Archive for the ‘Skin Stem Cells’ Category
COVID-19: The Prevention Prescription – The New Indian Express
The health focus today is squarely on the bodys natural defense system. Until there is a vaccination, preventative measures are all we can turn to. Ayurveda can help, experts believe, especially a technique thats been gaining popularity. It's called Photo Bio Modulation (PBM). Availableat Indus Valley AyurvedicCentre (IVAC) in Mysore, itsan emerging medical practicein which exposure to low-level laser light or light-emitting diodes stimulates cellular function. This results in beneficial clinical outcomes for various conditions and diseases, primarily low immunity, in addition to lung disorders, respiratory disorders, joint problems, skin issues, and stress.
How does it work?Also known as Low-Level Laser Therapy (LLLT), it increases the production of Adenosine Triphosphate (ATP) in the mitochondria of the cells, which scavenges the free radicals. By doing so, it stimulates stem cell proliferation, lymph nodes associated with respiratory tract, the immune system and stimulates local tissues to support lung function leading to protection from asthma, bronchitis, pneumonia and Chronic Obstructive Pulmonary Disease, says Dr Talavane Krishna, Founder,President, IVAC.
Nasal ApplicationWhile PBM is gaining prominence now, processes such as nasal application, part of Panchakarma (five actions) treatment, have been a standard Ayurvedic antidote to viruses for aeons. One has to apply different herbal powders, liquid extracts, medicated ghee or oil inside the nostrils. Medications like Anu Taila, sesame or coconut oil, Brahmi ghrutha etc are antimicrobial and act as a protective filter inside the nose and throatthe primary entry point for the viruses. This simple procedure could be a daily practice for both adults and children.
Oil pulling Likewise, oil pulling with sesame or coconut oil as a daily oral health practice is useful. It involves swishing a teaspoon of oil in the mouth for three-five minutes and then spitting the oil, followed by washing/brushing the mouth. This kills bacteria that may lead to tooth decay, bad breath, and gum disease.
Rasayana This is one of the eight major branches of Ayurveda. Popularly known as a form of rejuvenation therapy, not only does it focus on anti-aging, but also immunity. This is accomplished by taking certain Ayurvedic preparations, food based on body constitution, and following an Ayurvedic way of life. This increases Ojas, the very essence of the bodys immunity. Medicines include single herbs like Ashwagandha, Shatavari, Amrita, and formulations like Chyavanaprash, Triphala, Makaradhwaja, notto mention regular body-mind detoxifications like Panchakarma and Rejuvenation.
Balance is keyKeeping the body alignedwith its natural rhythms is a prerequisite to the success of your health. For this, Ayurvedic principles namely Dhincharya (daily regime) and Rithucharya (seasonal regime) are crucial. Dhinacharya looks at aspects such as oral hygiene, yoga, pranayama, meditation, diet, bowel movements and more. Ritucharya describes the various changes in our body during the different seasonsand its effect on health. Italso teaches us how to keepa good balance.
The importance of dietcannot be negated, therefore ensure you add ginger, garlic, pepper, turmeric, clove, cumin, fenugreek and cinnamon in your food as all these ingredients build the immunesystem and bring aboutperfect balance, says Gita Ramesh, Joint MD, Kairali Ayurvedic Group.Dont forget to take warm showers and apply sesame oil on the entire body before the morning bath. Allow nostrils to be lubricated by application of cow ghee or oil, and do warm turmeric water gargles regularly, says Dr Aruna Bhide, Senior Ayurveda Doctor and Consultant, Mercure Goa Devaaya Retreat. Breathing exerciseslike Anulom vilom pranayama (alternate breathing), Kapal bhati (forceful exhalation) and Nadi shuddhi pranayama are beneficial too. Keep in mind to exercise until you sweat as this is the best way to excrete toxins.
Potions for healing(Do consult an Ayurvedic doctor)
Indukantha Kashyam Prevents the recurrence of debilitating diseases and keeps the body healthyVilwadi GulikaA tablet used as a treatment for insect bites, rodent bites, gastroenteritis etc.
Chyawanprash High in Vitamin C, it aids in the production of haemoglobinand white blood cells
Kushmandarasayana Comes in a herbal jam form and is used in respiratory conditions
TriphalaGhritam Support bowel health and aids digestion. As an antioxidant, its also thought to detoxify the body and support immunity.
AshwagandhaIt has demonstrated excellent immune-boosting effects, and has also shown to encourage anti-inflammatory and disease-fighting immune cells, thatkeep illnesses at bay
Amrita Used as a blood purifierMakaradhwaja A mineral-based preparation used for its aphrodisiac characteristics, it enhances the effectiveness of several medicines
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COVID-19: The Prevention Prescription - The New Indian Express
Cosmetic Skin Care Market is Thriving with Rising Latest Trends by 2026 | Top Players- L’Oreal, Unilever, New Avon, Estee Lauder Companies, Espa, Kao,…
Cosmetic Skin CareMarketBusiness Insights and Updates:
The latest Marketreport by a Data Bridge Market Researchwith the title[Global Cosmetic Skin CareMarket Industry Trends and Forecast to 2026].The new report on the worldwide Cosmetic Skin CareMarketis committed to fulfilling the necessities of the clients by giving them thorough insights into the Market. The various providers involved in the value chain of the product include manufacturers, suppliers, distributors, intermediaries, and customers.The reports provide Insightful information to the clients enhancing their basic leadership capacity identified.Exclusive information offered in this report is collected by analysis and trade consultants.
Global cosmetic skin care market is set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026.
Cosmetic skin care is a variety of products which are used to improve the skins appearance and alleviate skin conditions. It consists different products such as anti- aging cosmetic products, sensitive skin care products, anti- scar solution products, warts removal products, infant skin care products and other. They contain various ingredients which are beneficial for the skin such as phytochemicals, vitamins, essential oils, and other. Their main function is to make the skin healthy and repair the skin damages.Get PDF Samplecopy(including TOC, Tables, and Figures) @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-cosmetic-skin-care-market
Thestudy considers the Cosmetic Skin CareMarketvalue and volume generated from the sales of the following segments:Major Marketmanufacturerscovered in the Cosmetic Skin CareMarketare:LOral, Unilever, New Avon Company, Este Lauder Companies, Espa, Kao Corporation, Johnson & Johnson Services, Inc., Procter & Gamble, Beiersdorf, THE BODY SHOP INTERNATIONAL LIMITED, Shiseido Co.,Ltd., Coty Inc., Bo International, A One Cosmetics Products, Lancme, Clinique Laboratories, llc., Galderma Laboratories, L.P., AVON Beauty Products India Pvt Ltd, Nutriglow Cosmetics Pvt. Ltd, Shree Cosmetics Ltd
Segmentation:Global Cosmetic Skin Care Market
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Based on regions, the Cosmetic Skin CareMarketis classified into North America, Europe, Asia- Pacific, Middle East & Africa, and Latin AmericaMiddle East and Africa (GCC Countries and Egypt)North America (United States, Mexico, and Canada)South America(Brazil, Argentina etc.)Europe(Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific(Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)
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The Cell Therapy Industry to 2028: Global Market & Technology Analysis, Company Profiles of 309 Players (170 Involved in Stem Cells) -…
DUBLIN--(BUSINESS WIRE)--The "Cell Therapy - Technologies, Markets and Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.
The cell-based markets was analyzed for 2018, and projected to 2028. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.
The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 309 of these are profiled in part II of the report along with tabulation of 302 alliances. Of these companies, 170 are involved in stem cells.
Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 67 Tables and 25 Figures. The bibliography contains 1,200 selected references, which are cited in the text.
This report contains information on the following:
The report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.
Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.
Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.
Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.
Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.
Key Topics Covered
Part I: Technologies, Ethics & Regulations
Executive Summary
1. Introduction to Cell Therapy
2. Cell Therapy Technologies
3. Stem Cells
4. Clinical Applications of Cell Therapy
5. Cell Therapy for Cardiovascular Disorders
6. Cell Therapy for Cancer
7. Cell Therapy for Neurological Disorders
8. Ethical, Legal and Political Aspects of Cell therapy
9. Safety and Regulatory Aspects of Cell Therapy
Part II: Markets, Companies & Academic Institutions
10. Markets and Future Prospects for Cell Therapy
11. Companies Involved in Cell Therapy
12. Academic Institutions
13. References
For more information about this report visit https://www.researchandmarkets.com/r/7h12ne
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The Cell Therapy Industry to 2028: Global Market & Technology Analysis, Company Profiles of 309 Players (170 Involved in Stem Cells) -...
MacroGenics Reports Data, And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha
MacroGenics Reports Interim Clinical Data for Multiple Drug Candidates
MacroGenics (NASDAQ:MGNX) reported preliminary clinical data from the Phase 1 dose escalation and expansion clinical trial of MGD013 and from the Phase 1 dose expansion study of MGC018. The former drug candidate is aimed at treating patients with unresectable or metastatic neoplasms while the latter targets patients suffering from advanced solid tumors.
MGD013 aims to work by blocking PD-1 and LAG-3 checkpoint molecules to endure or reinstate the function of exhausted T cells. This dose escalation part of the study involved 53 patients suffering from advanced tumors. The patients were administered the drug candidate intravenously in cohorts of escalating flat doses of 1-1,200 mg every two weeks. For tumor-specific expansion cohorts, a flat dose of 600 mg every two weeks was selected.
As of the cutoff date of April 25, 2020, 205 eligible patients were administered the monotherapy, out of which 152 were found evaluable. Response Evaluation Criteria in Solid Tumors (RECIST) was used for measuring anti-tumor activity. For triple negative breast cancer, Objective Response Rate of 17 percent was observed while 39 percent patients showed Disease Control Rates. The ORR and DCR for epithelial ovarian cancer was 9 percent and 52 percent respectively. It was observed that the response to MGD013 monotherapy was linked with LAG-3 expression and an IFN- gene signature at baseline.
The combination cohort showed that the majority of responders whose baseline tumors were evaluated were negative for (or expressed low levels of) LAG-3 or PD-L1. This observation was in contrast to the findings in monotherapy cohort.
The other drug candidate MGC018 is being tested for solid tumors and involves delivering a DNA alkylating duocarmycin payload to dividing and non-dividing cells that express B7-H3. This ligand is found related to poor clinical outcome. The data cutoff date for the study was May 6, 2020, and by then 23 patients suffering from advanced solid tumors were enrolled in four different cohorts. The company is currently carrying out enrollment for a fifth cohort with 4 mg/kg every three weeks dose regime.
Out of the seven patients with advanced metastatic castration-resistant prostate cancer treated, five observed reductions in PSA levels of . 50%. Patients with mCRPC had been given a median of four therapies prior to MGC018, including taxane chemotherapy. The safety profile of the drug candidate has been generally manageable to date. Some of the most commonly occurring adverse events were skin and hematologic toxicities. 22 out of 24 patients reported at least one treatment related adverse event; however, no febrile neutropenia was observed.
MacroGenics is a clinical-stage biopharmaceutical company. The main focus of the company is to develop monoclonal antibody-based therapeutics for treating cancer. The company has its own proprietary suite of next-generation antibody-based technology platforms which is used for developing product candidates for different therapeutic domains.
Bristol-Myers Squibb (NYSE:BMY) reported that the FDA has sent a Refusal to File letter with regard to its Biologics License Application pertaining idecabtagene vicleucel or ide-cel. The drug candidate is being developed for treating patients suffering from heavily pre-treated relapsed and refractory multiple myeloma. The application was submitted in March 2020. Bristol-Myers Squibb is collaborating with bluebird bio (NASDAQ:BLUE) for developing this medicine.
The company stated that the FDA required the companies to provide further details related to the Chemistry, Manufacturing and Control (CMC) module of the BLA. However, it has not requested any additional clinical or non-clinical data. Bristol-Myers Squibb said that it plans to resubmit the BLA by the end of July 2020. Bristol CEO Giovanni Caforio said, We believe we submitted a completed dossier to the FDA, so what we are really discussing here is the level of detail the FDA has requested. However, the company still believes that it may accomplish expedited approval.
Bristol-Myers Squibb had acquired ide-cel as a part of its purchase of Celgene. The acquisition had brought five key pipeline assets to Bristol-Myers Squibb's portfolio. It is also one of the three key regulatory milestones required to be met for triggering Contingent Value Rights granted to the shareholders. The other two drug candidates are liso-cel and multiple sclerosis drug Zeposia (ozanimod). As per the terms of the acquisition, the approval for the drug candidate is required to be obtained by March 2021.
Ide-cel is a B-cell maturation antigen directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The drug candidate was granted Breakthrough Therapy Designation (BTD) by the FDA. It also has Accelerated Assessment status and PRIority Medicines (PRIME) designation in European Union.
