapy was demonstrated after a longer median follow-up of 53.5 months. With a median OS of 58.7 months in the ribociclib arm, this is the longest median OS [that we have seen] among the phase 3 trials for HR-positive, HER2-negative advanced breast cancer, Debu Tripathy, MD, professor and chairman of the Department of Breast Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, said in a poster presentation during the meeting. Therefore, this exploratory analysis confirms the benefit and continued use of ribociclib in the first-line setting for pre- or perimenopausal patients with HR-positive, HER2-negative advanced disease.

In the multicenter, double-blinded, placebo-controlled phase 3 MONALEESA-7 trial, investigators set out to evaluate the efficacy of ribociclib in pre- and perimenopausal patients with HR-positive, HER2-negative advanced breast cancer. To be eligible to participate, patients needed to have received at least 1 previous line of chemotherapy for advanced disease and they could not have been administered prior endocrine treatment.

A total of 672 patients were randomized 1:1 to receive either ribociclib at a daily dose of 600 mg 3-weeks-on/1-week-off (n = 335) or placebo (n = 337) in combination with goserelin plus either a NSAI or tamoxifen. The primary end point of the trial was progression-free survival (PFS), and key secondary end points comprised OS, health-related quality of life, overall response rate (ORR), time to definitive deterioration of the ECOG performance status, PFS2, and safety, among others.

Patient characteristics were found to be well balanced between the 2 treatment arms. The median age of participants in the investigational arm was 43 years.2 Moreover, 55.8% were white, 29.6% were Asian, and 8.7% were black, Native American, or other. The race of 6.0% of patients was unknown. The ECOG performance status of 73.1% of patients was 0; it was 1 in 26.0%, and unknown for the remaining 0.9%. More than half, or 57.6%, of patients had visceral metastases, with 24.2% of them having bone-only metastases.

Earlier data showed that ribociclib plus endocrine therapy was found to significantly improve PFS and OS compared with placebo/endocrine therapy in this patient population. Specifically, the median PFS was 23.8 months in the investigational arm vs 13.0 months in the control arm (HR, 0.55; 95% CI, 0.44-0.69; P < .0001).3,4 At a median follow-up of 34.6 months, the median OS reported in the final protocol-specified OS analysis had not yet been reached in the ribociclib arm vs 40.9 months in the placebo arm (HR, 0.71; 95% CI, 0.54-0.95; P = .00973).

After the prior analysis, patients were unblinded and 15 patients in the placebo arm crossed over to receive ribociclib, Amy S. Clark, MD, MSCE, assistant professor of medicine at the Hospital of the University of Pennsylvania, commented in a poster spotlight session during the meeting. The median OS had not been reached in the ribociclib group in that initial OS analysis, so I do think it was important to continue to follow these results.

Results from an exploratory subgroup analysis presented at the meeting proved to be consistent with the OS data reported for the overall patient population. However, investigators noted that this should be interpreted with caution because of the small numbers of patients, relatively wide confidence intervals, and a lack of statistical power, said Tripathy.

As of the June 29, 2020 data cutoff, 21.2% of patients on the ribociclib/endocrine therapy arm and 9.2% of those on the placebo arm were still receiving treatment. Almost 80% (78.8%) of patients on the investigative arm had ended treatment vs 90.8% of those on the control arm.

On the ribociclib arm, the majority of patients, or 62.7%, discontinued due to disease progression, noted Tripathy. Additionally, 6.3% of these patients discontinued due patient/guardian decision, 3.6% due to physician decision, 4.8% due to an adverse effect (AE), 0.9% due to death, and 0.6% were lost to follow-up.

Moreover, 77.3% of those on the ribociclib/endocrine therapy arm vs 78.1% of those on the placebo/endocrine therapy arm went on to receive subsequent therapy. The most common first subsequent therapies were chemotherapy alone and hormone therapy alone.

Subsequent treatments received in the investigative and control arms included chemotherapy (22.3% vs 28.4%, respectively), chemotherapy plus hormone therapy or other therapy (10.2% vs 10.1%), hormone therapy alone (27.7% vs 18.3%), hormone therapy plus other therapy (15.2% vs 18.0%), or other treatment (1.9% vs 3.3%).

Moreover, more patients on the placebo arm went on to receive a CDK4/6 inhibitor following treatment discontinuation. Almost 13% of patients on the investigative arm went on to receive another CDK4/6 inhibitor vs 26.1% of those on the control arm. Among the patients on the investigative arm, 9.5% received palbociclib (Ibrance), 2.3% received ribociclib, and 1.5% received abemaciclib (Verzenio). In the control arm, 21.9%, 3.9%, and 0.7% of patients received palbociclib, ribociclib, or abemaciclib, respectively.

The median time to chemotherapy was 50.9 months with ribociclib plus endocrine therapy vs 36.8 months with placebo plus endocrine therapy (HR, 0.694; 95% CI, 0.556-0.867). Moreover, the median chemotherapy-free survival in the investigative and control arms was 42.4 months vs 26.4 months, respectively (HR, 0.666; 95% CI, 0.550-0.808). Lastly, the median PFS2 with ribociclib was 44.2 months vs 31.0 months with placebo (HR, 0.683; 95% CI, 0.560-0.834).

The toxicities in the safety population proved to be consistent with those observed in the primary and final OS analyses, according to Tripathy. AEs of special interest in the ribociclib and placebo arms included all-grade neutropenia (77.9% vs 10.7%, respectively), leukopenia (35.5% vs 5.9%), anemia (22.7% vs 11.6%), hepatobiliary toxicity (29.3% vs 23.7%), QTc prolongation (12.8% vs 6.5%), and interstitial lung disease/pneumonitis (0.6% vs 0%, respectively).

The most commonly reported grade 3 or higher AE in the ribociclib arm was neutropenia (53.1%, grade 3; 11.6%, grade 4). In the control arm, hepatobiliary toxicity was the most frequently experienced grade 3 effect (6.8%), while neutropenia (0.9%) was the most common grade 4 toxicity.

The OS benefit of those receiving ribociclib and endocrine therapy, regardless of the endocrine therapy partner, was sustained in this longer-term follow-up, concluded Clark. The addition of ribociclib also lengthens time to chemotherapy and chemotherapy-free survival, which I think is an incredibly important outcome for these patients who live for many years and who would like to delay the time to chemotherapy for as long as possible. I believe that these data are continued evidence that ribociclib should be considered for use in pre- and perimenopausal women with newly diagnosed [estrogen receptor]positive metastatic breast cancer.

References:

1. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with endocrine therapy (ET) +/- ribociclib. Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-11, 2020; Virtual. Abstract PD2-04. https://bit.ly/33WH2ly.

2. Tripathy D, Im S-A, Colleoni M, et al. First-line ribociclib or placebo combined with goserelin and tamoxifen or a nonsteroidal aromatase inhibitor in premenopausal women with hormone receptorpositive, HER2-negative advanced breast cancer: results from the randomized phase 3 MONALEESA-7 trial. Presented at: 35th Annual Miami Breast Cancer Conference; March 8-11, 2018; Miami, FL. Abstract 626.

3. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904-915. doi:10.1016/S1470-2045(18)30292-4.

4. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316. doi:10.1056/NEJMoa1903765.

Excerpt from:
Significant Survival Benefit Found with Ribociclib to Treat HR+/HER2- Breast Cancer - Cancer Network

Imagine being a doctor and having a precocious resident permanently by your side, giving you brilliant insight into disease and helping you to identify the best treatment path for your patients.

A team at Salesforce Research believes this scenario is closer to reality than you might think, as a result of a series of exciting developments in AI vision technology and machine learning.

Breast cancer affects more than two million women worldwide each year, with around one in eight women in the United States developing breast cancer over the course of their lifetime. There were also 2,550 new cases of breast cancer in men in the U.S. in 2018. Alarmingly, rates of breast cancer are increasing in nearly every region globally.

Salesforce Research collaborated with the Ellison Institute to develop ReceptorNet, a deep-learning algorithm that can determine hormone-receptor status - a crucial biomarker for clinicians when deciding on the appropriate treatment path for breast cancer patients - with excellent sensitivity and specificity numbers. This work has been published in the journal Nature Communications under the title 'Deep learning-enabled breast cancer hormonal receptor status determination from base-level H&E stains.'

While using AI to try to improve outcomes for breast cancer patients is not new, efforts up until now - such as Google's AI breast cancer screening tool - have largely focused on diagnosing cancer.

What makes ReceptorNet unique is that it focuses on improving the way treatment decisions are made for breast cancer patients. Specifically, ReceptorNet predicts hormone-receptor status from an inexpensive and ubiquitous tissue image. That's in contrast to the current standard of care, which requires both a more expensive, less widely available type of tissue image - and a trained pathologist to review those images.

Crucially, because it is a less expensive and quicker way of determining hormone-receptor status than the system used commonly today in countries like the U.S., it could potentially help make high-quality decision-making for breast cancer therapies more accessible - allowing patients globally to receive the best possible treatment path, regardless of the expertise available in their healthcare system.

The development of ReceptorNet originated in conversations between Salesforce researchers and Dr. David Agus, Founding Director and CEO of the Lawrence J. Ellison Institute for Transformative Medicine of USC.

Dr. David Agus, Founding Director & CEO, Lawrence J. Elison Institute for Transformative Medicine of USC

Dr. Agus is a renowned oncologist and a professor of medicine and engineering. He explains that there has long been a belief among cancer doctors that tumor cells contain crucial information about cancer that the human brain can't quite extract.

'The human brain is very good at determining whether or not there is cancer based on looking at patterns in cells,' says Dr. Agus, 'but it can't determine the subtle differences in these patterns that correlate with the outcome of the cancer. In other words, what the molecular on/off switch is.'

This means that a patient might be diagnosed with cancer but then have to wait weeks for the results of molecular studies to determine what treatment they should receive.

'Our team has been working on using AI to understand patterns of cells and help make treatment decisions for several years. We had this notion that maybe we could find the answer to those molecular questions instantaneously with AI and machine learning,' Dr. Agus says.

That's where the Salesforce Research team came in. 'We have a world-class AI research team,' says Nikhil Naik, Lead Research Scientist at Salesforce Research and the first author on this study, adding that, 'the collaboration also matched our philosophy of developing technology that doesn't just serve the purpose of the company, but also has a positive impact on people and on the world.'

With a PhD in computer vision from MIT, Naik says he realized early on that Salesforce would be in an ideal position to help.

The algorithm is able to determine subtle patterns the human eye can't possibly perceive.

The team developed an AI solution that is able to extract vital clues about breast cancer by learning to spot patterns in images of tumors, using a cheap and widely available imaging process. Naik gives a simple analogy.

Say you have an accident and you think you may have broken your arm. What if, instead of having to go to the hospital for an X-ray, you could just take a photo of your arm on your cell phone and an AI algorithm could determine whether or not you had a fracture?

'That is very similar to what we are doing. We are replacing an expensive, time-consuming process that requires specialized technology with a simpler, more widely available technology for imaging, using artificial intelligence.'[MC(2]

So how does this work in practice? Typically, when a patient is diagnosed with breast cancer, a pathologist will analyze their tumor tissue under a microscope using a process called immunohistochemistry (IHC) staining, to look for the presence of hormone receptors that allow the cancer to grow. This helps them to decide on the best course of treatment, such as hormone therapy or chemotherapy.