Enochian Biosciences (NASDAQ:ENOB) stock jumped up as the company provided updates about three of its pipeline candidates related to HIV and HBV. Two of the presentations are related to HIV while the remaining one is concerned with HBV. The HIV trials deal with genetic modification of cells for overexpressing ALDH1, an enzyme which helps them protect against low doses of chemo agent cyclophosphamide. For HBV, mouse studies have shown the potential of using caspase-9 enzyme.
Enochian has undertaken a novel approach towards treating HIV. The in-vivo study carried out by the company showed a 164 percent increase in engraftment of genetically modified cells. The study pertains to Hematopoietic stem-cell transplantation (HSCT) mechanism which has been tested for a number of diseases including HIV. Aldehyde dehydrogenase-1, or ALDH1, is a naturally occurring enzyme in human stem/progenitor cells. It is known to provide enhanced cellular resistance to cytotoxic agents such as cyclophosphamide (CY). The company is working on the hypothesis that low dosage of cyclophosphamide may help in increasing engraftment of human stem/progenitor cells.
The data demonstrated that the percentage of peripheral blood granulocytes overexpressing ALDH1 increased from week 7 through 12 for all doses but was highest at 16mg/kg (95.2%) and 19mg/kg (93.5%). Further, the data also showed that ALDH1 expression increased in absolute number of granulocytes compared to control at all dose levels. The amount was the highest at 16mg/kg dosage. The average VCN in bone marrow cell was highest at 16mg/kg CY at the end of the study.
For its HBV treatment path, the company seeks to rely upon using the virus and cellular machinery for killing the infected cells. The study examined the expression of casp-9 in AAV2-treated HepG2 and the HBV-infected HepAD39 cell lines. AAV2 particles expressing Hijack RNA test AAV or green fluorescent protein were used for treating HBV-infected and uninfected hepatoma cell lines and primary human hepatocytes. The data showed 254% increase in casp-9 levels in the treated HBV-infected cells.
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That means that when the catalyst comes that will make or break a stock, weve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.
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MacroGenics Reports Data, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha
Want to get rid of hard skin on your feet? Try one of these foot peel masks – Yahoo Lifestyle
These top-rated foot peel masks will have your feet looking perfectly preened in no time. (Getty Images)
Yahoo Lifestyle is committed to finding you the best products at the best prices. We may receive a share from purchases made via links on this page. Pricing and availability are subject to change.
With winter finally behind us, it means our feet could probably use some extra attention.
Boot seasonoften goes together with rough calluses and cracked heels, leaving them hard and tough after too much wear.
And while working from home has many benefits for foot health, youve probably noticed that your feet are more dry than usual.
Fortunately, there are now more options than ever for you to give your feet thebaby-soft feelof a salon treatment at home, without the need for any painful scrubbing.
Unlike moisturising masks that simply hydrate and soften hard skin, peeling masks are formulated to penetrate deep into rough spots, shedding the dead skin.
The majority of masks suggest you wear the it on your feet for 60 to 90 minutes. Your skin will then naturally peel over the next seven to 10 days.
With almost 2,000 five-star ratings on Amazon, this exfoliating foot mask has a unique French formula based on milk and plant extracts.
Made up of peach, aloe vera, papaya and orange, it will effectively removed dry, dead skin and repair cracked heels after a 60-90 minute application.
Top Amazon reviews call it fantastically gross and say I can't believe how well this has worked.
The intensive foot peel that has hundreds of five-star reviews suggests you keep the socks on for one 60 minute application.
After several days hard and dry skin will start to peel awayand your feet will be sandal-ready in no time.
One top review days: Great product! Only used it once and it left my feet super-smooth for weeks. I'll definitely be using it on a regular basis.
Starskin Magic Hour Exfoliating Double-Layer Foot Mask Socks | 13 from Lookfantastic
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Infused with Lactic Acid, the double-layer foot sock is designed to give your feet gentle exfoliation and deep moisturisation.
Wear it on your feet for 60-90 minutes for 7 to 10 consecutive days and your feet should be revitalised and supple.
Enriched with exfoliating fruit extracts that gently buff away dead skin cells, the formula is designed to be poured into a pair of supplied socks and left for an hour and a half while it works its magic, leaving you with silky smooth, soft feet and heels.
I would use this again. My feet look like new, wrote one happy customer.
If you really feel like splashing out, then this luxury exfoliating foot mask is your best option.
This creamy, oil-Infused Exfoliating Foot Mask will restore rough, calloused feet in just 20 minutes.
Glycolic acid gently removes dead skin cells while coconut oil hydrates skin to reveal healthy, hydrated feet.
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Want to get rid of hard skin on your feet? Try one of these foot peel masks - Yahoo Lifestyle
QurAlis Hauls In $42M to Move New ALS Therapies Into Human Testing – Xconomy
XconomyBoston
Few drugs exist that treat amyotrophic lateral sclerosis, a progressive disease that kills the nerve cells that allow patients to initiate and control muscle movement.
QurAlis, a Cambridge, MA-based startup, has an ambitious plan to develop a number of precision therapies for the disease based on forms of the condition identified by genetic mutation or a biomarker that CEO Kasper Roet (pictured) hopes to could one day, in combination, help most ALS patients.
Now the company has raised $42 million from investors in the US, Europe, and Japanmoney that will fund a move from the LabCentral incubator in Kendall Square to its own office, more than double the companys headcount by years end, and get at least one of its programs into human testing sometime next year.
The company is leveraging stem cell research from company co-founders Kevin Eggan and Clifford Woolf, Harvard University professors whoby harvesting normal skin cells from ALS patients and turning them into cells such as the motor neurons that damages as the disease progresseshave created models with the same DNA and gene mutations as those patients in an effort to identify new therapeutics for known ALS genes.
Mutations in more than 25 human genes have been implicated in ALS, the company says, and its strategy is to systematically investigate treatments targeting specific disease-causing mechanisms in patient subgroups. Some of those genes are also believed to cause frontotemporal dementia, a common cause of dementia that QurAlis also plans to treat.
One program QurAlis is advancing is intended for patients whose neurons are damaged and killed by the overactivation of certain receptors for glutamate, a key neurotransmitter, in a process known as excitotoxicity.
The company is also working on a treatment intended to return the autophagy process, through which cells recycle unwanted or damage components, to normal functioning. To do so, QurAlis is looking to target the enzyme TBK1, which plays a key role.
Roet, in an interview, said the company views its strategy as analogous to that pursued by Bostons Vertex Pharmaceuticals (NASDAQ: VRTX), which has developed multiple drugs for forms of cystic fibrosis (CF) caused by certain mutations, and late last year received approval for a combination of those drugs for about 90 percent of all CF patients.
We have identified ALS as a disease that we think we understand now, at least for specific subgroups of patients, he said. We understand what is driving the disease and we are able to develop very specific therapies for those patients.
Eggan, Woolf, Roet, and Jonathan Fleming launched QurAlis just over two years ago with seed funding from investors including MP Healthcare Venture Management, the investment arm of Mitsubishi Tanabe Pharma; the investment arm of Amgen (NASDAQ: AMGN); and Alexandria Venture Investments. Mitsubishi Tanabe markets edaravone (Radicava), one of four FDA-approved treatments for ALS. The FDAs 2017 nod for the drug made it the only ALS therapy OKd in the past 20 years.
The Cambridge, MA-based company said the new capital, a Series A financing round, brings the total it has raised to $50.5 million. The investment was led by LS Polaris Innovation Fund, Mission BioCapital, Dutch firm Inkef Capital, and the Dementia Discovery Fund. New investors including Droia Ventures, which operates from Luxembourg and Belgium, Mitsui Global Investment, and Dolby Family Ventures also participated, as did earlier investors including Amgen, MP Healthcare, and Sanford Biosciences.
As part of the deal, LS Polariss Amy Schulman, Inkef Capitals Roel Bulthuis, Dementia Discovery Funds Jonathan Behr, and Droia Ventures Luc Dochez join Mission BioCapitals Johannes Fruehauf on the QurAlis board.
Earlier this year some of the same investors, including Amgen and Dolby Family Ventures, backed a Series A financing for EnClear Therapies, a spinout of QurAlis. That company raised $10 million to advance the development of a dialysis-like medical device designed to filter out harmful proteins in the cerebral spinal fluid of patients with neurodegenerative diseases.
Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.
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QurAlis Hauls In $42M to Move New ALS Therapies Into Human Testing - Xconomy
The Best Tea Tree Oil Balm That You Can Buy on Amazon – STYLECASTER
For anyone who has been struggling with skin issues, it can be very frustrating. Whether you have cracked cuticles that the most high-end moisturizer wont heal or eczema, it can be difficult to find a cure-all that helps fight issues across the board. The world might not have a cure for everything yet, but tea tree oil balm does work wonders on many skin issues. If youre tired of using harsh chemicals to try to fix your problems, you might want to try tea tree oil balm.
You only need a little bit of the balm, which is harder and less flexible than a cream or oil, to cover the afflicted area. Tea tree oil balm usually does not go on greasy and stays put all day long to heal and restore the skin. It works on many problems, including cracked cuticles, dry skin, severely chapped lips, calluses, athletes foot, bug bites, psoriasis, eczema, hives and itchy skin. Basically, tea tree oil balm is great to keep on your bedside or in your purse for any skin emergency. You can even use it proactively, because it can serve as a great light-weight moisturizer. It cant hurt to keep boosting your skins protective barrier.
We found the best tea tree oil balms thatll provide relief to your stressed out skin. These balms use natural ingredients to help your skin. This is the MVP of natural skincare.
Our mission at STYLECASTER is to bring style to the people, and we only feature products we think youll love as much as we do. Please note that if you purchase something by clicking on a link within this story, we may receive a small commission of the sale and the retailer may receive certain auditable data for accounting purposes.
This small but mighty 60-gram tin works on just about everything from cracked cuticles to eczema. Absorbent and not greasy, this balm heals and softens skin. Its tiny enough to fit in a small purse, so you can take it with you wherever you go. Chamuels balm is made of tea tree oil, green tea, peppermint oil, lemon oil, olive oil and beeswax. It doesnt contain any harsh chemicals, parabens or artificial ingredients. The balm has a slight fresh, citrus smell, but it isnt overpowering.
Image: Amazon
This Wonder Balm is primarily made of oils, including tea tree, eucalyptus, macadamia, olive oil and beeswax. Its designed to restore your skins protective barrier and provide relief of your skin. It also heals dry skin, especially on your feet, hands and elbows. When you sweat, your creams often sweat away but that isnt the case for this balm. The lightweight, non-greasy formula stays put even when youre moving. This cream doesnt contain any preservative, parabens or petroleum.
Image: Amazon
This balm includes tea tree oil, fruit stem cells, almond oil, eucalyptus oil and lavender oil. The balm works hard to restore balance and repair your skin. It can help with annoyances such as razor burn, dry ashy skin, psoriasis, severely chapped lips and bug bites. You do need to use a little bit of elbow grease to get this hard, firm balm out of the container, but it does work well after that.
Image: Amazon
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The Best Tea Tree Oil Balm That You Can Buy on Amazon - STYLECASTER
Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003 – GlobeNewswire
Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003
Mont-Saint Guibert, Belgium, 13 May, 2020: Novadip Biosciences (Novadip or the Company), a clinical-stage biopharmaceutical company leveraging its proprietary tissue regeneration technology platform, today announces positive data from the interim analysis of its Phase I/IIa clinical trial for autologous NVD-003 in adults with non-healing fracture of the lower limb.
NVD-003 is a novel autologous cell-based osteogenic (bone healing/[bone forming]) product that has been generated from Novadips proprietary 3M tissue regeneration platform. This platform is aimed at healing damaged tissues by restoring their natural physiology and consists of a 3-dimensional, scaffold-free extracellular matrix (ECM), utilizing differentiated adipose-derived stem cells (ASCs) to restore the physiology of natural healing. NVD003 presents as a scaffold-free 3D implant to fill critical-size bone defects where healing is compromised.
This phase I/II study is investigating in five European centers the potential of NVD-003 to promote bone union in nine adults with a non-healing fracture of the lower limb. There was 100% manufacturing success for NVD-003 and grafting surgery was completed successfully in all patients without deviating from standard medical practice. To date, with a median of 12 months post-treatment, no NVD003 related safety signal has been reported. Further exploratory analysis performed on data from the first five patients to complete a six month follow up showed a strong positive trend in radiological healing with confirmed bone formation for all patients and radiologically confirmed union for three of the patients.
Prof. Gunnar Anderson (MD, PhD), Professor and Chairman Emeritus of the Department of Orthopedic Surgery at Rush University Medical Center, Chicago, Illinois and Chairman of the Scientific Advisory Board commented: The early results of this study are remarkable both clinically and for the patients and we look forward to replicating these in a larger group in the future. It is hugely encouraging that we may potentially have a future solution for these patients with unmet needs.
Dr. Denis Dufrane (MD, PhD), Chief Executive Officer, Chief Scientific Officer commented: We are encouraged by the data from this interim analysis, which demonstrates the potential of our tissue regeneration 3M3 platform to restore natural healing processes in patients with reputedly difficult to treat bone defects. We look forward to further progressing NVD-003s clinical program in bone non-union and in patients with other similar conditions with no effective treatment option and hope to provide full study results in 2025.
NVD-003 is also in clinical stage for congenital pseudarthrosis of the tibia (CPT), a rare and disabling pediatric condition with very limited treatment options and has demonstrated clinical proof-of-concept in case studies.
Novadips tissue regeneration platform drives several new classes of product candidates with an initial focus on autologous cell therapies for critical size tissue reconstruction. Allogeneic therapeutics are in development for prevalent and complex tissue defects for bone and skin tissue and exosomes/miRNA-based therapeutics are being developed for immediate (off-the-shelf) clinical use.
- End -
Notes to editors
Novadip Biosciences
Novadip Biosciences is a clinical stage biopharmaceutical company leveraging its unique 3D tissue regeneration technology platform to generate multiple product candidates to address hard and soft tissue reconstruction for patients who have limited or no treatment options. The companys proprietary 3M3 platform is a 3-dimensional, extracellular matrix that utilizes adipose-derived stem cells to deliver highly-specific growth factors and miRNAs to mimic the physiology of natural healing and creates a range of products that address specific challenges in tissue regeneration. Novadips initial focus is on critical size bone reconstruction. The company is also applying its 3M3 platform to develop truly novel off-the-shelf/allogeneic therapies to address more prevalent tissue defects and miRNA/exosome products for broader indications. For more information, visit http://www.novadip.com .
For further information, please contact:
Novadip Biosciences
Denis Dufrane
Chief Executive Officer, Chief Scientific Officer
+32 (10) 779 220
For media enquiries:
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Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003 - GlobeNewswire
Protocol Management, Off-the-Shelf Therapies Help Bring CAR T Into More Settings – Targeted Oncology
Carlos R. Bachier, MD
Chimeric antigen receptor (CAR) T-cell therapies quickly burst into the spotlight of hematology-oncology disease management because of their potential to illicit deep and durable responses from patients whose disease is relapsed or refractory to multiple previous lines of therapy. Relevant professional meetings and oncology publications exploded with research and news about CAR T cells, and this cellular therapy strategy is now being explored across hematologic and solid malignancies.
CAR T cells are a scientific revolution, Tania Jain, MBBS, assistant professor of oncology at Johns Hopkins University in Baltimore, Maryland, said in an interview with Targeted Therapies in Oncology (TTO). They have brought about a paradigm shift in terms of how were treating patients.
The 2 currently FDA-approved CAR T-cell therapies, axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), are both indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma; additionally, tisagenlecleucel is approved for patients up to 25 years with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1-3 With a second wave of approvals likely on the horizon for therapies such as lisocabtagene maraleucel (liso-cel) and idecabtagene vicleucel (bb2121), CAR T is gaining traction and will likely play an increasingly prominent role in the future treatment paradigm in oncology.
CAR T-cell therapy administration is largely limited to the inpatient setting at both academic institutions and large accredited cancer centers, making such treatments unavailable to most patients. Other challenges with this type of therapy include its potential to cause serious toxicities resulting in organ damage and death.4
David G. Maloney, MD, PhD
Due to the promising efficacy of these agents, investigators have been working toward viable solutions to bring CAR T-cell therapies to more patients by alleviating difficulties associated with therapy delivery and patient care.
CAR T-cell therapies, both those currently approved and the many being explored in late-phase clinical trials, are produced from autologous T cells obtained from the patient receiving therapy. This personalization has led to tremendous success, yet it is a large part of why CAR T-cell therapy use remains limited to a select group of patients.
Time is an important consideration for patients who have experienced multiple relapses and may be too weakened by numerous lines of prior therapy to wait several weeks for the CAR T-cell manufacturing process. The effects of previous treatments or the disease itself can also present challenges, as manypatients are rendered lymphopenic and may be unable to produce enough T cells for harvesting. Roadblocks may remain for patients who are not limited by these factors; manufacturing success and effectiveness of the CAR T-cell product can be negatively influenced by disease-related dysfunctions of patients T cells.4
A new option, off-the-shelf CAR T-cell products, may help solve these problems. These premade products are manufactured using allogeneic donor cells (instead of autologous cells from the patient), and they present immediate advantages to clinicians, such as immediate availability, opportunity for product standardization, and decreased cost.5
The advantages [include] being able to access the cellular therapy in real time, as opposed to autologous products that havetobe manufactured,Craig S. Sauter, MD, clinical director of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center in New York, New York, explained in an interview withTTO. This is particularly important for patients who are not responding to therapy, which is a current requirement for treatment with CAR T cells, he added.
Findings from a phase I trial (NCT01430390) in patients with relapsed or refractory B-cell malignancies showed that patients with non-Hodgkin lymphoma (NHL) experienced durable responses with an Epstein-Barr virusspecific cytotoxic lymphocyte CAR product derived from cells harvested from third-party donors (rather than from their more precisely matched stem cell donors). All 4 patients with NHL and a single patient with chronic lymphocytic leukemia, who were treated with third-party cells, remained disease free and alive at the time of analysis, with a median follow-up of over 2 years.6
The advantages [of this type of therapy are] that it eliminates the need for apheresis [and] shipping cellular products back and forth. [Instead, clinicians] have a pharmaceutical product on the shelf for access, Sauter, who was an author on the trial, said. Another notable product being investigated in clinical trials is UCART19, an allogeneic engineered anti CD19CAR T-cell product, which is being evaluated in the phase I CALM trial in adult patients with relapsed or refractory B-cell ALL (NCT02746952) and in the phase I PALL trial of pediatric patients with relapsed or refractory CD19-positive B-cell ALL (NCT02808442). Other off-the-shelf agents are described in theTABLE.5
Issues with inpatient CAR T-cell therapy administrationinclude high demands on health care resources and strain on patients and their families. Moving treatment to the outpatient setting has the potential to reduce this strain; however,clinicians taking over care of patients receiving CAR T-cell therapy must be prepared with the proper resources to identify and manage adverse events associated with therapy.
One of the most notable risks to patients receiving CAR T-cell therapy is cytokine release syndrome (CRS), a systemic inflammatory response that is characterized by increased serum levels of inflammatory cytokines, fever, hypotension, hypoxia, and organ dysfunction.4 [CAR T] can also lead to neurological events and can cause confusion and, in some patients, seizures,Carlos R. Bachier, MD, Director of Cellular Research at Sarah Cannon Cancer Center in Nashville, Tennessee, explained in an interview with TTO.
Regardless of the infusion setting, patients require close monitoring in the hours and days following therapy administration. A review byLucrecia Yez, PhD, MS, and colleagues stated that key criteria for treating patients in the outpatient setting include an educated caregiver and necessary infrastructure allowing for outpatient visits plus adequate emergency and intensive care unit (ICU) access. Patients followed as outpatients must be given twice-daily temperature checks for a minimum of 14 days following treatment and preferably extending up to 3 to 4 weeks following infusion. Anysigns of back pain, skin rash, dizziness, chills, shortness of breath, chest pain, tachycardia, or neurological events that may indicate neurotoxicity or signs of CRS must be reported immediately so treatment can begin as quickly as possible.7
Because of the risk of CRS and neurotoxicity, both FDA-approved agents are restricted under the Risk Evaluation and Mitigation Strategy, an FDA-mandated program that builds in caution for use of agents with serious safety concerns.8,9 Therefore, 2 doses of tocilizumab (Actemra), an interleukin (IL)-6 receptor antagonistthat was approved in 2017 for management of CRS associated with CAR T-cell therapy,1,4 should be on hand for each patient before the infusion of CAR T cells. Steroids have also demonstrated efficacy against CRS, but concernssurrounding CAR T-cell suppression with these agents have established them as a second-line choice after tociluzumab.9
Immune effector cellassociated neurotoxicity syndrome (ICANS) is a group of neurologic symptoms associated with treatments such as CAR T-cell therapy. Predisposing factors include younger age, higher tumor burden, high levels of pretreatment inflammation, and history of early or high-grade CRS. Treatments for complications of ICANS vary. Some centers may prescribe prophylactic antiepileptic medications, such as levetiracetam, to prevent seizures in patients with grade 2 or higher neurologic events. AntiIL-6 therapy can be considered in patients with concurrent CRS, but corticosteroids are the preferred regimen in those with neurotoxicity alone.9
In February of this year, the investigational CAR T-cell product liso-cel was granted priority review by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma who had undergone at least 2 prior therapies.10 Investigators believe that liso-cel therapy may have a place in a broad range of patients and in the outpatient setting.11
It turns out liso-cel has a low incidence of [CRS and ICANS], and they occurred relatively late compared with other products, said Bachier. Because of this low incidence, the strategy was to deliver liso-cel in an outpatient setting.
The feasibility of liso-cel administration on an outpatient basiswas evaluatedby Bachier and colleagues, and the results were presented at the 2020 Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood & Marrow Transplant Research, held February 19 to 23, 2020, in Orlando, Florida.12
The authors analyzed data from 3 clinical trials of liso-cel, with a focus on the subset of participants who were treated as outpatients. The included trials were the phase I TRANSCEND-NHL-001 (NCT02631044) and phase II OUTREACH (NCT03744676) trials in patientswhohadundergone at least 2 lines of prior treatment, as well as the PILOT study (NCT03483103), which examined liso-cel as second-line therapy in patients who were ineligible for autologous hematopoietic stem cell transplant because of age, organ function, or ECOG performance score. All 3 studies allowed outpatienttreatment, with some patients receiving their therapy in the nonuniversity setting.
This clinical trial included sites that were not a part of a university but had experience treating patients for stem cell transplant, Bachier said. Some of these sites that participated were notyour traditional university centers that had traditionally been involved in the development of these therapies.
Much caution was required in order to maximize patient safety and treatment efficacy. The approach of doing CAR T-cell therapy, in general, in the outpatient setting requires a robust clinical ability of the centers, said coauthor David G. Maloney, MD, PhD, medical director of Cellular Immunotherapy at the Immunotherapy Integrated Research Center of Fred Hutchinson Cancer Research Center in Seattle, Washington, in an interview. We were able to get people safely to the hospital, and it was rare that you would have to do escalation of care when people were admitted. Most of the time, patients could bemanagedand wereout of the ICU, withrare exceptions. But again, you still have to have the wherewithal to get patients to the ICU pot entially for aggressive care if needed.
Results of the analysis of outpatient data from the 3 trials showed that rates of toxicity and response were similar to those previously reported for the entire patient cohort (both inpatients and outpatients) of the TRANSCEND-NHL-001 trial.
Based on these results, the indication is that you can deliver [liso-cel] in the outpatient setting and the outcomes are good compared with those treated in the inpatient setting, said Bachier. Aside from that, it also showed that liso-cel could be safely administered outside of university programs and in more community-based programs, most of them being aligned [with] or part of stem cell and bone marrow transplant programs.
When planning or setting up a CAR T-cell therapy outpatient program, investigators anticipate possible barriers to successfultreatment. The greatest barrier, according to Bachier, is access to physicians and staff who are knowledgeable and trained to manage toxicities related to CART-cell therapy. These therapies still should not, in my opinion, be delivered [by clinicians in] community centers that do not have the expertise to deliver the therapies safely, he said.
Maloney added that centers should be required to have the ability to triage patients 24/7 and allow for patients to be directly admitted to the hospital if needed. In the case of the analysis of outpatient data from the 3 liso-cel trials however, he said, We found that around 30% to 40% of patients did not actually ever require hospitalization, whichis quite interesting. Most of the 60% to 70% of patients who were hospitalized were admitted for fever, he added.
In addition, sites must gain accreditation and approval, Jain pointed out.
Every center that intends to do CAR T-cell therapy is first approved by each of the companies [that manufacturethese agents], Jain said. The centers also have to be approved by FACT [Foundation for the Accreditation of Cellular Therapy], which is the same organization that approves centers for allogeneic stem cell transplant. These are some of the largest things that a center needs to go through, which takes care of things like developing standard practices and other guidelines to make sure that these [therapies] are used safely and appropriately.
As investigators and oncologists explore the feasibility of moving CAR T-cell therapy into more settings, 2 questions arise: What settings have on this therapy?
What type of training and skills do clinicians need? Like other clinicians, Sauter has concerns about new allogeneic cellular therapies,andhe hopes future research will focus on mitigating these challenges. The concern would be that these are not autologous products and there is the risk of rejection from the host immune system, he said. Strategies to circumnavigate that risk are at the forefront of investigationin off-the-shelf CAR T cells.
The research is not stopping with CAR T-cell therapy,though. Were seeing a lot of new molecules coming in that will be challenging the roles of CAR T cells, [such as] specific antibodies, which may even work in cases of CAR T-cell failure, Maloney said. We are still learning how to make those more effective and safer.