The problem with IHC staining is that it is expensive, time-consuming, and not readily available in many parts of the world, particularly in developing countries.

ReceptorNet has learned to determine hormone receptor status by using a much less expensive and simpler imaging process - hematoxylin and eosin (H&E) staining - that analyzes the shape, size, and structure of cells.

ReceptorNet has been trained on several thousand H&E image slides, each containing billions of pixels, from cancer patients in dozens of hospitals across the world.

'The algorithm is able to look at individual pixels and determine subtle patterns that the human eye can't possibly perceive,' says Andre Esteva, Head of Medical AI, and co-author on the study, explaining that patterns can yield vital clues about how to treat the cancer.

An illustrative interpretation of how AI can spot what the human eye can't see

Since early 2019, Naik and Esteva have been leading a team at Salesforce that focuses on delivering AI applications for social good, primarily in the areas of medicine and science. Recently, the team created search engines for COVID-19 to help researchers and clinicians find information faster.

'There's a significant benefit to doing this kind of AI research in industry, as opposed to academia. AI teams tend to flourish when provided with industrial scale compute capabilities - and industrial scale budgets - because those elements make it much easier to rapidly experiment,' says Esteva.

'I think the most impactful applications of AI will be in healthcare,' adds Research Scientist Ali Madani, who assisted on the computer vision algorithm that powers ReceptorNet.

Madani talks passionately about the transformative impact AI could have on people's lives. 'There are direct applications that could improve society as a whole,' he says. 'That's the underlying motivation which has drawn me to AI and healthcare.'

An algorithm that's only 80% accurate is not good enough for a critical application, like determining which cancer therapy to give to a patient.

So, what could this mean for clinicians and patients? The ability to determine hormone-receptor status from H&E stains could make treatment less expensive and more readily available, particularly in developing countries.

It could also, says Dr. Agus, mean patients are spared an agonizing wait between diagnosis and the initiation of treatment.

Proposing a future use case of this new technology, Dr. Agus said to, 'Imagine when a woman comes in for her diagnosis and we can tell her right there on the spot what her treatment should be. Or in a third-world country (where molecule tests aren't available), imagine potentially being able to, just by scanning a slide, tell a woman that she can get a pill that could put her breast cancer under control. All of a sudden there's a transformation in medicine.'

In order for AI in medicine to deliver its full potential, clinicians must first have confidence in its accuracy.

'An algorithm that's only 80% accurate is not good enough for a critical application, like determining which cancer therapy to give to a patient,' acknowledges Naik.

In the test phase of the ReceptorNet project, when the algorithm was tested on images it had never seen before, it achieved 92% accuracy for hormone receptor determinations, which indicates its potential for future clinical deployment.

Numerous small, incremental changes were made to ensure the algorithm was able to deliver accurate predictions, regardless of differences in the preparation of the tissue samples it was analyzing. Crucially, the algorithm has also been able to deliver reliable performance across different demographic groups.

There have long been concerns that healthcare and evidence-based medicine can be biased against certain groups, because they are often underrepresented in the evidence base. However, during the development of ReceptorNet, researchers were able to achieve accurate results across a variety of different groups, which could be vital in order to build confidence in the performance of the AI among healthcare professionals.

Naik says, 'We analyzed this by splitting the data based on things like age, race, and location, and statistically there was no difference in the performance of the algorithm.'

Throughout the design process, the Salesforce team worked closely with Dr. Agus, Dr. Dan Ruderman, and Dr. Michael F. Press at The Ellison Institute, to ensure they were aware of any possible biases that could exist in the data that was fed into the model. This close collaboration also helped to ensure that the objectives of the team were closely aligned with the clinical workflows and questions that clinicians, doctors, and nurses would be interested in.

Despite this, the team was aware that not every medical professional would be easily convinced that AI could be relied upon.

Naik says that the pathologists they spoke to were initially skeptical, explaining that this kind of prediction based on an H&E slide is not something pathologists could do on their own.

'However, when they saw that the algorithm was working so well, they were really impressed that it was able to make these predictions just by learning from thousands of images - and also that it was able to confirm their suspicions about what kinds of patterns could be predictive. That was very impressive and exciting for them.'

Dr. Agus agrees. 'When we first started looking at how we could answer molecular questions instantaneously with AI and machine learning, we achieved some good results. But when we teamed up with Salesforce, those results went from good to great.'

But when we teamed up with Salesforce, those results went from good to great.

From a clinical perspective, this technology could eventually lead to a number of positive impacts. In a developed country such as the U.S., it could reduce the cost of care and the time it takes to initiate breast cancer treatment, because it uses much less expensive imaging technology and automated decision-making. It could also improve accuracy and deliver better outcomes for patients.

In developing countries where there is limited access to IHC staining, it could have a big impact in terms of broadening access to treatment.

The immediate effect of this work is to lay a foundation for future studies to compare the clinical workflow of a pathologist with and without this type of AI, in order to better understand its full potential.

Dr. Agus says that, 'This is just the tip of the iceberg with what we're going to be able to do with AI in cancer care. It's just a pilot project to show what's doable. Now, we can get deeper and deeper, and I can envisage a day not too far away, when just by looking at a slide, I can tell, with the help of AI, tell somebody 'you're going to get Drug X and not Drug Y because of how the cells are arranged'.'

For Esteva, one of the most exciting things about this project is that it has shown how AI can do more than just mimic the role of a doctor.

'What we're doing here is actually training AI to do something that the physician can't do, as an added capability to their repertoire. The AI can see patterns that are essentially invisible to the physician, and potentially critical for the patient.'

AI could ultimately also have a positive impact on the doctor-patient relationship. With access to AI-powered insights, doctors could have more informed conversations with their patients at an early stage in their treatment path, giving them a fuller, data-driven picture of what may lie ahead in terms of treatment and therapy.

What gets me really excited is thinking, 'where is this going to go in the next five or 10 years?'

Esteva is keen to stress that AI will help augment the role of a doctor, not replace it.

'What gets me really excited is thinking, 'where is this going to go in the next five or 10 years?' Unfortunately, many of us can relate to situations where someone we love was given the wrong therapy or misdiagnosed. You end up asking yourself how their lives could have been different if a slightly better decision was made. A single moment can have a ripple effect in a patient's life for years or decades.'

'Physicians should be able to make the best possible decisions based on all available medical knowledge. If you can build AI that can help doctors make the right decisions, by harnessing the collective intelligence of physicians and medical data, that's incredibly powerful.'

Dr. Agus adds, 'AI and machine learning are going to herald a new era, with potential to be applied to diseases beyond cancer and ultimately create better outcomes for patients. It won't happen overnight, and it will be a slow, step-by-step process, but we're embarking on a journey over the next decade to improve every aspect of what we do, through data. That's really exciting.'

Disclaimer

salesforce.com Inc. published this content on 10 December 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 December 2020 16:20:03 UTC

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AI at Work: How Salesforce AI Could Make Therapeutic Decision-Making for Breast Cancer More Accurate, Affordable and Accessible - marketscreener.com

Pune, India, Dec. 10, 2020 (GLOBE NEWSWIRE) -- The global heparin market size is expected to reach USD 11.43 billion by 2027, exhibiting a CAGR of 3.9% during the forecast period. The market size stood at USD 8.39 billion in 2019. The increasing cases of cardiovascular diseases such as deep vein thrombosis & pulmonary embolism are expected to spur demand for heparin in the forthcoming years, states Fortune Business Insights, in a report. The market size in North America stood at USD 4.28 billion in 2019. The growth in the region is attributed to the prevalence of cardiovascular diseases such as pulmonary embolism. The higher adoption of advanced heparin products will have an excellent effect on the market in the region.

Key Development:

May 2019: Pfizer, Inc. announced that it has received the approval from the U.S. FDA for the administration of its heparin product offering, Fragmin to minimize the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged one month and above.

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Rising Incidence of Chronic Disorders to Incite Business Development

The increasing prevalence of cardiovascular diseases around the world, including heart attacks and strokes will spur opportunities for the market. As per the American Heart Association (AHA) Heart Disease and Stroke Statistics, an estimated 5.3 million Americans suffered from atrial fibrillation in 2019.

The growing demand for heparin among patients can have an excellent impact on the market. As per the Centers for Disease Control and Prevention, coronary heart disease is the most common type of heart disease, killing 365,914 people in 2017.4. About18.2 million adultsage 20 and older have CAD (about 6.7%). Moreover, 2 in 10 deaths from CAD happen in adults less than 65 years old. The increasing awareness about the benefits of heparin in the treatment and management of heart diseases will improve the prospects of the market in the foreseeable future.

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Minimal Impact on the Market During COVID-19

The limitations on non-essential medical procedures and consultations has had a drastic impact on the global market amid COVID-19. The healthcare industry has observed a decline in other medical services besides coronavirus. The increased emphasis on COVIDs vaccine has reduced the demand for other therapeutics.

Furthermore, the lack of supply and production of heparin will simultaneously limit the scope of the market. However, government initiatives, including heavy investments and free medical aid will influence the healthy growth of the market in the time of the pandemic.

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High Adoption of Advanced Products to Boost Market in North America

The market size in North America stood at USD 4.28 billion in 2019. The growth in the region is attributed to the prevalence of cardiovascular diseases such as pulmonary embolism. The higher adoption of advanced heparin products will have an excellent effect on the market in the region.

The increasing healthcare expenditure is expected to foster the healthy growth of the market in North America. The presence of major companies can further enhance the development of the market in the region. Europe is expected to hold the largest share owing to the acceptance of technologically advanced products in the region. The rising number of patients suffering from a range of cardiovascular diseases will further spur opportunities in the region.

Asia Pacific is expected to experience a rapid growth rate owing to the growing patient population. The surging healthcare expenditure in the developing nations will have a tremendous effect on the market in Asia Pacific.

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Heparin Market to Hit USD 11.43 Billion with a CAGR of 3.9% by 2027; Rising Prevalence of Chronic Diseases to Propel Business, states Fortune Business...

Dublin, Dec. 08, 2020 (GLOBE NEWSWIRE) -- The "Prostate Cancer Disease Coverage Forecast and Market Analysis to 2036" report has been added to ResearchAndMarkets.com's offering.

Newly approved therapies for castration-resistant prostate cancer are set to create a shift in the way that the disease is treated, while creating a competitive environment for new market entrants.

Latest Key Takeaways

The report estimates that in 2018, there were 1.3 million incident cases of prostate cancer worldwide in males aged 40 years and older, and forecasts that number to increase to 1.5 million cases by 2027.

In the US, prostate cancer is the most common non-cutaneous malignancy diagnosed in men, and is the second-leading cause of cancer mortality in men behind lung cancer.

The overall likelihood of approval of a Phase I prostate cancer asset is 4.9%, and the average probability a drug advances from Phase III is 51.5%. Prostate cancer drugs, on average, take 9.0 years from Phase I to approval, compared to 9.5 years in the overall oncology space.