References:
1. FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine releasesyndrome.FDAwebsite.PublishedAugust30,2017.AccessedApril14, 2020. bit.ly/2RC4eQ8
2. FDA approves axicabtagene ciloleucel for large B-cell lymphoma. FDA website. Published October 18, 2017. Accessed April 14, 2020. bit.ly/2yYIQOp
3. FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma. FDA website. Published May 1, 2018. Accessed April 14, 2020. bit.ly/34zPoi8
4. Rafiq S, Hackett CS, Brentjens RJ. Engineering strategies to overcome the current roadblocks in CAR T cell therapy. Nat Rev Clin Oncol. 2020;17(3):147167. doi: 10.1038/s41571-019-0297-y
5. DepilS,DuchateauP,GruppSA,MuftiG,PoirotL.Off-the-shelfallogeneic CAR T cells: development and challenges. Nat Rev Drug Discov. 2020;19(3):185199. doi: 10.1038/s41573-019-0051-2
6. Curran KJ, Sauter CS, Kernan CS, et al. Durable remission following off-theshelf chimeric antigen receptor (CAR) T-cells in patients with relapse/refractory (R/R) B-cell malignancies. Presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, 2020; Orlando, FL. Abstract 120. bit.ly/2ufDYCu
7. Yez L, Snchez-Escamilla M, Perales MA. CAR T cell toxicity: current managementandfuturedirections. Hemasphere.2019;3(2):e186.doi:10.1097/ HS9.0000000000000186
8. Risk evaluation and mitigation strategies | REMS. FDA website. Updated August 8, 2019. Accessed April 14, 2020. bit.ly/2ykhLVt
9. JainT,BarM,KansagraAJ,etal.UseofchimericantigenreceptorTcell therapy in clinical practice for relapsed/refractory aggressive B cell non-Hodgkin lymphoma: an expert panel opinion from the American Society for Transplantation and Cellular Therapy. Biol Blood Marrow Transplant. 2019;25(12):2305-2321. doi: 10.1016/j.bbmt.2019.08.015
10. U.S. Food and Drug Administration (FDA) accepts for Priority Review Bristol-Myers Squibbs Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B-cell lymphoma. News release. Bristol-Myers Squibb; February 12, 2020. Accessed April 15, 2020. bit.ly/37ruQbs
11. Helwick C. Strong activity shown for lisocabtagene maraleucel CAR T-cell therapy in aggressive large B-cell lymphoma. ASCO Post website. Published February 25, 2020. Accessed April 15, 2020. bit.ly/3eoD0pT
12. Bachier CR, Palomba ML, Abramson JA, et al. Outpatient treatment with lisocabtagene maraleucel (liso-cel) in 3 ongoing clinical studies in relapsed/refractory (R/R) large B cell non-Hodgkin lymphoma (NHL), including second-line transplant noneligible (TNE) patients: TRANSCEND NHL 001, OUTREACH, and PILOT. Presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, Orlando, FL. Abstract 29. bit.ly/37I7DC9
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Protocol Management, Off-the-Shelf Therapies Help Bring CAR T Into More Settings - Targeted Oncology
Growing Number of Patients Suffering From Neurological Disorder to Support the Growth of Global Autologous Cell Therapy Market, TMR – P&T Community
- The global autologous cell therapy market is expected to witness a massive 18.1% CAGR during the tenure of 2019 to 2029
- During the tenure of 2019 to 2027, the global autologous cell therapy market shall rise from 7.5 Bn in 2018 to US$ 34.7 Bn by the end of 2027
ALBANY, New York, May 11, 2020 /PRNewswire/ -- As a result of growing pandemic of COVID-19, the pharmaceutical industry is investing a major amount in research and development of an effective vaccine that can help the doctors to save lives and help controlling the pandemic. As per a recent analysis by Transparency Market Research over pharmaceutical sector, it was found that the global autologous cell therapy market is witnessing a major push. The market is projected to grow exponentially during the tenure of 2019 to 2027 and is expected to witness a substantial 18.1% CAGR during this tenure. Moreover, the global autologous cell therapy market is expected to register a value of US$ 34.7 Bn by the end of 2027, says a recent report by Transparency Market Research.
"COVID-19 has impacted the economy at global level. With the death tolls still on the rise in developed and developing countries, the pandemic nowhere seems to get stop. However, the pharmaceutical sector is constantly investing in research and development. Nevertheless, the industry is majorly investing in autologous cell therapyto find an effective cure for CORONA Virus. Owing to these research and development, the global autologous cell therapy market is projected to grow exponentially during the tenure of 2019 to 2027" Transparency Market Research.
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Major Finding in Global Autologous Cell Therapy Market Study
Explore the latest study on global autologous cell therapy market under the title: Autologous Cell Therapy Market (Source - Bone Marrow and Epidermis; Application - Neurology, Orthopedics, Cancer, Wound Healing, CVD, and Autoimmune; End User - Hospitals, Ambulatory Centers, and Research Centers) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2019 2027 at https://www.transparencymarketresearch.com/report-toc/715
Major Drivers Propelling the Growth of Global Autologous Cell Therapy Market
Growing cases of Neurological Disorders to Propel the Growth
The world is witnessing a massive growth in the number of patients suffering from neurological diseases. The report by Transparency Market Research states that there are more than 50 Mn people suffering from autoimmune disorder which can cause a painful death. In order to develop an effective drug that can help the neurological patients, the pharmaceutical industry is investing massive in autologous cell therapywhich as a result is propelling the growth of global autologous cell therapy market during the tenure of 2019 to 2027.
Strong Government Support to Boost the Growth of the Autologous Cell Therapy Market
Governments across the globe are encouraging pharmaceutical industry to develop an effective cure for Parkinson's, nervous breakdowns, and most importantly COVID-19. This has significantly helped the players to develop new drugs. Owing to this support, the global autologous cell therapy market shall witness a substantial growth during the tenure of 2019 to 2027, states the report by Transparency Market Research.
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Major Challenges Mentioned in the Global Autologous Cell Therapy Market
The major challenge that might impede the growth of global autologous cell therapy market is the cost of the therapy. Since the cost of therapy is quite high, the some of the patient might not be able to afford it which might deplete the growth of global autologous cell therapy market during the tenure of 2019 to 2029. However, with ongoing research and development in the pharmaceutical industry, there are high chances that the world might see a cost effective therapy in the global autologous cell therapy market in future.
Global Autologous Cell Therapy: Regional Analysis
North America shall account for the largest share in the global autologous cell therapy market in future. It is noticeable that the regional front of the global autologous cell therapy market was dominated by this particular region in 2018. This dominance is the result of improving healthcare infrastructure, technological development and supportive government efforts. Owing to these factors the global autologous cell therapy market is expected to be dominated by North America during the tenure of 2019 to 2027.
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Competitive Analysis
The global autologous cell therapy market is highly progressive yet highly consolidated. The nature of the market is the result of presence of AA handful of prominent players. However, due to this the new players are unable to enter the global autologous cell therapy market. To overcome this situation, the new players are merging and collaborating with the established players of global disposable face mask market.
The global autologous cell therapy market is segmented in the basis of:
Global Autologous Cell Therapy Market, by Source
Global Autologous Cell Therapy Market, by Application
Global Autologous Cell Therapy Market, by End-user
Global Autologous Cell Therapy Market, Region
Explore Transparency Market Research's award-winning coverage of the global Healthcare industry:
Autoimmune Disease Diagnostics Market- the global autoimmune diseases diagnostics market is expected to exhibit a CAGR of 3.8%. The global autoimmune disease diagnostics market is likely to reach US$17.06 bn by 2023. The stiff price competition among players is expected to impact the growth of the market in a negative way.
Stem Cells Market- The global market for stem cells is projected to reach a value of US$270.5 bn by the end of 2025. The market is likely to exhibit a strong 13.80% CAGR between 2017 and 2025
Cell Therapy Market-The study reports an insight about the global cell therapy market, along with its current and the past market situation. This enables the customers to comprehend the situation before entering or investing in the market. The report gives driving components fueling the development of the market, restrictions which are probably going to limit the market development, and so forth.
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New Study Suggests the Consequences of Oxidative Stress on Telomeres – Truth In Aging
A decade ago, scientists won the nobel prize for connecting the dots between telomeres and aging. Telomeres are the protective caps on the ends of the strands of DNA called chromosomes. Telomeres shorten every time a cell divides. When they become very short, they trigger cell crisis and cell death.
Since this discovery was made, researchers have found new insights into telomeres and their connection to wrinkled skin, as well as how their length might be extended.
Scientists have uncovered new information on telomeres that could help combat the effects of inflammation and aging. Researchers from the University of Pittsburg recently discovered how oxidative stress plays a critical in the link between telomeres and cancer. I dont want to blind you with science (telomeres are a complex area), but every breakthrough into telomeres will ultimately equal a breakthrough in understanding how we age and how we can keep cells including our skin cells healthy.
Telomeres are composed of repeated sequences of DNA. The results from this study suggest that the mechanism by which oxidative stress accelerates telomere shortening is by damaging the DNA precursor molecules, not the telomere itself. This will have a big impact on appreciating how to manage oxidative stress to prevent aging and diseases such as cancer.
At Stanford University School of Medicine, scientists claim they can now lengthen teleomeres. Skin cells with telomeres lengthened by the procedure were able to divide up to 40 more times than untreated cells (source).
However, longer teleomeres is not necessarily associated with a longer life (source). Indeed, those naysayers say that good diet and an exercise regimen will do that. Yet, it does seem that preventing further shortening of the telomeres could be beneficial, especially for aging skin. Telomeres are likened to the tips of shoelaces that stop them unraveling and so you really want to be thinking about how to stabilize your telomeres. Happily, advances in skin care can help you out. There are three approaches to consider: special ingredients that target telomeres, ingredients that prevent oxidative damage (known, of course, as antioxidants) and stem cells.
Target your telomeres
One very interesting ingredient is called astragalus, and although it is rare, we do have a couple of Truth In Aging finds with it. But first, what is it and how does it work? In 2008, a UCLA AIDS Institute study found that a chemical they called TAT2 from the astragalus root, which is frequently used in Chinese herbal therapy, can prevent or slow the progressive shortening of telomeres. It can be found in Prana Reishi Mushroom Shield ($42 in the shop) and ExPrtise Effective Anti-Aging Face Serum ($120 in the shop).
Another ingredient to look for is treprenone, also marketed under the name of Renovage. Its promise is to stabilize telomeres, so at the very least they won't shorten. Maintaining telomere length extends the Hayflick Limit (the rate at which cells turn over before conking out completely) by one third. Youll find treprenone (Renovage) in Your Best Face Correct ($150 in the shop) Your Best Face Boost ($65 in the shop.
Amp up with antioxidants
The research is clear: Preventing oxidative damage is the job of an antioxidant. Free radicals are charged chemical particles of oxygen that enter into destructive chemical bonds with organic substances such as proteins, as explained by Gerald Imber, MD. Antioxidants limit the production of free radicals and therefore help prevent oxidative stress. There are many sources in plants, and vitamins are also antioxidants.
There are 33 antioxidants in Skin 2 Skin Aging Intervention Cream ($73 in the shop), including the universal antioxidant alpha lipoic acid. The powerful antioxidants in Your Best Face Rescue ($145 in the shop) include spin trap, an advanced form of vitamin C and EGCG. Bee venom has some 18 active compounds include antioxidants, peptides with powerful anti-inflammatory actions, and enzymes. It is the key ingredient in LaCrme Beaut Luxurious Bee Venom Rich Face Treatment Cream ($202 in the shop).
Look for plant stem cells
Plant stem cells never age. British scientists found that plant stem cells were much more sensitive to DNA damage than other cells. Once they sense damage, they trigger death of these cells before it spreads and causes more. In addition, they have the ability to stimulate cell renewal and replace specific cells in need of repair.
Ao Skincare Raw Nourish AM Treatment ($65 in the shop) has the powerful antioxidant astaxanthin and plant stem cells.
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New Study Suggests the Consequences of Oxidative Stress on Telomeres - Truth In Aging
Those with compromised immune systems are the most vulnerable to COVID-19. They are also the most prepared. – Richmond.com
Henry Budzynski, a 65-year-old airplane mechanic, is one of a small segment of society that is the most vulnerable to the coronavirus: those whose immune systems are compromised. He is undergoing cancer treatment and says, I cant afford the virus right now."
He stays home as much as he can, but every Wednesday, Henry Budzynski drives to a doctors office in Mechanicsville, where an inch-long needle is stuck into his skin just above his belly button, and a shot of chemotherapy is injected into the fatty tissue around his stomach.
Because of the cancer called amyloidosis that inhabits his body, his immune system is 40% to 50% the strength of a healthy persons. Later this month, after he checks himself into the 10th floor of the Massey Cancer Center for a high dose of chemotherapy and a stem cell transplant, his immune system temporarily will cease to exist altogether.
The timing undergoing such a procedure during a pandemic isnt ideal, but he has no other choice.