Pfizer's next-generation androgen receptor (AR) inhibitor Xtandi is the market leader in prostate cancer due to its established efficacy across prostate cancer segmentations and a lack of near-term generic competition. Bolstered by recent and planned expansions into additional prostate cancer segments, Xtandi will continue to be the leading option in this indication. Future expansion opportunities include potential use in combination with PARP inhibitors Talzenna or Rubraca in metastatic castration-resistant prostate cancer (mCRPC) patients.

Xtandi is also being trialed in combination with leuprolide in the Phase III EMBARK study for non-metastatic hormone-sensitive prostate cancer patients progressing on definitive therapy. Potential expansion into this segment represents a significant opportunity to improve outcomes earlier in the treatment paradigm, but the combination will have to demonstrate a significant benefit over existing localized treatment options to justify the additional clinical and financial toxicity of Xtandi treatment.

Since the launch of generic abiraterone in the US in November 2018, sales of Johnson & Johnson's cytochrome P450c17 inhibitor Zytiga have begun to erode. Further generic erosion is expected in the EU and Japanese markets in the next few years, decimating sales of the multi-blockbuster. Although branded Zytiga will continue to decrease in market share, use of abiraterone as part of standard regimens will continue and may expand to include several novel combinations.

The PARP inhibitors Rubraca and Lynparza were both approved in the US in May 2020 for the treatment of mCRPC patients following AR inhibitor therapy. Rubraca received accelerated conditional approval in mCRPC with a deleterious BRCA mutation (germline and/or somatic), while Lynparza received full approval for use in the broader homologous recombination deficient (HRD) population. To potentially differentiate the PARP assets, both are being trialed in the first-line setting of mCRPC; Rubraca in combination with Xtandi against Xtandi alone, and Lynparza with abiraterone against abiraterone alone. There is potential synergy with these combinations as its hypothesized that AR inhibitors may sensitize tumors to PARP treatment by reducing DNA damage repair (DDR) expression.

Late-phase PARP inhibitors Zejula and Talzenna are also being developed in combination with next-generation treatments and will join a crowded PARP treatment space. Zejula is being tested in combination with abiraterone against abiraterone alone as first-line therapy for mCRPC patients. Similarly, Talzenna is being studied in combination with physician's choice of Xtandi or enzalutamide in mCRPC patients, also as a first-line option. The potential synergy of the PARP inhibitors with AR modulators is promising, but a strong benefit will have to be seen to justify use in the front-line setting of mCRPC. If approved, it is likely that these regimens will be limited to the HRD or even BRCA populations, where they will have strong utility but somewhat limited commercial impact due to the relatively small prevalence of these biomarkers.

Next-generation AR inhibitors Nubeqa and Erleada have shifted the treatment paradigm to include these therapies in earlier segments of disease such as non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Expansion into earlier segments and lines of therapy is ongoing. Bayer is looking to expand Nubeqa's label to include use in very high-risk localized patients and metastatic hormone-sensitive patients. Johnson & Johnson will continue to try and differentiate Erleada with an aggressive development plan that includes potential expansions into chemotherapy-naive mCRPC patients as part of a combination with abiraterone, as well as into the localized setting for patients treated with prostatectomy or radiation therapy.

Akt inhibitors ipatasertib and capivasertib are a potential new mechanistic addition to the prostate cancer space, but the efficacy/tolerability profile of these PI3K/Akt/mTOR pathway inhibitors may prevent approval and potential usage. Ipatasertib is a pan-Akt inhibitor from Roche currently in development for asymptomatic or mildly symptomatic mCRPC patients with PTEN loss as part of a combination with abiraterone. PTEN loss is not a standard target in this indication, but represents a significant market opportunity as it is estimated to occur in approximately 20% of primary prostate cancers and up to 50% of castration-resistant tumors. However, ipatasertib is beset by known class toxicities of PI3K/Akt/mTOR pathway inhibitors such as diarrhea, rash, and ALT/AST elevations that could be detrimental to its regulatory chances. AstraZeneca's Akt inhibitor capivasertib has also demonstrated mixed results in prostate cancer.

In the Phase I/II ProCAID trial, capivasertib in combination with docetaxel failed to meet the primary endpoint of improved progression-free survival in mCRPC patients. However, the combination did improve overall survival in these patients irrespective of PI3K/Akt/mTOR pathway mutations. This has led to initiation of the Phase III CAPItello-281 trial testing capivasertib in combination with abiraterone in de novo mHSPC with PTEN loss.

Several checkpoint inhibitors are in development for prostate cancer, but late-phase data from ongoing combination trials are needed to fully determine their relative outlook in the indication. Merck is pursuing an aggressive late-phase development strategy for Keytruda in prostate cancer that includes combinations with Lynparza, Xtandi, and docetaxel for the treatment of mCRPC patients. Opdivo is also in late-phase development as part of a combination with docetaxel in mCRPC patients after failure on a next-generation hormone therapy. Finally, Roche's Tecentriq, the lone anti-PD-L1 antibody in late-phase development for prostate cancer, is currently in Phase III development in combination with Xtandi or in combination with Cabometyx in mCRPC patients after failing on a next-generation hormone therapy.

Myovant's relugolix is a GnRH receptor antagonist that is differentiated from available GnRH antagonist Firmagon by its oral formulation, which will facilitate use in patients undergoing localized definitive therapy who also need ADT and may also allow use of an intermittent ADT option in advanced hormone-sensitive patients looking to mitigate side effects and maintain quality of life.

Key Topics Covered:

OVERVIEW

DISEASE BACKGROUND

TREATMENT

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

CLINICAL TRIAL LANDSCAPE

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

BIBLIOGRAPHY

APPENDIX

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Global Prostate Cancer Disease Coverage Forecast and Market Analysis 2020-2036 - Xtandi will Remain the Best-selling Therapy Over the Next Decade -...

Autologous hematopoietic stem cell transplant (AHSCT) induces a reduction in relapse rate and physical disability in patients with relapsing-remitting multiple sclerosis (RRMS) who respond inadequately to other treatments, a small study suggests.

The study, Selective cognitive dysfunction and physical disability improvement after autologous hematopoietic stem cell transplantation in highly active multiple sclerosis, was published in the journal Nature Scientific Reports.

AHSCT is an experimental approach to treat multiple sclerosis (MS) that is meant to rebuild a patients immune system in order to stop attacks on the brain and spinal cord.

The procedure begins with collecting a patients own (meaning autologous) healthy hematopoietic stem cells immature cells that can develop into all types of blood cells from the bone marrow. These cells are put back into the patient after a fairly non-aggressive combination of chemotherapy is given to kill the patients immune cells.

A team of researchers at the Vilnius University, in Lithuania, evaluated the effectiveness and safety of the AHSCT procedure in 24 patients (18 female, mean age 37.8 years) with highly active RRMS (mean disease duration of 8.6 years) who failed to respond to conventional therapies.

The aim of the study was to assess cognitive dysfunction and physical disability after AHSCT, to explore the potential factors influencing disability regression after the transplant, and to estimate the safety of low-dose immunosuppressive therapy in highly active relapsing MS patients.

Researchers assessed participants disability and cognition through changes in several functional measures, including the expanded disability status scale (EDSS) and the Brief International Cognitive Assessment for MS, which includes three cognitive domains measured by the symbol digit modalities test, brief visuospatial memory test revised, and California verbal learning test second edition.

Of the 24 patients, 13 (54.2%) completed a 24-month follow-up and were included in the efficacy analysis of AHSCT. From those, two (15.4%) had one relapse during the first year after AHSCT and three patients (23.1%) had one relapse during the second year after AHSCT.

The annualized relapse rate (ARR) was 2.7 one year before AHSCT and 1.9 at two years before AHSCT. After the AHSCT procedure, ARR dropped to 0.2 in the first year and to 0.3 in the second year. This represented an 89% reduction in ARR, when comparing the values at two years after AHSCT with those at two years before AHSCT.

The researchers also noted a reduction in disability progression (as measured by EDSS scores), with 84.6% of patients improving their disability score after AHSCT at month six and 76.9% at one year. Additionally, 76.9% of patients showed stable disability scores two years after the transplant.

The findings of EDSS improvement in almost 85% of the patients suggest that disability may be often at least temporarily reversible in patients with highly active [relapsing] MS if they receive suitable and well-timed treatment, the researchers wrote.

Using appropriate statistical models, researchers found that the clinical variable that explained the disability regression at months 6 and 12 after AHSCT was the disability progression over 6 months before AHSCT.

Improvements in cognition after AHSCT also were observed. Specifically, the scores of information processing speed and verbal learning, measured by the symbol digit modalities test, were significantly higher at month 12 after AHSCT (56.8) when compared to month three (48.3).

The score of brief visuospatial memory test revised that assesses visuospatial memory was slightly lower at month three (25.6) than before AHSCT (27.8), however, the difference was not significant.

The score of the California verbal learning test, which assesses verbal learning, was significantly higher at month 12 (63.6) than before AHSCT (55.2).

No new or active lesions were found on MRI after AHSCT, suggesting that all patients remained without radiological disease activity.

Furthermore, regarding safety, the incidence and severity of adverse events (side effects) after AHSCT were in the expected range and all were resolved. There were no transplant-related deaths reported.

Researchers noted several limitations to the studys findings, including the low sample size and the fact that the patientss assessment and follow-ups were provided at the same center without a comparative group.

Nonetheless, the outcomes are highly promising, as compared to conventional MS treatment, the researchers wrote. Further research is needed to replicate these findings and to assess long-term outcomes and safety of AHSCT.

Diana holds a PhD in Biomedical Sciences, with specialization in genetics, from Universidade Nova de Lisboa, Portugal. Her work has been focused on enzyme function, human genetics and drug metabolism.

Total Posts: 1,053

Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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Stem Cell Transplant Reduces Relapses and Disability in RRMS... - Multiple Sclerosis News Today

Our goal with omidubicel is to revolutionize the field of bone marrow transplantation and bring a potentially curative cell therapy option to thousands of patients who are in need of a bone marrow transplant, but lack a suitable stem cell donor. These results bring us one step closer towards that goal, said Julian Adams, Ph.D., chief executive officer of Gamida Cell. Whats more, transplantation with omidubicel has been shown to result in more rapid neutrophil engraftment, a decrease in the amount of time patients spend in hospital, and a reduction in infections. These are very meaningful outcomes for patients and may also lessen the financial costs of certain aspects of the transplant.

Gamida Cell previously reported top-line data for omidubicel. In October, the company reported that the omidubicel phase 3 study achieved its secondary endpoints, analyzed in all randomized patients (intent-to-treat). In May, Gamida Cell reported that the study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patients recovery from a bone marrow transplant.

These pivotal data form the basis of a Biologics License Application (BLA) that Gamida Cell expects to initiate on a rolling basis before the end of this year. Gamida Cell is preparing to be launch ready in anticipation of potential FDA approval as early as the fourth quarter of 2021, subject to ongoing FDA discussions on manufacturing, quality and other matters.

The live event will be available here. More information about the Phase 3 study of omidubicel and the other updates included in this release can be found in the Pipeline Deep Dive presentation on the Gamida Cell website immediately following the event.