Budzynski, a 65-year-old airplane mechanic, is one of a small segment of society that is the most vulnerable to the coronavirus: those whose immune systems are compromised. Should he contract COVID-19, his body would be less prepared to fight off the virus, and he would be less likely to survive. Chemotherapy, certain types of cancer and organ transplants can cause ones immune system to be weakened.
I cant afford the virus right now, Budzynski said.
But the immunocompromised are also, in many ways, the most prepared to combat the pandemic. They were comfortable with social distancing before there was a name for it. Theyre adept at keeping their hands clean and watching what they touch.
Its been months since Budzynski stepped foot into a Lowes, Home Depot or Food Lion. When its time to buy groceries, he drives to the store with his wife, Rosemary, and waits in the car while she shops. Riding in his vehicle, which he designated a clean space, is off limits to everyone but Rosemary and their daughter.
Wednesday is a milestone in Budsynzkis treatment. After a year of weekly chemo shots to different points on his abdomen, this will be the final injection. His upcoming treatment, he said, should extend his life another 20 years.
While Budzynski cant afford to wait out the pandemic, other cancer patients have decided that COVID-19 poses a greater threat than their cancer. Surgery often means entering the same building where the virus is treated and interacting with potential vectors.
Even if COVID patients are corded off, the virus can still spread. One study by the U.S. Centers for Disease Control and Prevention found that the coronavirus could be found on half of the shoes of medical staffers. The virus was even discovered on hospital floors not walked by COVID patients.
Thats all my patients need to hear, said Dr. Kelly Hagan, a hematologist-oncologist with the Virginia Cancer Institute.
One of Hagans patients, an 88-year-old woman, was recently diagnosed with breast cancer. In a normal world, her surgery would have been scheduled immediately. Instead, she asked to delay it until July or August, and Hagan accepted. Six months ago, the doctor said, such hesitancy never would have been tolerated.
Hagan has found herself asking questions shes never asked in her career: Are some patients better off without immediate treatment? She examines the cancer, and how aggressively it spreads. She asks herself if the patient can survive two months without intervention. She studies the comorbidities, or risk factors, of the patient.
These questions, she said, involve the art of medicine more than its science.
Dr. Eric Douglas, with his dog, Jayden, could not visit hospitals even before the pandemic. He has a disease that causes cancerous cells to replace his disease-fighting white blood cells. A cold can spiral into pneumonia
Dr. Eric Douglas couldnt visit hospitals even before the pandemic. The cancer inside him, Waldenstroms macroglobulinemia, causes cancerous cells to replace the disease-fighting white blood cells that make up his bone marrow. A simple cold can spiral into pneumonia.
Disease can overtake his body without any explanation for its origin. In 2015, he nearly died of septic shock, and he doesnt know why.
His cancer forced him to leave his career in anesthesiology, but Douglas, 64, accepted the transition as an opportunity to remake himself. He went back to school and earned masters degrees in theology and religion. He now teaches part time at Randolph-Macon College and is on staff at New Hanover Presbyterian Church.
When the pandemic reached Virginia, he pulled down the stairs to his attic and retrieved two boxes of surgical masks he had stored in his home. He had purchased them during the 2009 swine flu epidemic, and he strapped one over his ears recently when he drove to UPS to mail a package a sweater knitted by his wife for his 1-week-old grandson he had not yet met. He sat in his Toyota RAV4 and waited until every customer left the building.
When he returned to his car, he wiped down his hands with sanitizer and drove home. But his children were upset when they found out he had taken a risk by leaving the house, so he hasnt gone anywhere since. Once a week, hell sit in his car, turn the key and let the engine idle for five minutes just to keep it running.
Among those who cannot delay his next procedure is Jerry Deans, 71, who was diagnosed with prostate cancer in 1999 and has undergone a litany of treatments since.
Later this month, hell lie on a table for 30 minutes at the Sarah Cannon Cancer Institute in Henrico County while a focused beam of radiation is projected into the T12 vertebra of his spine and his left hip. If all goes well, he wont feel a thing, and he wont experience a single side effect.
But waiting was never an option. Putting off radiation would mean risking his bones fracturing and his spine collapsing.
It needs to be done, Deans said. Its not an emergency, but its pretty urgent.
Because the cancer institute is in a separate building from the hospital, he wont be treated under the same roof as COVID patients.
When the pandemic struck, Deans was undergoing chemotherapy treatments. He began taking precautions in January, wearing gloves and no longer hugging others, long before they became common practices.
When the radiation therapy is behind him, he and his wife, Patsi, and his dog, Zoey, will take their camper north to the Potomac River for a small vacation. Patsi and Zoey, he said, are his hugging partners.
Isolation might be the hardest part for Angela Bowman, 61. She misses having physical human contact, and theres a new baby in the family she hasnt met yet. Before the pandemic, shed walk the malls at Short Pump or Virginia Center Commons and window-shop. She enjoyed going to the grocery store and finding a good sale.
Her friends will bring her groceries and leave them on the front stoop, or she might sneak into a grocery store on the way home from her chemotherapy treatment for non-Hodgkins lymphoma. Her friends have reliably called and visited in creative ways.
Two friends parked their car in her driveway, and called on the phone so they could speak to her and see her at the same time. Another came for coffee and sat on the back deck, a good distance away.
For Jim Price, 65, life in lockdown is familiar. He learned to social distance in 2013, when he had a liver transplant. Thats when he realized the importance of washing his hands and avoiding touching public doorknobs.
For Jim Price, 65, life in lockdown feels familiar. Its similar to the summer of 2013, when he received a liver transplant and spent the next eight weeks at home. Few visitors were allowed to enter his home, and if they did, they were all asked to scrub their hands in Purell, which had been purchased in bulk from Costco.
In the years since, he has become adept at washing his hands longer and more often. He keeps small containers of hand sanitizer in his car. He avoids touching public doorknobs whenever possible.
To help his body accept its new organ, Price takes an anti-rejection medicine that suppresses his immune system. For the past two months, he has lived life the way he did after his transplant, staying home, watching Bonanza or The Andy Griffith Show on television and reading fiction by authors like Dean Koontz. He also works full time as a lumber salesman.
You get this gift, this opportunity to stay alive, Price said. So you want to limit the number of opportunities to screw up.
Thanks to the coronavirus, healthy people are seeing the world from the perspective of someone whos immunocompromised, said Faith Jones, 38, who was diagnosed with lupus when she was in college.
Because of her condition, shes prone to developing pneumonia. When she felt feverish and stopped breathing normally last month, she went to the University of Virginia to be tested for COVID. The test came back negative.
She wants people to know that when they stay at home, they arent just protecting themselves. They are protecting people like her, and they are protecting the elderly.
Its not just about you, she said.
The residents of Deltaville in Middlesex County have taken the pandemic seriously, said Anne Cooper, 68. The customers at the local market generally wear masks, and at the hardware store theres a Purell station and a sign that says Use it or leave. Campgrounds have remained closed to keep outsiders away. The average age in Middlesex, she said, is 58.
Cooper administers chemotherapy pills at home for her breast cancer, twice every morning and twice every evening. She visits the market once a week, but its easy to avoid crowds in Deltaville, she said.
Twice a week, she receives physical therapy for the sciatica in her spine that causes hip and leg pain. She waits in the parking lot until her name is called, walks directly to the treatment room and interacts only with the therapist attending to her.
Still, in the back of her mind, she wonders who the therapist has interacted with and what germs he or she might have caught.
Sometimes, it scares me that Ive survived cancer for 17 years, and this might kill me in four months, she said. I leave it in the hands of the Lord.
Originally posted here:
Those with compromised immune systems are the most vulnerable to COVID-19. They are also the most prepared. - Richmond.com
Art in the waiting room – The Spinoff
Megan Dunn takes a long look at the art in the Auckland Hospital collection and finds out that yes, there is art, even in intensive care but the price of seeing it is everything.
I got the pamphlet in the mail back in January. It says after someone close to you dies it is natural to:
The day the pamphlet arrived I splayed it open and looked at the photo inside: a network of hands holding other hands. Cropped close. Just linked hands held in support of one another. Beneath the photo: we grieve as deeply as we love.
I am unable to return to normal services.
Painting from collection donated by the Art Komiti of Aucklands Paremoremo Prison
I had noticed art in waiting rooms before, not art with a capital A, not the kind of art that an art writer such as myself would bother to write about, because art like so much else in our society has its hierarchy. Contemporary art is a high-stakes game; who you write about is as important as what you say. Who cares about the art in the waiting room? Lets abbreviate: who cares?
Me. Ive had cause to think about it because last year Mums cancer returned from outer space. Shed been in remission for 17 years, which might be a national record for multiple myeloma, a cancer of the blood. Ive never really understood what her cancer is, just that she beat it first time round, and, last July, the cancer cell count was up. Then she started chemo.
Im not coping, Im just not coping, Mum called after the first round, in tears.
Have you eaten anything?
No. I dont feel like eating.
It was the dex. The specialist, a blonde in a miniskirt and long black boots, said, Thatll be the dex. Short for dexamethasone, a steroid. Another bitter pill to swallow. At that point Mum had to take up to 10 pills a day. I looked at the specialist. I was angry. Mums not coping. I had flown to Auckland to join Mum for her next haematology appointment.
But what art could I prescribe? Optimism matters, but art isnt always soothing or kind.
Im lucky I have a chance of getting better, Mum said. True. Her prognosis was good.
We went upstairs for her second round of chemo. The nurse in blue gown, gloves and a shower cap wheeled it around in a mauve container, hooked it on a drip, and inserted the port into Mums vein.
Other patients stretched out on beds like La-Z-Boys, skin drained. They too were waiting, but looked like they didnt have a chance of getting better.
I stared into the little office next to Mums chair. Harried papers on the desk; a PC lit up like a bright face, ready to supply details, cheer, whatever counts most. On the wall, an original painting of a phutukawa tree. I call it original but the concept wasnt. The sea peeked out of the background, the sky bluer than the sea. The oils had been used with little mixing, but I didnt mind that painting of the beach in summer rudely lit up by the phutukawa tree, the needles burst open in the leaves, red as fireworks.
The nurses are very nice here, Mum said.
Niceness counts like stem cells it has a tally.
That was quick, I said.
It really doesnt take long.
I wondered how long the painting took the artist. Guessing from the paint application, not long, but longer than it takes a dose of chemo to run into your veins.
I wanted to ask the nurse: who bought that painting? Who is the artist? Who put that there? But I was too shy. Why stop this real raw moment, for an intellectual aside, a detour into the art we look at it when were waiting to get better or to see how much worse it can get?
The painting of the phutukawa tree in summer yields its bouquet. Just be.
***
Mum and I got lost en route to blood work. The hospital has an art collection in its corridors that must be maintained by someone, however irregularly. We passed a Claudia Pond Eyley print black lines of plants, bright colours, a Pacific infusion abandoned along a corridor. A trio of photographs of flowers. Where are we? Is it this the way? They need to give better directions. Then, in a gangway, a pair of large, textured, brown abstracts, neither good nor bad, just out of time, like photos of your parents when they were young, in the fashions of the day. Those sideburns. What chops! Mums perm. Dads flares. A big Pat Hanly painting called Vacation was by the escalator. I meant to come back, retrace my steps, and find all this art again. And I did come back, but by then everything had changed.
I dont want to write what comes next, because I dont want the wait to be over. Waiting is a comfort in its own sad way. Just wait and see.
The sea. Waves lap in and out. I see it whenever I attend my doctors surgery above Courtenay Place. Piha is by the Korean-born photographer Jae Hoon Lee. Its moved around the surgery over the years. Now its in the waiting room above a line of plastic chairs. Whoever bought it must have thought it was soothing and anaesthetic, a balm for a worried soul like mine.
What do you want to see when you go for a smear test, or hold a baby that wont go the fuck to sleep, or wait with your partner for test results, a prognosis, a new vaccine?
I thought Ill wait to write about the art at the doctors surgery or the hospital. Or the dentist, though I have not been to the dentist in ages, no cash, so Ill wait. How much art is in your life? How many fillings? Do you have art at home? If so, what? Where did you get it? At what price?
In the waiting room, I dont blame you if you dont want to look at something difficult and ugly or think about something hard. If youre just after a good view, Arent we all?
At my doctors surgery Pihahangs near a plastic container for pamphlets, ruffled in waves.
For every problem there is a pamphlet.
The pamphlet that arrived in the mail in January is titled Department of Critical Care Medicine Bereavement Follow-up Service.
Piha in situ at Courtenay Medical, Wellington
The waiting room isnt just literal, but it is literal too. I know because the last time I was there I got a hot chocolate from the machine. Warm, syrupy. No art, just a TV on the wall.
At the haematology department, I watched a dad sitting with his young daughter on his lap. Her mind looked far away. She waited with the patience of one who has waited before. Then her mum appeared in a turban. I looked at this young mother, I had no idea what cancer of the blood she had, but I really hoped she had a chance of getting better.