Details of Phase 3 Endpoints

As previously reported, Gamida Cell achieved positive topline results from its Phase 3 clinical study evaluating the safety and efficacy of omidubicel. The median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001). Neutrophil engraftment is a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells, and rapid neutrophil engraftment has been associated with fewer infections and shorter hospitalizations.

Today, Gamida Cell announced the details of achieving all three of the prespecified secondary endpoints of the study, analyzed in all randomized patients (intent-to-treat). These secondary endpoints were the proportion of patients who achieved platelet engraftment by day 42, the proportion of patients with grade 2 or grade 3 bacterial or invasive fungal infections in the first 100 days following transplant, and the number of days alive and out of the hospital in the first 100 days following transplant. All three secondary endpoints demonstrated statistical significance in an intent-to-treat analysis.

Additionally, Gamida Cell reported that the exploratory endpoints in the study demonstrated a reduction in the cumulative incidence of viral infections.

The international, multi-center, randomized Phase 3 study for omidubicel was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.

The company anticipates reporting the full data set in a peer-reviewed setting in the first half of 2021.

Commercial Readiness

The company discussed the market potential for omidubicel and launch plans. These included quantifying the market opportunity and keys aspects for a successful launch.

As it prepares for the potential commercial launch of omidubicel, the company also announced plans for the Gamida Cell Assist program, which has been designed to focus on patient access and support of every individual and their caregiver at each step of the transplant process. Once the program is launched, the Gamida Cell Assist case management team would provide a consistent, single point of contact for patients and health care professionals. This team would work with the transplant center to track each individual patients omidubicel therapy and provide real-time updates on the status of the therapy. Gamida Cell Assist is also designed to provide additional services, including coverage and reimbursement support, and patient and caregiver support, which may include financial, travel, and lodging assistance.

At Gamida Cell we are inspired to cure, with the goal of pioneering new standards of care for patients with blood cancers and serious blood diseases, said Michele Korfin, chief operating and chief commercial officer of Gamida Cell. The transplant process can be challenging and complex for the patient, caregivers and the entire transplant care team. As we prepare for commercialization, we have developed Gamida Cell Assist to serve as a comprehensive support program to focus on assuring a positive patient experience with omidubicel. We are committed to supporting patients and their caregivers during every step of their journey and enabling what matters most, a successful clinical outcome that makes a meaningful difference for patients.

Update on Natural Killer Cell Therapy GDA-201

In an oral presentation at the recent American Society of Hematology (ASH) 62nd Annual Meeting, it was shown that GDA-201 was well tolerated and no dose limiting toxicities were observed in the Phase 1 clinical study. GDA-201 demonstrated significant clinical activity in patients with non-Hodgkin lymphoma, with 13 complete responses and one partial response observed in 19 patients, for a response rate of 74 percent. Full details of the presentation can be found in the press release.

Phase 2 Study of Omidubicel in Patients with Severe Aplastic Anemia

In a poster presentation at ASH, it was shown that patients with severe aplastic anemia treated with omidubicel achieved sustained early engraftment. These data, which were presented on December 5 by Mohamed Samour, M.D., Hematology Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, are the first evidence that omidubicel can result in rapid engraftment and can achieve sustained hematopoiesis in patients who are at high risk for graft failure with conventional umbilical cord blood transplant.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.12 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit http://www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the U.S. Food and Drug Administration or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.3 For more information on the clinical study of GDA-201, please visit http://www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy has not been established by the U.S. Food and Drug Administration or any other health authority.

About the NAM Therapeutic Platform

Gamida Cells proprietary NAM-based cell expansion platform is designed to enhance the number and functionality of donor cells in culture, enabling the creation of potentially transformative therapies that move beyond what is possible with existing approaches. The NAM therapeutic platform leverages the unique properties of nicotinamide to enable the expansion of multiple cell types including stem cells and natural killer (NK) cells with appropriate growth factors to maintain the cells' original phenotype and potency. This can enable the administration of a therapeutic dose of cells with the potential to improve patient outcomes.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of and data reported from the clinical trials of Gamida Cells product candidates, anticipated regulatory filings, launch readiness and FDA approval, commercialization efforts and Gamida Cells expectations regarding its projected ongoing operating activities, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on February 26, 2020, its Reports on Form 6-K filed with the SEC on May 18, 2020, August 11, 2020 and November 10, 2020, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

______________________1 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al. Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374.2 Gamida Cell press release, Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies, issued May 12, 2020. Last accessed August 31, 2020.3 Clinicaltrials.gov identifier NCT03019666

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Gamida Cell Provides Pipeline Update, Including Detailed Results of Pivotal Phase 3 Clinical Study of Omidubicel, and Prepares to Start BLA Submission...

GROUNDBREAKING trial using stem cells on children with acquired brain injuries to begin in Madrid

Three children with an acquired brain injury (ABI) are set to take part in a pioneering stem cell trial that aims to improve their quality of life. Three neurologists at the Nio Jess Hospital in Madrid, the only public hospital in the country which has a dedicated unit for children with ABI, have had real success in using stem cell therapy in adults.

One of the children taking part in the trial in February 2021 is ten-year-old Bruno, who suffered inflammation in the brain when he was four-and-a-half years old that led to him being diagnosed with locked-in syndrome.

The children will begin by receiving an infusion of stem cells through n=bone marrow, which Brunos father hopes will change his boys life.

The doctors are very cautious, they believe that it will give him quality of life and we are going to notice it a lot, he said.

El Nio Jess is the only hospital doing something for acquired brain damage. We are pioneers.And the dream is that this trial becomes a drug, said Brunos mom Macarena

________________________________________________________________________

Thank you for taking the time to read this news article Groundbreaking Trial On Children With Brain Injuries In Madrid. For more UK daily news, Spanish daily news and Global news stories, visit the Euro Weekly News home page.

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Groundbreaking Trial On Children With Brain Injuries In Madrid - Euro Weekly News

- Lower rates of non-relapse transplant related mortality, sepsis, infections, and mucositis reported in patients receiving Iomab-B compared to patients on the control arm receiving salvage therapies

- Iomab-B enables high amounts of radiation to be delivered to the bone marrow to achieve targeted myeloablation

NEW YORK, Dec. 7, 2020 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") today announced that safety data from its ongoing pivotal Phase 3 SIERRA trial of Iomab-B in patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML) were presented at the 2020 American Society of Hematology (ASH) annual meeting. The oral presentation highlighted Iomab-B's targeting ability and corresponding safety data from 110 patients from the SIERRA trial for which detailed safety data was available. Iomab-B targets CD45, an antigen expressed on leukemia and lymphoma cancer cells and immune cells including bone marrow stem cells but not cells outside of the blood forming or hematopoietic system. This allows high amounts of radiation to be delivered to the bone marrow via Iomab-B while sparing healthy organs. As a result, statistically significant lower rates of sepsis were reported as well as lower rates of febrile neutropenia, mucositis and non-relapse transplant related mortality in patients receiving Iomab-B and bone marrow transplant (BMT) compared to patients that received salvage therapy and a BMT. In addition, patients that crossed over to receive Iomab-B and went to BMT after receiving salvage therapy but not achieving a complete response also had lower rates of sepsis, febrile neutropenia, mucositis and non-relapse transplant related mortality.

Dr. Mark Berger, Actinium's Chief Medical Officer, commented, "We are pleased that the engraftment and safety profile of Iomab-B remains positive and consistent with prior interim safety results at 75% of patient enrollment in SIERRA and also consistent with the large body of historical data from Iomab-B. Collectively, this data gives excitement as we approach the upcoming ad hoc interim analysis for SIERRA that will be completed by year-end and the ultimate potential of Iomab-B for patients with R/R AML and other blood cancers as a targeted conditioning regimen."

Story continues

Safety data presented in ASH oral presentation are highlighted in the table below:

ASH Oral Presentation: High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia

Adverse Event

Received Iomab-B/HCT (N=47)1% (N)

No CR Crossed over to Iomab-B/HCT (N=30)2 % (N)

Achieved CR and received Std HCT (N=9) % (N)

Sepsis

4.3 (2)

22.2 (6)

33.3 (3)

Febrile Neutropenia Gr 3-4

34.8 (16)

40.7 (11)

55.6 (5)

Mucositis Gr 3-4

10.9 (5)

18.5 (5)

33.3 (3)

Day +100 Non-Relapse Mortality3

2/45

(4.4%)

3/26

(11.5%)

2/9

(22.2%)

1 Adverse Event data available for 46 of 47 evaluable patients

2 Adverse Event data available for 27 of 30 evaluable patients

3 Iomab-B arm: 4 patients unevaluable. Conventional Care Arm: 4 patients unevaluable

Patient Group

No. of Patients

Radiation dose delivered to the Marrow. Median (range)

Radiation dose to GI tract. Median (range)

Iomab-B

47

14.9 Gy

(4.6-32)

2.8 Gy

(1.6-6.7)

Vijay Reddy, Vice President, Clinical Development and Head of BMT, "The targeted nature of Iomab-B makes it highly differentiated from current BMT conditioning regimens that are largely comprised of non-targeted cytotoxic chemotherapies. These data from SIERRA showing higher rates of sepsis, neutropenia and mucositis in patients receiving chemotherapy are consistent with the literature and unfortunately what we expected but hope to address with Iomab-B. Particularly, chemotherapy's effect on the GI tract and resulting mucositis, which we believe is leading to the higher rates of sepsis seen in the control arm. We are highly encouraged by the lower rates of adverse events and the universal engraftment reported from SIERRA and excited for the potential of targeted conditioning could have an BMT access, patient outcomes and quality of life."

About Iomab-B

Iomab-B (I-131 apamistamab) via the monoclonal antibody apamistamab, targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, B cells and stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once attached to its target cells emits energy that travels about 100 cell lengths, destroying a patient's cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient's cancer and marrow cells.

Iomab-B is currently being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. The SIERRA trial is being conducted at preeminent transplant centers in the U.S. with the primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival at one year. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Additional information on the Company's Phase 3 clinical trial in R/R can be found at http://www.sierratrial.com.

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. More information on this Phase 3 clinical trial can be found at http://www.sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell therapy and in a Phase 1/2 anti-HIV stem cell gene therapy with UC Davis. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 130 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: http://www.actiniumpharma.com

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Contacts:

Investors:Clayton Robertson Actinium Pharmaceuticals, Inc. crobertson@actiniumpharma.com

Hans Vitzthum LifeSci Advisors, LLCHans@LifeSciAdvisors.com(617) 430-7578

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SOURCE Actinium Pharmaceuticals, Inc.

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Actinium Highlights Iomab-B Safety Data Presented at the 62nd American Society of Hematology Annual Meeting - Yahoo Finance

Flotetuzumab was found to demonstrate antileukemic activity in patients with primary induction failure (PIF) and early-relapse acute myeloid leukemia (ER-AML), and the treatment appears tolerable with infrequent neurologic adverse events, according to results from an updated analysis of an ongoing open-label phase 1/2 study (ClinicalTrials.gov Identifier: NCT02152956). The preliminary findings were presented by Ibrahim Aldoss, MD, of the Gehr Family Center for Leukemia Research at City of Hope in Duarte, California, at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

CD123 is overexpressed on AML cells, including leukemia stem cells, as well as other hematological malignancies, said Dr Aldoss. Flotetuzumab is a humanized CD3 x CD123 bispecific T-cell engager that redirects T cells to kill tumor cells expressing CD123.

The open-label, single-arm, multicenter, phase 1/2 study previously identified the recommended phase 2 dosage of flotetuzumab as 500 ng/kg/d administered via continuous infusion in 28-day cycles following a step-up lead-in dose administered during cycle 1 in week 1 of treatment. The primary objective of the study was to assess safety and antileukemic activity of flotetuzumab in patients with PIF/ER-AML.

A total of 44 patients (PIF, n= 27; ER-AML, n=17) were included in the study. Median patient age was 63.5 years (range, 28.0-81.0), and most patient were men (70.5%). According to the European LeukemiaNet (ELN) 2017 risk stratification criteria, the majority of patients had nonfavorable risk (97.7%).

Evidence of antileukemic activity was documented in 59.1% of patients, with a median decrease of 81.0% in bone marrow blasts. Median time to first response was 1 cycle (range, 1-3).

The combined complete response rate (CR, <5% bone marrow blast) and CR with partial hematologic recovery (CRh) was 25.0% (PIF, 33.3%; ER-AML, 11.8%) and 31.8% when including CR with incomplete hematologic recovery (CRi). Among the 14 patients with CR/CRh/CRi, 8 patients subsequently underwent stem cell transplantation.

In addition, morphologic leukemia-free state was reported in 3 patients (PIF, n=1; ER-AML, n=2). Of the 10 patients with TP53 mutation, 5 were reported to have CRR/CRh/CRi, and 3 of those patients (60.0%) underwent stem cell transplantation.

For all patients who achieved CR/CRh/CRi, median duration of response was 8.13 months, and median overall survival was 10.7 months.

Cytokine release syndrome (CRS), the most frequently reported treatment-related adverse event, occurred in 100% of patients (n=44; all grade). One grade 3 CRS event occurred. Approximately half of CRS events (52%) occurred during step-up dosing in the first week of treatment, and the incidence of CRS progressively decreased over time.

Neurologic adverse events were reported as infrequent and of mild to moderate severity (all-grade headache, n=13; 29.5%). Neurologic treatment-related adverse events of grade 3 or more were confusional state (n=3) and dizziness (n=1).

Flotetuzumab demonstrated encouraging activity in patients with primary induction failure in early-relapse AML, a population with poor prognosis and high unmet medical need, Dr Aldoss concluded.

The study (ClinicalTrials.gov Identifier: NCT02152956) is currently enrolling patients.

Disclosure: Some authors have declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.

Read more ofHematology Advisorscoverage of the ASH 2020 meeting by visiting theconference page.

Aldoss I, Uy G, Vey N, et al. Flotetuzumab as salvage therapy for primary induction failure and early relapse acute myeloid leukemia. Presented at: American Society of Hematology (ASH) 62nd Annual Meeting and Exposition; December 5-8, 2020. Abstract 331.

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Antileukemic Activity Seen With Flotetuzumab in Primary Induction Failure, Early-Relapse AML - Hematology Advisor

Korean medical professionals have discovered a method to resolve postoperative complications of hematopoietic stem cell transplants (HSCT).

A team of researchers from Seoul National University Hospital (SNUH) said Monday that they had found a solution to prevent HSCT complications by effectively producing T lymphocytes progenitor-T cells (T cells hereafter) from HSCs.

The team said if a patient with a blood tumor receives T-cells with HSCT, it can reduce the fatal infection that may occur after transplantation.

This is because T-cells prevent various viral infections by attacking and destroying cancer cells. It is differentiated in the HSCT and developed through T-precursor cells in the thymus.

HSCT is a treatment transplanting healthy HSCs after removing cancer and HSCs from blood cancer patients. It is effective and important in curing various types of blood cancer, including bone marrow failure syndromes.

However, this method has a high risk of complications and can only be applied to some patients. Also, the lack of development of T-cells causes fatal complications, such as cytomegalovirus infections, even causing death.

The research team, led by Professor Shin Dong-yeop of the Department of Hematology-Oncology at the hospital, has successfully produced T cells from HSCs.

They extracted cord blood HSCs at high purity and created an artificial thymic organoid (ATO) culture using recombinant proteins and cytokines from humans. They focused on this idea, excluding the method which uses mice-derived proteins because it did not apply to humans.

As a result, they found that T cells increased more effectively by combining a low oxygen environment's physiological conditions. The phenomenon has been confirmed in multiple amounts by the leading antioxidant agent, ascorbic acid (vitamin C).

After 200 trials, we have found a method to cultivate progenitor T cells. This will improve therapeutic performance for patients who need transplants, and contribute to enhancing the T-cell therapy, which is developing at a fast rate, researchers said.

The results were published in Stem Cells, an international stem cell journal.

Originally posted here:
SNUH finds way to produce T-cells to prevent HSCT complications - Korea Biomedical Review

NHS England is to grant immediate access to AstraZenecas cancer drug Calquence (acalabrutinib) for certain patients with chronic lymphocytic leukaemia (CLL) after NICE backed it in first draft recommendations.

NICE recommended regular NHS funding for Calquence in CLL who are considered high-risk due to 17p deletion or TP53 mutations.

It is also recommended for adults with CLL who have had at least one previous treatment and only if AbbVie and Janssens class rival Imbruvica (ibrutinib) is their only suitable treatment option.

NHS England is granting access via an interim funding arrangement with AstraZeneca, which will end 30 days after publication of positive final guidance, after which treatment will be funded by routine commissioning budgets.

However the guidance has rejected Calquence for a third group of patients with untreated, non-high risk CLL who are unsuitable for treatment with chemotherapy.

AZ said it will provide further data analyses for continued discussions with NICE about this group of patients.

Calquence was approved in CLL by the EMA last month as monotherapy or in combination with Roches Gazyvaro (obinutuzumab).

In CLL, too many blood stem cells in the bone marrow become abnormal white blood cells, and these have difficulty in fighting infections.

As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets. This could result in anaemia, infection, and bleeding.

B-cell receptor signalling through Brutons tyrosine kinase (BTK) is one of the essential growth pathways for CLL.

In B-cells, BTK signalling results in the activation of pathways necessary for growth: proliferation, trafficking, chemotaxis, and adhesion.

Calquence binds selectively to BTK, inhibiting its activity.

This is the second recommendation of a therapy for CLL in the space of a month in November it recommended AbbVie/Roches chemotherapy-free option of Venclyxto (venetoclax) and Gazyva.

NICEs decision allows for a 12-month fixed duration treatment option based on data from the phase 3 CLL14 trial.

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CLL patients in England to get AZ's Calquence after okay from NICE - - pharmaphorum

In 1932, when there was no known treatment for syphilis, the US Public Health Service (PHS) began a study into the disease at the Tuskegee Institute. The agency recruited 600 Black men into the project, primarily impoverished sharecroppers who had never visited a doctor before. Of this group, 399 had latent syphilis, while 201 others were disease-free. The participants were informed that they were being treated for bad blood, a colloquialism that was used at the time to describe numerous conditions.

The men were treated with placebos, such as aspirin and supplements, even after penicillin began to be recommended to treat syphilis in 1947, so that researchers could use them to follow the full progression of the disease. The men were not helped even as the disease progressed to late-stage infection, in which people experience a wide range of neurological symptoms including erratic behaviour, paralysis, sensory loss and eventually death. It can take up to 20 years from initial infection for these symptoms to manifest.

Details of the study were leaked to the press by a social worker and epidemiologist named Peter Buxtun in 1972. Buxtun had learned of the existence of the study in 1965 when he began working for the PHS and had unsuccessfully attempted to get it shut down twice over the following years. The story prompted public outrage and forced the study to finally be cancelled, four decades after it initially began.

By this stage, 28 of the participants had died from syphilis and 100 more had died of related complications. At least 40 of their spouses had been diagnosed with the disease and it had been passed down to 19 of the participants children.

Historical atrocities such as the Tuskegee experiment have left many people from communities of colour distrustful of the medical sector. Its a major problem, one that has become even more serious in the age of Covid-19.

People of colour have been shown to face higher mortality rates from the disease in both the US and UK. This is due to a multitude of intersecting demographic, geographical and socioeconomic factors, such as place of residence and occupational exposures. Extensive evidence also indicates that people of colour still do not receive the same levels of care as white people in community healthcare settings, which only exacerbates the matter.

Now, surveys in the US have shown that Covid-19 vaccine hesitancy is significantly higher among Black people than white people, with half of Black adults saying they wont take a Covid-19 vaccine. Likewise, a UK study has found that Black, Asian and minority ethnic (BAME) people were almost three times more likely to reject a Covid-19 vaccine for themselves and their children than the white population.

This mistrust is unsurprising given that US surveys have found medical staff to be less communicative with non-white patients than with white patients. A 2016 study even found that white medical students in the US were shockingly likely to believe Black patients experienced less pain than white patients.

Across the pond, BAME patients in the UK have reported lower satisfaction with the NHS and an overall less positive experience with doctors and nurses than white patients. Black women in the UK are five times more likely than white women to die during childbirth, and over 60% of Black people do not believe their health is as protected by the NHS as white peoples is.

Black people have generationally been hesitant to engage on initiatives like clinical trials and vaccines, says African Caribbean Leukaemia Trust (ACLT) co-founder and CEO Orin Lewis OBE. Thats historical, based on what has been done to the Black race for a long, long time throughout our history. People start to feel that if the medical establishment is going to trial something, theyll try it first on Black people, because were expendable. Whether thats true or not, it very much becomes folklore and trust becomes a problem.

People of colour are also less likely than white people to volunteer to take part in medical research. In the UK, 93% of people who signed up for the trials registry for the development of the Covid-19 vaccine were white.

People of colour have disproportionately suffered throughout the pandemic, in both the UK and US, but the legacy of institutional racism in medicine still leaves many mistrustful of the Covid-19 vaccine.

The medical establishment doesnt want to acknowledge this, they just kind of want to forget about it, says TruGenomix co-founder and chief scientific officer Dr Tshaka Cunningham. Thats not what certain communities are dealing with, particularly the African American community. That type of stuff leaves a psychological scar, but it can be overcome with rebuilding.

One way to heal these historic wounds, Cunningham says, is through the work of medical industry honest brokers. Honest brokers refer here to people of colour who are knowledgeable about medical matters, who can then share this insight with other members of their community.

Cunningham says: Lets say I were to bring a white male scientist in to talk to a group of African American church members. Theyre going to listen and be polite, but theyre not really going to trust it. When I deliver the same message, but Im just from the community, it gives a certain level of authenticity to it that helps them get over their distrust.

As a member of the Faith-based Genetic Research Institute, Cunningham goes into communities of colour predominantly African American churches to talk about genetics and genomics research and how and why people of colour can and should get involved. This year, these conversations have expanded to Covid-19 too.

Cunningham says: What I do almost daily is interface with different groups of people of colour, even in my local networks, about Covid-19 and how to stay safe. Ive done podcasts, Ive been on internet shows, Ive been on Instagram feeds with prominent hosts, talking specifically to minority communities about what we need to do to stay safe and debunking any myths that they have.