Two in 100 people die, Mum said. Back in December she was waiting for her stem-cell transplant. She would be in hospital for two to three weeks. The transplant would take her immunity to zero that was where the risk of infection crept in but then the white cells would ingraft and her count would go back up. Shed signed the forms, accepting the 2% chance she would die. If theres not a bed on Thursday, it will be next week.
I wondered: Will there be any art in her room? And if so, what will it say?
The phutukawa painting in the office of the haematology department says shush shush, that lulling noise of waves from the beach. Dont worry, relax. Its OK. Look at the view. But the Jae Hoon Lee photograph in my doctors surgery says to me your hurt is timeless, the sea will exist whether we do or not, release your grip, whatever happens next will be surgically safe, emotions are never still, time is an inlet, the sea runs in and out.
***
I always knew that waiting was part of the problem. What if you wait too long? Then you cant get around to what you were going to say because you are:
***
Outside Ward 82, ICU (acute surgery). On the intercom, the number one has been buzzed off, pushed too many times. All other numbers present and correct. My mother is in bed 17, I tell the intercom, after Ive pressed the number one that isnt there and waited. Then I walked through vaguely yellow corridors lined with three framed prints, each composition a rectangle yellow, blue, orange lined with holes down the middle. They reminded me of paeans to the common household sponge. I stop at the hand-gel pump and sanitised. The art at the hospital is sanitised too but Im beyond caring. Too much caring and you move though it and pass out on the other side somewhere in the vicinity of bed 17.
At the end of the corridor past the hand gel, the Chen family have donated a small square print, red with black scribble, in honour of the ICU team. I clocked the gold engraved plaque, their appreciation registered on the wall. The painting not unlike the size of a fire alarm, but there is no glass to break open, the call has already been raised.
I got the call from the registrar on December 22 to say that Mums stem-cell plant was not going as expected and she had been admitted to ICU.
Ive been thinking about what I will do when I get better, Mum said, the night I arrived. She sat propped up in bed, on oxygen. Her face flushed, swollen, but superficially OK.
I sat next to her bed. Oh yes, what do you think?
Im going to come to your book launch.
I smiled. My book of personal essays about art and life, already way behind schedule.
What else? I asked.
I might meet someone new. I might travel.
Where would you like to go? I asked.
She paused. Maybe Africa, she said. I could go on a safari.
I nodded. Mum found it hard to walk up the small pronounced hill to our house in Wellington, sweated easily, mopped her forehead. Then shed wait, slightly panting, for her breath to right itself again, restart.
That night, I slept in the hospital. They say you can stay in my room at the Motutapu Ward, Mum said. There was no art in her room, but a wall-to-ceiling poster of a forest, kauri trees, dense, shady, green.
In the morning I got buzzed back into ICU. Mums arms and legs, twitched, calling out; face red, body puffed up; trying to unpick the PICC line from her arm, in among the beeping and the rising heart monitor, the oxygen exhaling. She doesnt recognise me, is raving to the charge nurse, who held her hand and looked at me and explained, Im just going some gentle reorientation work.
I must have seemed stunned.
Do you want to speak outside the room? the charge nurse asked.
I nodded. In the room next door to bed 17, I wailed, What is happening? Oh, what is happening? The charge nurse held me in place and comforted me, when there was no comfort to give.
Next the intensivist arrived in her blue scrubs, removed her surgical mask, wiped her hands with gel, introduced herself as Kylie. She wanted a family meeting.
The whnau room: the painting was donated by the Art Komiti of Aucklands Paremoremo Prison
The whnau room at ICU contains another Claudia Pond Eyley print on one wall and a multi-panel painting of a New Zealand landscape on the other. The mountains, a lake, smooth and even and still. A perennial view of nature, so calm, so undisturbing to see. I cant blame the hospital for containing so many paintings of the view sky, sand, sea, soothing, stretching, somehow infinite. A vista of comfort, comprehended.
I sat down on one side of the big meeting table, Kylie on the other. What is your understanding of your mothers condition? she asked. I rattled off the facts while an accompanying nurse took notes.
Mum had come in for a stem-cell transplant. She had caught pneumonia at a point in the process when she had no natural immunity. She had developed delirium. Her pre-existing heart condition had been set off: arterial fibrillation. She needed oxygen support to breathe.
This is what the 2% of risk looks like? I asked.
Yes. Kylie explained that they couldnt provide sedatives like morphine as that would risk compromising Mums breathing further. They could put Mum on a ventilator if she deteriorated but that would not be a good sign and would come with an extra level of risk. What helped patients with delirium was familiar voices.
I asked her, Are you holding anything back?
Just that this is very life threatening. Her eyes, an expression, I can now only call grave.
Well, it seemed apt. I liked Kylie. The intensivist understood how much intensity was required.
The job title intensivist seemed funny to me because in high school I was always told I was too intense. We have to find a happy medium, a teenage girlfriend once told me. So I got into art because it seemed like a place where intensity went and didnt have to turn down a notch. But art isnt the only place for intensity. At the intensive care unit (acute) on the eighth floor of Auckland Hospital the intensivists are also at work.
All day the nurse at bed 17 and I spooned jelly or orange juice into her mouth, helped her not frantically unpick her PICC line, I just want to go for a walk! No, no dear, you cant get up. Mum, you just need to rest. Rest. A familiar voice on replay. Youll feel so much better if you rest.
In the night I noticed the print of a lone bugle boy down some New Orleans alley, presumably playing jazz. No plaque. Who bought it? What family? Who was lost?
In ICU the beeping was persistent, insistent. The constant sound of inhaling, exhaling. Poke your tongue out. Ahhhh. Good girl.
Were concerned about the delirium. In ICU, delirium can be intensified, especially in older people, by the strange sounds, lights, faces.
I forgot the ducks! I keep meaning to mention the duck painting, a watercolour, a good one too, of some ducks paddling around their pond, giving no quacks in ICU. The duck pond was donated by another family, with a brass plaque. I should have jotted down the name.
The eyeball is so moveable, up and over, it can even see things that arent there. Mum said her family prayer, over and over, eyes roving. We consecrate to Thee, O Jesus of Love My aunt clutched her hands and said the prayer with her.
One night in ICU I passed a large rectangular collage of brightly coloured red and pink buttons like some budget Damien Hirst pill painting. Never passed it again. Beep, beep.
Her oxygen levels are saturating nicely.
How much?
Fifty-five percent, then down to 48%.
Dont obsess about the blood count.
Look at the patient. Look at the face.
The face her not her.
My daughter in the car on the way to the hospital singing: Pop bang crack goes the Christmas cracker, pop bang, crack goes the Christmas cracker, we will pull it off POP.
Eyes popped, snapped.
Shes been restless.
You need to sleep.
Sleep.
I stop and start, keep typing the next line, then deleting it. I dont want to get to the end of this. I dont want to remember all the family meetings in the whnau room waiting. I dont want to chart the order of those disordered days.
What was I going to say about art?
***
I spent the first weekend after Mums stem-cell transplant in her room at the Motutapu Ward. Motutapu means sacred or sanctuary. Shed just had the big dose of chemo and was quiet, but not yet unwell. My aunt was going to join her on Monday Mums 69th birthday for what would be the worst week of the process. I sat on the bed, Mum on the La-Z-Boy. We said not a whole lot.
At one point, I think I can manage a walk.
We passed the two nurses stations. En route I pointed out the art. We stopped by a faded print of sunflowers, beneath glass, but the artist was no Van Gogh. The first time Id passed the sunflowers, I hadnt rated them at all. But that was before Id read that they were by Chris Corlett, a 17-year-old who died of acute lymphoblastic leukaemia 20 years ago. Sunflowers of Hope does look like it was painted by a teenage boy. Theres something gnarly about them. Large and abundant. Full of life. Except for the leaves Chris paid special attention to the leaves stippled with decay, a bit heavy metal.
Sunflowers of Hope, Chris Cortlett, Auckland Hospital, 2019.
We stood reading the accompanying framed text about the foundation Chris had started to build up a database of 100,000 bone-marrow donors.
Courage, charisma, strength of character, sincerity whatever it is that makes some people inspirational and very special, Chris Corlett had it.
Another Claudia Pond Eyley print near the kitchen and on the door a sign that read: Dont use if youre come from a red room. I was confused by it when Id made Mum a cup of tea earlier and had to ask the nurse, Is this a red room? (Mums room was not a red room.)
I felt the light weight of Mums hand on my arm as we looped around to reception. I showed her my favourite painting, tucked in a corner. Its colours were so bold that from the corner of my eye I first suspected Matisse. Then was embarrassed when I realised the artist is Harriet, aged six, who donated Flowers for the Leukaemia Ward in memory of her father, Ned.
Harriet may not be Matisse but for a six-year-old her vase of flowers is a masterpiece of colour and compression.
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Art in the waiting room - The Spinoff
Sapelo Skin Care Combines High-Tech Ingredients and Southern Charm – Sarasota
Sapelo Skin Care is one of those brands you'll love for a lifetime. Not only is it luxe, the products are also wrapped in the loveliest packaging, with designs that make me think of a beautifulobjetfound in a well-appointed Southern mansion. So it should be no surprise to learn that the brand is handmade in Savannah. Founders Stephanie Duttenhaver and Cindy Edward took note of the city's natural beauty, especially the rivers and creeks that swell with high tides twice each day, and followed those cues to craft a small-batch, non-toxic product. The twice-daily tinctures soothe and replenish the skin, boosting collagen, elastin and skin-cell restoration to give us the healthy glow we all want (especially as we spend more time indoors).
I gave four Sapelo products a go: the Gentle Seaweed Cleanser ($40), Milk & Honey Hydrating Mask ($75), Restoring Eye Serum ($95) and Spring Tide Serum ($195). I loved them all, and I will be returning to Saks Fifth Avenue at the Mall at University Town Centerwhich reopens with limited hours on May 12for a moisturizer to complete my regimen.
The cleanser sets the foundation for the serums, leaving the skin feeling clean and oh-so velvety. And the serums are heavenly, with bottles dispense the perfect droplet of product. They're clearly designed by women who know we do not like to waste a good thing.
Then there's the Milk & Honey Hydrating Mask, another winner. After all the ups and downs of our Sarasota temperatures these last months, my skin needed a little love and felt re-textured and re-hydrated after using the mask.
Now, it may just be me, a woman from New York, who feels that Southern woman knowthings. Such as how to deliver the hard truth with a smile (and you may even thank them for it). Or how to set a proper table for tea. Or in this case, the secret to aging gracefully.
So I had to know why Sapelo is so wonderful. Well, first, it is created in a pristine lab under careful supervision. There, Duttenhaver and Edward marry bio-active, Southern-inspired ingredients with a scientific system that mimics our body's natural healing process. It's my favorite kind of skincare: nature and science combined with cruelty-free ingredients, formulated without fillers, silicone, parabens, sulfates, GMOs, triclosan or petrochemicals.
What's more, Sapelo's formulations are a botanical profusion of gardenia stem cells, magnolia oil, oyster shell calcium, seaweed, essential oils and Georgia honey. Sigh. Now I'm craving a cold glass of sweet tea and a front porch.
Let's turn to Duttenhaver and Cindy Edwards for a quick Q&A.
Cindy Edwards: Sapelo Skin Care is named after one of the beautiful, largely undisturbed, and under-developed barrier islands off of the coast of Savannah, Georgia. It is a nod to our inspiration of nature and heeding lessons from generations of southern women to be gentle with our skin.
Stephanie Duttenhaver: Cindy and I both were looking for an authentic anti-aging strategy for our skin. We were seeing the first signs of aging, partly due to the effects of decades of southern sun exposure and to our unavoidable hormonal milestones! We were frustrated by the mediocre results of potions and lotions sold in luxury stores but were also wary of the quick-fix, invasive solutions, like dermabrasion, acid peels, and laser and light therapies.
My husband, a radiation oncologist, challenged me once with this comment: "When a radiation oncologist creates a laser burn on a cancer patient's skin, it's called a complication. But when skin is burned in a medical spa, clients pay for it. Does that make sense?"
The penny droppedmost mainstream dermatological procedures create damage to the skin; likewise, so do prestigious skincare brands containing retinoids and other acids. We realized that these strategies had one thing in common: creating havoc in the skin through damage and injury, then relying on the injury to recruit the body's immune system response to initiate repair and renewal.
When your skin is injured, your body releases a cascade of healing peptides, proteins, vitamins, and minerals to rebuild the damaged cells. We began to look at that cascade and wondered if we could replicate the restorative cascade in a skin care regimen that topically infused the same cascade but without the damage. It was at that moment we started to formulate the philosophy behind Sapelo Skin Care.
After three years of research, counsel with physicians and chemists, and the unerring support of friends and family, we launched our Three-Step Skin Recovery System. It is a gentle, stand-alone regimen that mimics our body's natural immune system response to injury but without the injury.