The burden here cannot fall on the honest broker alone its important work, but theres a limit to what can be expected of individual people facing up to an issue that requires institutional change. The medical industry at large, from pharmaceutical companies to public health organisations, needs to do far, far more.

Cunningham says: Once you have more Black and Brown people participating, it cant just be all on them to build the trust. Trust is a two-way street. People need to be really authentic and engaged and not view themselves as other or their patients as other.

I give some very simple solutions. Firstly, diversify the medical workforce, diversify the scientific research workforce and be very intentional about it. If you havent created opportunities or blocked certain groups from having opportunities to get training and to rise up in careers in these areas, then stop that process, because thats institutional racism.

Secondly, be authentic, engage with the community and allow the community to share in the profits that come out of their participation. Dont come to the Black and Brown community and say give us your health information and not give anything back.

I think a final piece is that just as the government has contributed to making it bad, they need to contribute to making it better. That will require some specific funding on things like cultural competency training.

The best thing to do would be some public health campaigns with scientists like myself alongside prominent sporting figures and celebrities. Lets say you took LeBron James and teamed him with me and some of my scientific colleagues that are people of colour and did a PSA about the vaccine that would send the right message to people.

The historical suffering of people of colour at the hands of the medical establishment isnt something that can be overcome overnight. The industry urgently needs to pay more credence to the concerns and fears of people of colour, in order to build the level of trust needed to ensure that vaccine uptake among ethnic minorities.

Theres no silver bullet, and things like grassroots community advocacy and engagement, diversifying the face of the industry and public health campaigns targeted at people of colour will all be necessary in ensuring the uptake of the vaccine and developing a medical industry that serves the needs of all patients.

Passive Thermal Protection and Cargo Security Solutions for the Global Supply Chain

28 Aug 2020

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Racism in the medical industry could harm the Covid-19 vaccine rollout - pharmaceutical-technology.com

Supporting stockmen in the region is a crucial part of the clubs activities and a fantastic display of young animals were brought forward to the selected venues Ballymena, Hilltown, Swatragh, Enniskillen, Keady, Camlough, Armoy, Dungannon, Markethill and Clogher. Given the restrictions we found ourselves in this year it was up to the market how they saw fit to distribute out the prize money.

Attracting good local support, the sales are always an excellent window of opportunity for commercial buyers to obtain Limousin cross cattle that are suitable for the current beef market. This year was no exception.

1st Prize 400kg 2100 (5.25p) sold by OKane Farm Ltd, Dunloy , Ballymena.

2nd Prize 350kg 1700 (4.85p) sold by Ian Lynn, Glenshesk Armoy.

3rd Prize 380kg 1820 (4.79p) - sold by Ian Lynn, Glenshesk Armoy.

1st Prize 270kg 900 (3.33p) sold by J Campbell, Ballyvaddy Road, Carnlough.

2nd Prize 210kg 700 (3.33p) sold by ST MACNISSIS College, Garron Tower.

3rd Prize 270kg 890 (3.29p) sold by J Campbell, Ballyvaddy Road, Carnlough

1st Prize 320kg 880 (2.75p) Sold by D Litter, Derrall Road, Portadown.

2nd Prize 260kg 700 (2.69p) Sold by D Litter, Derrall Road, Portadown.

1st Prize - 300kg 930 (3.10p) sold by N Hammond, Ballymaguire, Stewartstown.

2nd Prize 270kg 805 (2.98p) sold by N Hammond, Ballymaguire, Stewartstown.

1st Prize 318kg 1370 (4.30p) sold by Nigel Deens, Markethill

2nd Prize 340kg 1260 (3.71p) sold by J Rice , Armagh

1st Prize 244kg 770 (3.15p) sold by E McKeown, Crossmaglen

2nd Prize 284kg 880 (3.10p) sold by A Nugent , Keady

1st Prize 285kg 790 (2.77p) sold by Gabriel Emerson, Cushendall

2nd Prize 254kg 650 (2.56p) sold by Danny McBride, Ballycastle

1st Prize 230kg 720 (3.13p) sold by Gabriel Emerson, Cushendall

2nd Prize 210kg 650kg (3.10p) sold by Gabriel Emerson, Cushendall

1st Prize 308kg 1260 (4.09p) sold by Paul Faulkner

2nd Prize 356kg 1400 (3.93p) sold by Martin Diamond

1st Prize 282kg 930 (3.30p) sold by Paul Faulkner

2nd Prize - 452kg 1410 (3.12p) sold by Paul Faulkner

1st Prize 440kg 2250 (5.11p) sold by Darren McSorley, Omagh

2nd Prize 440kg 1900 (4.32p) Sold by Darren McSorley, Omagh

1st Prize 550kg 1250 (2.50p) sold by Ian Elliott, Enniskillen

2nd Prize 535kg 1100 (2.05p) sold by Jason Sawyers , Sixmilecross

1st Prize - 293.90 per 100 kilos sold by Alan Falloon, Armagh

2nd Prize - 282.60 per 100 kilos sold by P J McNally

1st Prize - 361.10 per 100 kilos sold by P J McNally

2nd Prize - 316.00 per 100 kilos sold by Joe Smith

1st Prize - 391.30 per 100 kilos sold by Kevin and Gerard McKee

2nd Prize - 314.80 per 100 kilos sold by Kevin and Gerard McKee

1st Prize -367.70 per 100 kilos sold by Thomas Nugent

2nd Prize 316.70 per 100 kilos sold by Kevin and Gerard McKee

1st Prize 326kg 1180 (3.62p) sold by Emmett Kelly, Augher, Co Tyrone

2nd Prize 392kg 1400 (3.57p) sold by Gordon Cutler, Florencecourt, Enniskillen

1st Prize 250kg 730 (2.92p) sold by Raymond McGovern, Derrylin

2nd Prize 270kg 740 (2.74p) sold by Raymond McGovern, Derrylin

Successful exhibitors were:

1st Prize Leo and Aaron Fearon

3rd Prize Leo and Aaron Fearon

The strength in the market for Limousin calves demonstrates how the breeds genetics continue to stand out within the sector.

The market demands fast finishing, efficient, low-cost cattle that produce carcases consistent in weight and quality.

It is a blueprint for the breed, one which it delivers extremely well and is the principle reason that buyers seek Limousin stock of all ages.

View post:
Local Limousin calves are on the money at recent suckled calf sales - Farming Life

VANCOUVER, BC / ACCESSWIRE / December 8, 2020 / FIORE GOLD LTD. (TSXV:F)(OTCQB:FIOGF) ("Fiore" or the "Company") is pleased to announce an updated resource and reserve estimate for its Pan open pit mine in White Pine County, Nevada.

Highlights:

Updated Proven and Probable mineral reserves of 24.0 million tons at a gold grade of 0.012 troy ounces per short ton ("oz/st") or 0.41 grams per tonne ("g/t") containing 290,500 ounces of gold (Table 1)

The updated mineral reserve estimate represents a 6% increase in contained gold ounces and fully replaces reserves mined since the last reserve update in September 2018

Updated Measured and Indicated mineral resources of 31.1 million tons at a gold grade of 0.014 oz/st (0.47 g/t) containing 427,400 ounces of gold (Table 2)

The updated mineral resource estimate is 99% of the resource estimate (effective February 10, 2017) at Fiore Gold's inception

An updated Life of Mine ("LOM") plan based on the updated reserve estimate extends the mine life at Pan by two years into 2025 at a mining rate of 14,000 tons per day of ore while maintaining a low life of mine strip ratio of 1.66:1

Tim Warman, Fiore's CEO commented, "Fiore's exploration team has once again added reserves and extended the mine life at the Pan Mine well into 2025. Our understanding of the geology and controls on mineralization at Pan has improved tremendously over the past three years and the team was able to successfully target new areas of mineralization particularly around the North Pit, as well as identifying potential new areas such as the Mustang target. The next program of resource and reserve expansion drilling is already underway at Pan, aimed at defining the resources that should see Pan continuing to operate for many years to come."

The updated reserve and resource estimates continue to support our strategy of replacing ounces at the Pan Mine by methodically and prudently investing internal cash flow to extend the mine life. At Fiore Gold's inception, the Pan Mine Proven and Probable mineral reserves and Measured and Indicated resources (effective February 10 and March 16, 2017 respectively) were 318,000 ounces and 430,000 ounces, respectively. Despite approximately three years of mining depletion, the updated 2020 Proven and Probable reserves and Measured and Indicated resources are 290,500 ounces (91% of original reserve) and 427,400 ounces (99% of original resource), respectively. The reserve and resource replacement has been achieved while spending approximately $1.5 million on exploration annually over the past three years. Importantly, we have achieved these results without diluting shareholders through additional equity raises or taking on corporate debt since the formation of the Company in 2017. We believe this disciplined approach distinguishes us from many of our peers.

Story continues

The goal of the recent drilling program and related reserve and resource update was primarily to convert Inferred ounces to reserve ounces. Pan Mine Proven and Probable mineral reserves now represent 77% of the Measured and Indicated resources, as compared to 61% of the last reserve update in September 2018. Future drilling programs will aim to replenish the Inferred category, particularly with newly identified targets like Mustang which to date are not included in any resource category. We believe our history of conversion and improved understanding of the geology bode well for our ability to convert Inferred resources going forward.

A Technical Report with the details of the updated resource and reserve estimate will be filed on SEDAR under the Company's profile within 45 days of the date of this news release.

Reserve and Resource Update

Table 1. Pan Mine Reserve Statement (effective June 30, 2020)

Reserve

Tons(000s)

Grade(oz/st)

Grade(g/t)

Contained Gold(Au koz)

Proven

11,426

0.014

0.47

158.3

Probable

12,031

0.011

0.38

132.2

Proven + Probable

23,457

0.012

0.42

290.5

Probable Leach Pad Inventory(recoverable)

26

Total Proven and Probable

317

Reserves stated in the table above are contained within an engineered pit design following the US$1,575/oz Au sales price Lerchs-Grossmann pit. Date of topography is June 30, 2020;

In the table above and subsequent text, the abbreviation "st" denotes US short tons;

Mineral Reserves are stated in terms of delivered tons and grade before process recovery. The exception is leach pad inventory, which is stated in terms of recoverable Au ounces;

Allowances for external dilution are applied.

Costs used include an ore mining cost of US$2.09/st, a waste mining cost of $1.97/st, an ore processing and G&A cost of US$3.13/st;

Reserves for Argillic (soft) ore are based upon a minimum 0.003 oz/st Au internal cut off grade ("CoG"), using a US$1,575/oz Au sales price and a Au Recovery of 80%;

Reserves for Silicic (hard) ore are based upon a minimum 0.004 oz/st Au Internal CoG, using a US$1,575/oz Au sales price and a Au Recovery of 60%;

Mineral Reserves stated above are contained within and are not additional to the Mineral Resource, the exception being stockpile and leach pad inventory; and,

Numbers in the table have been rounded to reflect the accuracy of the estimate and may not sum due to rounding.

Gold prices have increased significantly from the $1,250/oz level used in the previous reserve update in 2018 and we have reflected this increase in the $1,575/oz gold price used in the 2020 reserve update. Using a higher gold price naturally pulled in some areas of lower grade ore which in turn resulted in a lower average grade for the reserve estimate than in the previous 2018 reserve estimate. The grade reduction is not expected to materially impact run-rate production in fiscal 2021.