CE: We spent almost three years developing a product that nurtures and rejuvenates the skin gently and naturally by using Southern-inspired ingredients including gardenia stem cells, magnolia oil, oyster shells, Atlantic seaweed, bio-active peptides and micro-nutrients. We committed ourselves to only using the highest-quality ingredients in the highest quantity in our products.
For example: In our Renewing Serum, we use more than 4 percent hylauronic acid (HA) and a combination of three separate HAs at different molecular weights in order to flood the skin and really get down to all of the layers of the dermis, where new cells are produced.
SD: Relying on skin-damaging procedures and retinols as your anti-aging strategy. Our skin has an amazing capacity to heal, but that capacity is not unlimited. With repeated injury to your skin, year after year, your skin will thin we believe it leads to accelerated aging.
SD: Don't use acids to exfoliate your skin; use enzymes. Acids burn the skin, whether they are dead surface cells or healthy ones. But enzymes "eat" dead skin and leave healthy skin alone. Once you have removed the dead skin, that encourages a healthy environment for your complexion. I also do not like face scrubs. Use a soft cotton washcloth (I love baby washcloths!) to gently cleanse and remove dead skin.
SD: I love breakfast smoothies. Most mornings I will blend my favorite fruits, yogurt, cranberry juice, chia seeds and a collagen powder, which is full of peptides and amino acids, to make my daily concoction. My favorite collagen supplement is Beauty Collagen by Vital Proteins. It was developed to support collagen and hyaluronic acid production in the skin and hair. And it is manufactured in the U.S.that means a lot to me- especially in today's environment.
SD: Never turn down an opportunity to introduce or present your company's philosophy to an individual or group. As women, we are multitaskers and always juggling work, home, family and social connections. Cindy and I are no exceptionwe wonder how can we squeeze one more engagement into our day. The extra preparation and time you spend presenting your business at a small gathering or a grand occasion can often feel unwelcome or inconsequential. However, we have learned over and over again that every time we put energy out into the world, something of value always comes back to us, and that keeps us motivated and moving forward.
Sapelo Skin Care is available at Saks Fifth Avenue, 120 University Town Center Drive, Sarasota. The store is offering curbside service for purchases, returns, exchanges and alterations between 12-4 p.m., and plans to reopen to the public with limited hours12-6 p.m.on May 12. Call (941) 364-5300 for more information.
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Sapelo Skin Care Combines High-Tech Ingredients and Southern Charm - Sarasota
11 Skincare Products To Try Now Injectables Are Off The Cards – British Vogue
Youve probably seen those before-and-after quarantine memes, the ones featuring faces or more specifically, lips that have undergone a drastic change in shape in the absence of access to an aesthetician. Exaggerated they might be, but it is true that lockdown has left an injectable-shaped hole in some of our lives, and whether youre into them or not, our newly facial-free (and less-than-active) lifestyles are wreaking a certain amount of havoc on our skin anyway. For those who have regular in-clinic treatments, lockdown can mean that lines start to show, full lips diminish, cheeks depress and sunken eye sockets and dark circles re-appear, says aesthetic doctor Dr Sophie Shotter, who has temporarily shuttered her clinic and returned to the NHS frontline to join the fight against Covid-19. And, while the issue might seem trivial in light of everything else going on in the world, it is possible to harness the power of intelligent skincare to help mimic the effects of filler and Botox in lieu of the real thing. Dr Shotter shares her tips here.
Filler is routinely administered to add volume to the skin, usually in the face, says Shotter, who explains that its made from hyaluronic acid, a molecule we should all be utilising in our skincare routines to help soften fine lines. One of the best serums for the job is SkinCeuticals HA Intensifier, which boosts hyaluronic acid levels in the skin, making it look and feel firm, plump and hydrated. Alternatively, try LOrals Revitalift Filler Hyaluronic Acid for a more affordable option.
To smooth skin, Shotter also recommends BioEffect EGF Serum, which boosts skin thickness and collagen levels in the skin, meaning fewer wrinkles and a healthy glow. And finally, look to SkinBetter Science AlphaRet Overnight Cream to reap the benefits of prescription strength vitamin A (otherwise known as retinol): Retinol is the ultimate age management molecule that increases collagen levels, she says.
If youve had Botox before, you will know that its a toxin injected where there are dynamic lines to relax them and remove creases within the skin, says Shotter. There are products that mimic its effects: Meder Skincare Myo-Fix Concentrate, is full of muscle-relaxing peptides that work to block the nerve communicating with the muscle. Although it might sound daunting, its totally safe to use, and Shotter recommends regular and sustained use for the best results. Another great product to use if you usually have Botox administered superficially to regulate oil production is Institut Esthederms Pure System Pore Refiner Concentrate it is silicone based so refines their appearance beautifully.
Used religiously, there are products that can help to lift and plump the lips, although, like all of the products listed here, they wont have effects on a par with the treatment itself. One of the best to try is Fillerinas Lip Volume Grade 3, which contains six different hyaluronic acid molecules of varying weights and sizes, to deeply hydrate lips and give a fuller effect with continual use. Shotter also recommends a brilliant lip balm. Medik8s Mutiny Squalane Lip Balm helps to nourish and heal the lips, drawing moisture to the area to give them a plumper, more hydrated look, she says, adding that its important to use SPF to protect them from collagen-depleting UV rays. Protecting the health of the lips will help them stay plump and full.
Filler is often strategically placed to fill the hollows under the eyes, to refresh and hydrate and to lift dark circles, says Shotter. A (plant-based) stem cell serum, like Dr Levy Intense Stem Cell Eye Booster Concentrate, will boost the thickness of the delicate under eye skin, plus it also contains retinol and antioxidants to smooth fine lines and brighten the area. MGC Dermas CBD Stem Cells and Peptides Eye Cream is a brilliant option too, thanks to firming peptides, hyaluronic acid and calming CBD.
More from British Vogue:
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11 Skincare Products To Try Now Injectables Are Off The Cards - British Vogue
Terminally-ill teen with agonizingly-sensitive skin defies doctors to live to 19 – Metro.co.uk
Marky Jaquez, 19, has recessive dystrophic epidermolysis bullosa, a condition found in fewer than one in one million newborns. (Picture: Melissa Jaquez/Metro.co.uk)
A teenager whose rare skin disorder means that even the slightest touch leaves him in extreme pain has defied doctors predictions to live to adulthood. Marky Jaquez, from Wichita, Kansas, cannot hug his parents, wear clothes or even walk because any friction causes layers of skin to peel away from his body.
Wheelchair-bound, Marky, 19, has never been able to walk because the ground would shred his feet like a cheese grater and must be covered head-to-toe in bandages to protect his fragile skin from tearing. He has recessive dystrophic epidermolysis bullosa, a condition found in an estimated one in one million newborns that often leads to life-threatening skin infections and even cancer.
The illness is caused by a faulty gene, passed onto children by parents. Tragically, Markys brother Carlos was born with it too, and died aged just 14. Doctors warned Markys parents he was unlikely to live beyond the age of 11, but he defied that grim prediction and will celebrate his 20th birthday later this year.
His mom, Melissa Jaquez, 40, said: Marky only has one layer of skin and because of his genetic makeup, the skin has no way of anchoring itself the body. Any form of touch or friction means his skins just tears away.
Its world shattering to think I will lose both of my boys to this and I dont want to think about what life will be like afterwards. I feel like my purpose in life is to give Mary the best life I can for the time that I have him.
I am not able to hug my son because any friction just causes his skin to come away and tear right off. It causes him excruciating pain and I feel so much guilt, but theres nothing I can do to help him.
But despite all of this he is a very happy and joyful boy and he amazes me every single day. Hes an inspiration and proves to everyone that you can keep going with whatever youre going through, no matter how bad it is.
Marky is the youngest of three brothers born to healthcare worker, Melissa. Eldest son Michael is 24, with Carlos dying of heart failure caused by the skin condition in 2015. Marky and Carlos, who would be 21 this year, were both born with the same condition after inheriting a faulty gene from their parents.
Melissa said doctors suspect both she and the boys father carry the faulty gene that causes the genetic mutation. Although both are unaffected themselves, they have an estimated 25% chance of having a child born with recessive dystrophic epidermolysis bullosa. Melissa has since split up with Marky and Carlos father neither of whom knew they carried the faulty gene until Carlos was born, she said.
Melissa said she became aware of the risks involved with having a child after Carlos was born, but claims she was told by a clinician that the chance of her having a second child with the same condition would be less than 1%.
Melissa said: I lost Carlos to the condition because his heart just gave up. His body was in a constant battle to repair his wounds and that took its toll eventually.
His condition was much more progressive than Markys. He got real bad, real quick and by the end could not even breathe on his own.
My pregnancy with Marky was unplanned, but when I got pregnant I was told the chance of me having another baby with the same condition is 1%. They said having two children with it is unheard of.
Marky was born with the most severe type of epidermolysis bullosa meaning he was delivered without skin on his hands, feet and chest because because of the friction of childbirth.
Ever since Marky was little, Melissa, who is now married to Marcos, 30, has had to spend up to three hours a day covering his skin in protective bandages and cleaning open wounds to prevent infection.
She has said every day of motherhood so far has felt like a battle and admits she has struggled to have a normal mother and son relationship with Marky, because of his condition.
Every day is such a massive challenge for us. I struggle with the grief of knowing that when I walk into my sons room in a morning, we cant have fun. I dont get to do the normal things that a mom and a son does.
Instead when I go into his room I know I have to cause him pain and spend two hours doing his bandages. That does give me a lot of anxiety and guilt.
Taking his bandages off does cause excruciating pain. We have to soak his skin every day to soothe his wounds and give him pain medication. Its incredibly upsetting for me.
Whilst there is no cure for epidermolysis bullosa and Marky is highly likely to sadly one day lose his life to the condition, Melissa is hopefully he will survive for several more years.
He has been selected to take part in experimental treatment to create genetically modified skin stem cells that can slow down the effects of the progressive disease. The family plan to travel to Stamford Hospital, Connecticut, later this year to undergo the treatment.
Melissa and Marcos work opposite shifts and have a carer who comes to help look after Marky for three hours each day. Melissa has paid tribute to her amazing son, who she believes can go on to live for many happy years, despite the predictions of doctors.
She said: The treatment at Stamford could add several years to his life. It will reduce the pain and make it easier for his body to cope.
We have tried for that treatment for years, so were thrilled.
Marky has always been an incredibly happy boy and he has just got on with it, without ever moaning or saying why me. Ive had messages from people all over the world to say Marky has inspired them.
Hes an amazing human being and he makes me so proud.
Go here to read the rest:
Terminally-ill teen with agonizingly-sensitive skin defies doctors to live to 19 - Metro.co.uk
Top 10 Best The Body Shop Anti Aging Body Creams 2020 – Best gaming pro
This story was initially printed 2020/03/19 9:55am PDTon Mar 19, 2020 and final up to date 2020/05/08 11:34am PDTCould eight, 2020.
Again at F8 2019, Fb promised a redesign for its cellular apps and web site. The Android app began receiving the brand new interface nearly instantly, however the change was solely promised on the net in the following few months. Now, it is beginning to roll out and together with it comes a brand new darkish mode possibility.
For the previous few days, many users have reported that they received prompted by Fb to check out the brand new interface. After accepting, they get requested in the event that theyd like to make use of the white or darkish structure. The selection can also be out there underneath the fast settings accessible from the highest proper avatar.
Picture credit score: @teepusahab, @kimsantoshansen
After all, the brand new design isnt universally liked, and it even has issues with text readability in a few dark mode screens. However that is the worth of any early launch.
If you arent getting prompted by Fbs web site to attempt the brand new look, there does not appear to be any workaround to force-trigger it simply but.
Rolling out to more users
The new Facebook web UI with the dark theme seems to be rolling out widely. Thanks, Anurag Dalmia!
Facebook announcement
Based on the reports we received, it was clear that Facebooks new look was already being widely deployed, but today the company has put the final pin in this story by formally announcing the UI overhaul.
In a news post, Fb discusses its planning and analysis efforts that went in to designing the brand new interface. Not everybodys been a fan of those modifications, however at the very least we are able to hear Fb out on why it thinks this new look is superior.
Excerpt from:
Top 10 Best The Body Shop Anti Aging Body Creams 2020 - Best gaming pro
ROCKET PHARMACEUTICALS : Management’s Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) – marketscreener.com
You should read the following discussion and analysis of our financial conditionand results of operations together with the condensed consolidated financialstatements and related notes that are included elsewhere in this QuarterlyReport on Form 10-Q and our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2019 filed with the U.S. Securities and Exchange Commission, or theSEC, on March 6, 2020, or our 2019 Form 10-K. This discussion containsforward-looking statements based upon current plans, expectations and beliefsthat involve risks and uncertainties. Our actual results may differ materiallyfrom those anticipated in these forward-looking statements as a result ofvarious factors, including, but not limited to, those discussed in the sectionentitled "Risk Factors" and elsewhere in this Quarterly Report on Form 10-Q. Inpreparing this MD&A, we presume that readers have access to and have read theMD&A in our 2019 Form 10-K, pursuant to Instruction 2 to paragraph (b) of Item303 of Regulation S-K. Unless stated otherwise, references in this QuarterlyReport on Form 10-Q to "us," "we," "our," or our "Company" and similar termsrefer to Rocket Pharmaceuticals, Inc.