Table 2. Pan Mine Resource Statement (effective June 30, 2020)

Resource(incl. reserve)

Tons/(000s)

Grade(oz/st)

Grade(g/t)

Contained Gold(Au koz)

Measured

11,416

0.015

0.53

175

Indicated

19,714

0.013

0.44

252

Measured +Indicated

31,130

0.014

0.47

427

Inferred

3,726

0.016

0.56

61

Mineral Resources are not Mineral Reserves and do not have demonstrated economic viability. There is no certainty that any part of the Mineral Resources estimated will be converted into Mineral Reserves;

In the table above and subsequent text, the abbreviation "st" denotes US short tons;

Resources stated as contained within a constrained pit shell; pit optimization was based on an assumed gold price of US$1,700/oz, Silicic (hard) ore recoveries of 60% for Au and an Argillic (soft) ore recovery of 80% for Au, an ore mining cost of US$2.09/st, a waste mining cost of $1.97/st, an ore processing and G&A cost of US$3.13/st, and pit slopes between 45-50 degrees;

Resources are reported using an internal gold cut off grade of 0.003 oz/st Au for blocks flagged as Argillic altered or as unaltered and a cutoff of 0.004 oz/st Au for blocks flagged as Silicic altered.; and,

Numbers in the table have been rounded to reflect the accuracy of the estimate and may not sum due to rounding.

The updated Pan Mineral Resource Estimate ("MRE") estimate was carried out by APEX Geoscience Ltd. ("APEX") as part of an updated Feasibility Study led by SRK Consulting (U.S.) Inc. ("SRK"), the same firm who completed the February 2017 Pan Mine Feasibility Study.

The difference in resource grade vs reserve grade is a result of dilution incorporated in the engineered pit design that constrains the reserve estimate.

Gold mineralization at Pan occurs in near-vertical pipes and bodies of silicified solution breccia localized at the Pilot Shale-Devils Gate Limestone contact adjacent to the Branham Fault, or in stratiform-like breccia bodies and zones that run parallel or sub-parallel to the folded Pilot Shale-Devils Gate contact.

The drillhole database used to calculated the resource and reserve estimates is comprised of 1,452 exploration drillholes completed from 1978 to 2016 by previous operators (totaling 380,081 ft) and 267 holes completed from 2018 to 2020 by Fiore Gold (totaling 107,460 feet), yielding a total of 95,181 sample/interval entries.

The MRE was calculated using a block model size of 20 ft (X) by 20 ft (Y) by 20 ft (Z). APEX estimated the gold grade for each block using Ordinary Kriging with locally varying anisotropy to ensure grade continuity in various directions is reproduced in the block model. The block model was partially diluted by estimating a waste grade for the portions of the outer blocks overlapping the edge of the estimation domain boundaries using composites within a transition zone along the outer edge of the mineralized estimation domains. The waste grade was then proportionately combined with the estimated grade for the portion of the block within the mineralized domain to obtain a final grade for each overlapping block. The partially diluted block model was utilized for resource pit optimization. The MRE is reported as undiluted and only includes blocks or portions of blocks within the estimation domains.

Details regarding the methodology used to calculate the MRE and the reserve estimate will be documented in a Technical Report which will be filed on SEDAR and available on the Company's website within 45 days.

Technical Disclosure

The scientific and technical information relating to Fiore Gold's properties contained in this press release was approved by J. Ross MacLean, Fiore Gold's Chief Operating Officer and a "Qualified Person" under National Instrument 43-101, except for the information relating to the Pan Mine reserve and resource updates.

Michael B. Dufresne, M.Sc., P.Geol., P.Geo., President and Senior Principal of APEX Geoscience Ltd. and a 'Qualified Person' for the purpose of National Instrument 43-101 Standards of Disclosure for Mineral Projects of the Canadian securities administrators ("NI 43-101") has approved the disclosure of the scientific and technical information regarding the Pan Mine Resource update in this news release.

Justin Smith, P.E. Mining BSc., SME-RM, a Senior with SRK Consulting (U.S.) Inc. and a 'Qualified Person' for the purpose of National Instrument 43-101 Standards of Disclosure for Mineral Projects of the Canadian securities administrators ("NI 43-101") has approved the disclosure of the scientific and technical information regarding the Pan Mine Reserve update in this news release.

A description of the key assumptions, parameters and methods used to estimate mineral reserves and resources at the Pan Mine, as well as data verification procedures and a general discussion of the extent to which the estimates of scientific and technical information may be affected by any known legal, political or other relevant factors relating to the potential development of the mineral resources or mineral reserves, will be included in the report titled "NI 43-101 Updated Technical Report on the Pan Gold Mine, White Pine County, Nevada", with an effective date of June 30, 2020, which is being prepared by Michael Dufresne,, P.Geol., P.Geo., Justin Smith, P.E., RM-SME., Deepak Malhotra, RM-SME, Valerie Sawyer, RM-SME, Fredy Henriquez, MSc., RM-SME, and Michael Iannacchione, P.E..

Corporate Strategy

Our corporate strategy is to grow Fiore Gold into a 150,000 ounce per year gold producer. To achieve this, we intend to:

continue to grow gold production at the Pan Mine, while increasing the resource and reserve base

advance exploration and development of the nearby Gold Rock project

acquire additional production or near-production assets to complement our existing operations

On behalf of FIORE GOLD LTD.

"Tim Warman"Chief Executive Officer

Contact Us:

info@fioregold.com1 (416) 639-1426 Ext. 1www.fioregold.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Follow this link:
Fiore Gold Reports Two Year Mine Life Extension at Its Pan Mine, Nevada - Yahoo Finance

CAMBRIDGE, England--(BUSINESS WIRE)--Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T cell enhancing therapeutics, today announced that it has expanded its global, multi-target discovery and development collaboration with Takeda Pharmaceutical Company Limited (Takeda) after Crescendo achieved its sixth technical milestone.

Under its ongoing collaboration and license agreement, Crescendos proprietary transgenic platform and engineering expertise is being used to build Humabody-based therapeutics against certain targets selected by Takeda.

The collaboration expansion gives Takeda access to a range of Crescendos half-life extension Humabodies for use with its two Humabody programmes, previously licensed in November 2018 and July 2019, and Humabody programmes Takeda licenses in the future during the term of the collaboration expansion.

This is the sixth technical milestone achieved by Crescendo in its collaboration with Takeda. Crescendo has successfully delivered novel oncology-targeted Humabody lead molecules using its robust in-house discovery process.

Theodora Harold, CEO of Crescendo, commented:

Crescendo has again demonstrated its ability to deliver differentiated Humabody molecules against specific targets selected by Takeda, on schedule. The expansion of our collaboration, together with the achievement of this sixth milestone, further validates the excellent work being done at Crescendo to progress the next generation of differentiated cancer therapies.

Loc Vincent, Head, Oncology Drug Discovery Unit, Takeda, commented:

Our fruitful collaboration with Crescendo continues to show great progress. We are delighted to expand our work together, drawing on Takedas vast oncology drug discovery experience and Crescendos expertise in developing optimally constructed Humabody molecules to quickly advance novel therapeutics with transformative treatment potential towards the clinic.

-Ends-

About Crescendo BiologicsCrescendo Biologics is a clinical stage T cell enhancing company. Crescendo develops potent, truly differentiated Humabody therapeutics with a focus on innovative, targeted T cell approaches in oncology.

Leading its proprietary pipeline, Crescendo Biologics has developed CB307, a novel CD137 x PSMA bispecific for the selective activation of tumour-specific T cells exclusively within the tumour microenvironment. CB307 is designed to achieve a longer lasting anti-cancer effect whilst avoiding systemic toxicity.

The Companys ability to develop multi-functional Humabody therapeutics is based on its unique, patent protected, transgenic mouse platform generating 100% human VH domain building blocks (Humabody VH). These robust molecules can be configured to engage therapeutic targets in such a way that they deliver novel biology and superior bio-distribution. This results in larger therapeutic windows compared to conventional IgG approaches. Humabody-based formats can also be applied across a range of non-cancer indications.

Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Andera Partners, IP Group, Takeda Ventures, Quan Capital and Astellas.

For more information, please visit the website: http://www.crescendobiologics.com

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Crescendo Biologics Expands its Ongoing Collaboration with Takeda - Business Wire

Creatine is a compound produced by the body and found naturally in a variety of foods.

Creatine supplements are often used to enhance athletic performance, increase strength, and reduce muscle damage (1, 2, 3).

Creatine monohydrate, which consists of a creatine molecule paired with a water molecule, is the most common and best-researched type of creatine supplement (1).

Other types are also available. They combine creatine with other compounds intended to increase absorption or boost performance, such as magnesium, citric acid, malic acid, or hydrochloride.

However, not all creatine supplements are created equal, and with so many options available, finding a high quality supplement can be challenging.

The products included in this article were selected based on the following criteria:

Here are 10 of the best creatine supplements of 2020.

General price ranges with dollar signs ($ to $$$) are indicated below. One dollar sign means the product is rather affordable, whereas three dollar signs indicate a higher price range.

Generally, prices range from $0.10$3.13 per serving, or $8.21$56.37 per tub, package, or bottle, though this may vary depending on where you shop.

Note that serving sizes vary by product.

Pricing guide$ = under $0.50 per serving$$ = $0.50$1 per serving$$$ = over $1 per serving

Price: $

Thorne Research is a company focused on producing high quality, sustainably sourced supplements.

This unflavored product contains 5 grams of creatine per serving and is free of gluten, soy, dairy, yeast, and other major allergens.

Its also NSF Certified for Sport, meaning that it has undergone third-party testing to ensure that its free of harmful contaminants and specific substances that are banned for athletes.

Price: $

With 5 grams of creatine monohydrate per serving, this product from Klean Athlete is ideal for those seeking a simple yet high quality creatine supplement.

Like most other Klean Athlete products, Klean Creatine is NSF Certified for Sport to ensure that it meets strict quality standards.

Its also unflavored and can be easily mixed into smoothies, shakes, and juices.

Price: $

This high quality supplement is a convenient and cost-effective way to help ramp up your intake of creatine.

It contains 5 grams of creatine monohydrate per serving and is formulated without any additives or extra ingredients, such as gluten, sugar, soy, dairy, or yeast.

Plus, BulkSupplements can also provide a Certificate of Analysis (CoA) upon request, which is a detailed document that provides information on the quality, strength, and specifications of a product.

Price: $$

Available in flavors like orange, grape, and fruit punch, this creatine powder from Muscle Tech can be a delicious addition to your workout routine.

It not only includes 5 grams of creatine per scoop but also delivers 1 gram of branched-chain amino acids (BCAAs), which are a type of amino acid often used by athletes to boost performance and reduce fatigue (4).

It also contains around 36 grams of carbs per serving, which is thought to help maximize creatine retention (5).

Price: $

This product is not only free of artificial colors, flavors, and sweeteners but also made without any genetically modified organisms (GMOs) and contains just one ingredient.

Its likewise certified vegan and certified gluten-free, making it a great option for those with food allergies or dietary restrictions.

Additionally, Naked Creatine by Naked Nutrition contains 5 grams of creatine monohydrate and can be easily dissolved in your favorite pre- or post-workout beverage.

Price: $$$

With 550 calories, 54 grams of protein, and 3.2 grams of creatine per serving, this multipurpose protein powder is perfect for bulking.

It comes in a vanilla crme flavor, which adds a pleasant taste to high calorie shakes and smoothies.

Its also NSF Certified for Sport, making it a good choice for athletes seeking a safe supplement free of banned substances.

Price: $

Featuring 5 grams of creatine monohydrate per serving, this supplement is specifically designed to promote energy production and muscle growth.

In addition to being certified kosher and vegan-friendly, its certified by Informed-Choice, a third-party organization that tests sports supplements for banned substances.

Plus, its produced in a facility that has been certified for following good manufacturing practices (GMPs), which ensure that supplements are produced according to strict quality standards set by the Food and Drug Administration (FDA).

Price: $

If you prefer the convenience and ease of pills over powders, these creatine capsules from Life Extension may be a good choice.

Each serving contains approximately 1 gram of creatine, and capsules are certified non-GMO and gluten-free.

Life Extension also provides a CoA for all products to help ensure quality and promote product transparency.

Price: $$

This Power+ product from PurAthlete is made for athletes looking to increase endurance, strength, and stamina.

It features 3.3 grams of Creatine MagnaPower, a type of creatine thats combined with magnesium to enhance absorption and energy production.

Its also NSF Certified for Sport and produced in a GMP-certified facility, meaning that you can feel confident that youre getting a safe, high quality supplement.

Price: $$$

Whether youre a casual gym-goer or competitive athlete, this pre-workout supplement from Proven4 Sport can help boost your exercise routine.

Each serving contains 2 grams of creatine monohydrate, along with a blend of other ingredients like B vitamins, caffeine, and amino acids.

Whats more, this product is NSF Certified for Sport and available in a variety of flavors, including blue raspberry, cherry limeade, fruit punch, and watermelon.

When selecting a creatine supplement, be sure to check the ingredient label carefully and look for products free of artificial flavors, sweeteners, colors, and fillers whenever possible.

However, note that some supplements may contain added carbs or protein, which can help increase the retention of creatine (5).

You should also pay close attention to the dosage of creatine supplements.

Its generally recommended to start with a loading phase of 2025 grams per day for 57 days to increase muscle stores of creatine, followed by a maintenance dosage of 35 grams daily thereafter (6).

If possible, you should also choose supplements that have undergone third-party testing and are certified by organizations like NSF or Informed-Choice to ensure safety and quality.

Some companies may also provide a CoA upon request, which offers detailed information about the purity and potency of products.

Check out these two articles to help make supplement shopping a breeze:

Creatine supplements are available in a variety of forms, flavors, and dosages.

When picking the right product for you, be sure to check the ingredient label and dosage carefully.

Ideally, you should also purchase products that have undergone third-party testing or provide a CoA available upon request.

See the original post here:
The 10 Best Creatine Supplements in 2020 - Healthline

Carlo Wolters, director of Netherlands power company EPZ, has called for an extension to the operation of the Borssele NPP beyond 2033. Alternatively EPZ seeks the construction of two new large reactors at the site to enable the Netherlands to meet its energy and climate goals.

Wolters made the statement at a parliamentary debate on the role of nuclear power in the Dutch energy system, where he presented a position paper, EPZ Vision 2033 A Strategy for Dutch Nuclear Energy, which was first published on 28 November.

EPZ is currently the only Dutch party with the experience to operate a nuclear power plant in combination with a wind and solar park, the document says.

EPZ sees nuclear as a key climate-neutral source of energy, which should continue to be used in the Netherlands. For this there are two options plant life extension and/or newbuild.

As to life extension, EPZ said a letter from EPZ about this has already been sent to Minister for Economic Affairs and Climate Policy Eric Wiebes and the House of Representatives. The condition set by EPZ is that any market risk is covered in the business case, the Vision paper says. It envisages extending operation of the Borssele NPP by 10 to 20 years.

On the newbuild option, EPZ favours building two new Generation III 1500MWe units before the mid-1930s at the Borssele site. A precondition is the choice of a proven (and licensed) reactor design for which the permit and consultation processes can be completed on time, the paper notes. Subsequently, during construction, no changes to design and regulations will be made. Finally it is necessary that any market risk in the business case is covered by the government.

EPZ says construction of an existing, approved reactor concept is feasible. Generation III reactors have three times the power of Borssele and are therefore very interesting economically. They can now be purchased from various suppliers and there is sufficient space for new construction in the immediate vicinity of the existing nuclear plant, EPZ adds.

The addition of two identical nuclear power stations (with phased completion) seems the most optimal strategy, the paper notes. With an adequate project progression, the costs of a new Generation III reactor are 8-10 billion and the construction time is about eight years. With a combination of these two options, climate-neutral capacity could be in use by the mid-2030s. Borssele could even be 3500MWe, with an availability of 90%. This covers approximately 25% of current Dutch electricity demand. The paper adds: A fully climate-neutral energy system by 2050 remains within reach, even if electricity consumption continues to increase.

EPZ notes that around 2030, CO2 emissions from the electricity sector will be between 11 and 25 megatonnes. If EPZ keeps the existing nuclear power plant open and builds two new ones, the savings will be 13 megatonnes.

In September Minister of Economic Affairs and Climate Eric Wiebes said in a letter to members of parliament that more nuclear power may join solar and wind in the Dutch energy mix after 2030, in particular small modular reactors (SMRs). The International Energy Agency (IEA) said in a recent energy policy review that lifetime extension "could prove of great benefit to maintain the low-carbon generation...and the know-how of the Dutch nuclear sector".

See the article here:
EPZ calls for continued nuclear power in the Netherlands - Nuclear Engineering

New York, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Military Aircraft Modernization and Upgrade and Retrofit Market 2020-2024" - https://www.reportlinker.com/p04483599/?utm_source=GNW 61 bn during 2020-2024 progressing at a CAGR of 3% during the forecast period. Our reports on military aircraft modernization and upgrade and retrofit market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors. The report offers an up-to-date analysis regarding the current global market scenario, latest trends and drivers, and the overall market environment. The market is driven by the incorporation of CNS systems in aircraft and emergence of SVAB. In addition, incorporation of CNS systems in aircraft is anticipated to boost the growth of the market as well. The military aircraft modernization and upgrade and retrofit market analysis includes type segment and geographical landscapes

The military aircraft modernization and upgrade and retrofit market is segmented as below: By Type Combat aircraft Transport aircraft Others

By Geographical Landscapes North America APAC Europe MEA South America

This study identifies service life extension of military aircraft fleets as one of the prime reasons driving the military aircraft modernization and upgrade and retrofit market growth during the next few years.

The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters. Our military aircraft modernization and upgrade and retrofit market covers the following areas: Military aircraft modernization and upgrade and retrofit market sizing Military aircraft modernization and upgrade and retrofit market forecast Military aircraft modernization and upgrade and retrofit market industry analysis

Read the full report: https://www.reportlinker.com/p04483599/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The Global Military Aircraft Modernization and Upgrade and Retrofit Market is expected to grow by $ 2.61 bn during 2020-2024 progressing at a CAGR of...

The report gives a complete investigation of the CONTROLLED INTELLIGENT PACKAGING, PRESERVATION AND SHELF-LIFE EXTENSION industry and key market improvements. The exploration record comprises of past and figure showcase data, prerequisite, territories of use, value strategies, and friends portions of the main organizations by topographical district. The CONTROLLED INTELLIGENT PACKAGING, PRESERVATION AND SHELF-LIFE EXTENSION market report separates the market size, by volume and worth, depending upon the kind of utilization and area.

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Optimistic Scenario: COVID-19 is contained by May or June, With Normalcy Returning to Global

Operations through the End of Q2.

Conservative Scenario: COVID-19 Remains Prevalent, with Continued Impacts Lasting into Q4.

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Corporate Strategy the Manufacturers Should Be Thinking About Right Now.

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Controlled Intelligent Packaging, Preservation and Shelf-Life Extension Market to Witness Widespread Expansion During 2020 to 2026 Cargill Inc....

Growing emphasis on the food safety and longer shelf life has played an important role in the development of ingredients that aid in food preservation. These ingredients vary from simple water content to salt or sugar to chemicals like antioxidants and are used to prevent growth of microorganisms, thereby delaying the spoilage process. In terms of origin, food safety and shelf life extension ingredients can be synthetic or natural in nature.

Food preserving ingredients have been an integral part of kitchen aisles in the form of lemon, ginger, vinegar, spices, salt and sugar. Their traditional utilization was replaced by synthetic ingredients with increasing commercialization of the food industry in past decades. However, with the dissemination of knowledge related to harmful effects of synthetic ingredients, currently, the industry is witnessing a prominent shift toward natural ingredients for food safety and shelf life extension.

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Shelf Life Extension Ingredients Market Notable Developments

Shelf Life Extension Ingredients Market Dynamics

Clean-Label Trend Fuels Synthetic to Natural Transition in Food Ingredient Landscape

Naturally sourced ingredients have gained significant traction as consumer preference for natural products continues to surge. In terms of effectiveness, natural preservatives are superior in delivering greater protection and longer shelf life. As they work with equivalent efficiency and are healthful in nature, adoption of naturally sourced ingredients is increasing consistently as compared to the synthetic options.

Natural ingredients such as antimicrobials or antioxidants have additional potential health benefits also. Well aware of the increasing consumer demand for natural food products that are without artificial ingredients, manufacturers in the food ingredient market are introducing bio-based or naturally sourced food safety ingredients.

Frozen Foods Drive Demand for Specialized Food Safety Ingredients

Ranging from salads to sauces or ready meals to rice, a plethora of food products are available in frozen forms. As the demand for fresh and frozen foods increase across the globe, food manufacturers are seeking innovative ways to introduce novel food safety ingredients to extend the shelf life of frozen foods.

Manufacturers in the food safety and shelf life extension ingredient market are introducing ingredients specific to refrigerated products. Along with providing safety, these ingredients are label friendly and help in reducing sodium content while enhancing consumers sensory experience.

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Shelf Life Extension Ingredients Market Regional Outlook

North America presents lucrative opportunities for the Shelf Life Extension Ingredients Market on the back of buoyancy in regions the food and beverage industry and presence of leading F&B companies.

The market is likely to witness increasing opportunities in the developing countries of Asia pacific. These countries are witnessing huge demand for frozen foods, RTD food and beverages and processed food, thereby presenting higher potential for the market in the future.

Shelf Life Extension Ingredients Market Segmentation

The Shelf Life Extension Ingredients Market is segmented into following,

Based on type, Shelf Life Extension Ingredients Market can be segmented in,

Based in function, Shelf Life Extension Ingredients Market can be segmented in,

Based on application, Shelf Life Extension Ingredients Market can be segmented in,

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Excerpt from:
Shelf Life Extension Ingredients Market Demand, Growth, Opportunities and Analysis Of Top Key Player Forecast To 2028 - Murphy's Hockey Law