We are a clinical-stage, multi-platform biotechnology company focused on thedevelopment of first, only and best-in-class gene therapies, with directon-target mechanism of action and clear clinical endpoints, for rare anddevastating diseases. We currently have three clinical-stage ex vivo lentiviralvector ("LVV") programs currently enrolling patients in the US and EU forFanconi Anemia ("FA"), a genetic defect in the bone marrow that reducesproduction of blood cells or promotes the production of faulty blood cells,Leukocyte Adhesion Deficiency-I ("LAD-I"), a genetic disorder that causes theimmune system to malfunction and Pyruvate Kinase Deficiency ("PKD"), a rare redblood cell autosomal recessive disorder that results in chronic non-spherocytichemolytic anemia. Of these, both the Phase 2 FA program and the Phase 1/2 LAD-Iprogram are in registration-enabling studies in the US and EU. In addition, inthe US we have a clinical stage in vivo adeno-associated virus ("AAV") programfor Danon disease, a multi-organ lysosomal-associated disorder leading to earlydeath due to heart failure. Finally, we have a pre-clinical stage LVV programfor Infantile Malignant Osteopetrosis ("IMO"), a genetic disorder characterizedby increased bone density and bone mass secondary to impaired bone resorption -this program is anticipated to enter the clinic in 2020. We have globalcommercialization and development rights to all of these product candidatesunder royalty-bearing license agreements. Additional work in the discovery stagefor an FA CRISPR/CAS9 program as well as a gene therapy program for the lesscommon FA subtypes C and G is ongoing.
Recent Developments
On February 20, 2020, we entered into separate, privately negotiated exchangeagreements (the "Exchange Agreements") with certain holders of our outstanding5.75% Convertible Senior Notes due 2021 (the "2021 Convertible Notes") to extendthe maturity date by one year. Pursuant to the Exchange Agreements, we exchangedapproximately $39.35 million aggregate principal amount of the 2021 ConvertibleNotes (which represents approximately 76% of the aggregate outstanding principalamount of the 2021 Convertible Notes) for (a) approximately $39.35 millionaggregate principal amount of 6.25% Convertible Senior Notes due August 2022(the "2022 Convertible Notes") (an exchange ratio equal to 1.00 2022 ConvertibleNote per exchanged 2021 Convertible Note) and (b) $119,416 in cash to pay theaccrued and unpaid interest on the exchanged 2021 Convertible Notes from, andincluding, February 1, 2020 to February 20, 2020. The 2022 Convertible Noteswere issued in private placements exempt from registration in reliance onSection 4(a) (2) of the Securities Act of 1933, as amended (the "SecuritiesAct"). Upon completion of the exchange transactions, approximately $12.65million aggregate principal amount of 2021 Convertible Notes remainedoutstanding.
Gene Therapy Overview
Genes are composed of sequences of deoxyribonucleic acid ("DNA"), which code forproteins that perform a broad range of physiologic functions in all livingorganisms. Although genes are passed on from generation to generation, geneticchanges, also known as mutations, can occur in this process. These changes canresult in the lack of production of proteins or the production of alteredproteins with reduced or abnormal function, which can in turn result in disease.
Gene therapy is a therapeutic approach in which an isolated gene sequence orsegment of DNA is administered to a patient, most commonly for the purpose oftreating a genetic disease that is caused by genetic mutations. Currentlyavailable therapies for many genetic diseases focus on administration of largeproteins or enzymes and typically address only the symptoms of the disease. Genetherapy aims to address the disease-causing effects of absent or dysfunctionalgenes by delivering functional copies of the gene sequence directly into thepatient's cells, offering the potential for curing the genetic disease, ratherthan simply addressing symptoms.
We are using modified non-pathogenic viruses for the development of our genetherapy treatments. Viruses are particularly well suited as delivery vehiclesbecause they are adept at penetrating cells and delivering genetic materialinside a cell. In creating our viral delivery vehicles, the viral (pathogenic)genes are removed and are replaced with a functional form of the missing ormutant gene that is the cause of the patient's genetic disease. The functionalform of a missing or mutant gene is called a therapeutic gene, or the"transgene." The process of inserting the transgene is called "transduction."Once a virus is modified by replacement of the viral genes with a transgene, themodified virus is called a "viral vector." The viral vector delivers thetransgene into the targeted tissue or organ (such as the cells inside apatient's bone marrow). We have two types of viral vectors in development, LVVand AAV. We believe that our LVV and AAV-based programs have the potential tooffer a long-lasting and significant therapeutic benefit to patients.
Gene therapies can be delivered either (1) ex vivo (outside the body), in whichcase the patient's cells are extracted and the vector is delivered to thesecells in a controlled, safe laboratory setting, with the modified cells thenbeing reinserted into the patient, or (2) in vivo (inside the body), in whichcase the vector is injected directly into the patient, either intravenously("IV") or directly into a specific tissue at a targeted site, with the aim ofthe vector delivering the transgene to the targeted cells.
We believe that scientific advances, clinical progress, and the greaterregulatory acceptance of gene therapy have created a promising environment toadvance gene therapy products as these products are being designed to restorecell function and improve clinical outcomes, which in many cases includeprevention of death at an early age.
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The chart below shows the current phases of development of Rocket's programs andproduct candidates:
LVV Programs. Rocket's LVV-based programs utilize third-generation,self-inactivating lentiviral vectors to target selected rare diseases.Currently, Rocket is developing LVV programs to treat FA, LAD-I, PKD, and IMO.
Fanconi Anemia Complementation Group A (FANCA):
FA, a rare and life-threatening DNA-repair disorder, generally arises from amutation in a single FA gene. An estimated 60 to 70% of cases arise frommutations in the Fanconi-A ("FANCA") gene, which is the focus of our program. FAresults in bone marrow failure, developmental abnormalities, myeloid leukemiaand other malignancies, often during the early years and decades of life. Bonemarrow aplasia, which is bone marrow that no longer produces any or very few redand white blood cells and platelets leading to infections and bleeding, is themost frequent cause of early morbidity and mortality in FA, with a median onsetbefore 10 years of age. Leukemia is the next most common cause of mortality,ultimately occurring in about 20% of patients later in life. Solid organmalignancies, such as head and neck cancers, can also occur, although at lowerrates during the first two to three decades of life.
Although improvements in allogeneic (donor-mediated) hematopoietic stem celltransplant ("HSCT"), currently the most frequently utilized therapy for FA, haveresulted in more frequent hematologic correction of the disorder, HSCT isassociated with both acute and long-term risks, including transplant-relatedmortality, graft versus host disease ("GVHD"), a sometimes fatal side effect ofallogeneic transplant characterized by painful ulcers in the GI tract, livertoxicity and skin rashes, as well as increased risk of subsequent cancers. Ourgene therapy program in FA is designed to enable a minimally toxic hematologiccorrection using a patient's own stem cells during the early years of life. Webelieve that the development of a broadly applicable autologous gene therapy canbe transformative for these patients.
Each of our LVV-based programs utilize third-generation, self-inactivatinglentiviral vectors to correct defects in patients' HSCs, which are the cellsfound in bone marrow that are capable of generating blood cells over a patient'slifetime. Defects in the genetic coding of HSCs can result in severe, andpotentially life-threatening anemia, which is when a patient's blood lacksenough properly functioning red blood cells to carry oxygen throughout the body.Stem cell defects can also result in severe and potentially life-threateningdecreases in white blood cells resulting in susceptibility to infections, and inplatelets responsible for blood clotting, which may result in severe andpotentially life-threatening bleeding episodes. Patients with FA have a geneticdefect that prevents the normal repair of genes and chromosomes within bloodcells in the bone marrow, which frequently results in the development of acutemyeloid leukemia ("AML"), a type of blood cancer, as well as bone marrow failureand congenital defects. The average lifespan of an FA patient is estimated to be30 to 40 years. The prevalence of FA in the US and EU is estimated to be about4,000, and given the efficacy seen in non-conditioned patients, the addressableannual market opportunity is now thought to be in the 400 to 500 range.
We currently have one LVV-based program targeting FA, RP-L102. RP-L102 is ourlead lentiviral vector based program that we in-licensed from Centro deInvestigaciones Energticas, Medioambientales y Tecnolgicas ("CIEMAT"), whichis a leading research institute in Madrid, Spain. RP-L102 is currently beingstudied in our sponsored Phase 2 registrational enabling clinical trialstreating FA patients initially at the Center for Definitive and CurativeMedicine at Stanford University School of Medicine ("Stanford") and HospitalInfantil de Nino Jesus ("HNJ") in Spain. The Phase 2 portion of the trial isexpected to enroll ten patients total from the U.S. and EU. Patients willreceive a single IV infusion of RP-L102 that utilizes fresh cells and "ProcessB" which incorporates a modified stem cell enrichment process, transductionenhancers, as well as commercial-grade vector and final drug product.
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Table of ContentsIn October 2019, at the European Society of Cell and Gene Therapy ("ESGCT") 2019Annual Congress, long-term Phase 1/2 clinical data of RP-L102, from the clinicaltrial sponsored by CIEMAT, for FA "Process A", without the use of myeloablativeconditioning was presented demonstrating evidence of increasing and durableengraftment leading to bone marrow restoration exceeding the 10% thresholdagreed to by the FDA and EMA for the ongoing registration-enabling Phase 2trial. In patient 02002, who received what we consider adequate drug product,hemoglobin levels are now similar to those in the first year after birth,suggesting hematologic correction over the long term.
During the third quarter of 2019, we received alignment from the FDA on thetrial design and the primary endpoint. This alignment was similar to thatpreviously received from the European Medicines Agency ("EMA"). Resistance tomitomycin-C, a DNA damaging agent, in bone marrow stem cells at a minimum timepoint of one year to serve as the primary endpoint for our Phase II study. InDecember 2019, we announced that the first patient of the global Phase 2 studyfor RP-L102 "Process B" for FA received investigational therapy. There will betotal of 10 patients enrolled in the global Phase 2 studies.
In December 2019, we also announced preliminary results from two pediatricpatients treated with "Process B" RP-L102 prior to development of severe bonemarrow failure in our Phase 1 trial of RP-L102 for FA. To evaluate transductionefficiency, an analysis of the proportion of the MMC-resistant colony formingcells was conducted and both patients have thus far exhibited early signs ofengraftment, including increases in blood cell lineages in one patient. Nodrug-related safety or tolerability issues have been reported.
Leukocyte Adhesion Deficiency-I (LAD-I):
LAD-I is a rare autosomal recessive disorder of white blood cell adhesion andmigration, resulting from mutations in the ITGB2 gene encoding for the Beta-2Integrin component, CD18. Deficiencies in CD18 result in an impaired ability forneutrophils (a subset of infection-fighting white blood cells) to leave bloodvessels and enter into tissues where these cells are needed to combatinfections. As is the case with many rare diseases, true estimates of incidenceare difficult; however, several hundred cases have been reported to date.
Most LAD-I patients are believed to have the severe form of the disease. SevereLAD-I is notable for recurrent, life-threatening infections and substantialinfant mortality in patients who do not receive an allogeneic HSCT. Mortalityfor severe LAD-I has been reported as 60 to 75% by age two in the absence ofallogeneic HCST.
We currently have one program targeting LAD-I, RP-L201. RP-L201 is a clinicalprogram that we in-licensed from CIEMAT. We have partnered with UCLA to leadU.S. clinical development efforts for the LAD-I program. UCLA and its Eli andEdythe Broad Center of Regenerative Medicine and Stem Cell Research is servingas the lead U.S. clinical research center for the registrational clinical trialfor LAD-I, and HNJ is serving as the lead clinical site in Spain.
The ongoing open-label, single-arm, Phase 1/2 registration enabling clinicaltrial of RP-L201 has dosed one severe LAD-I patient in the U.S. to assess thesafety and tolerability of RP-L201. The first patient was treated with RP-L201in third quarter 2019. This study has received $6.5 million CLIN2 grant awardfrom the California Institute for Regenerative Medicine ("CIRM") to support theclinical development of gene therapy for LAD-I.
In December 2019, we announced initial results from the first pediatric patienttreated with RP-L201, demonstrating early evidence of safety. Analyses ofperipheral vector copy number ("VCN"), and CD18-expressing neutrophils wereperformed through three months after infusion of RP-L201 to evaluate engraftmentand phenotypic correction. The patient exhibited early signs of engraftment withVCN myeloid levels at 1.5 at three months and CD-18 expression of 45%. No safetyor tolerability issues related to RP-L201 administration (or investigationalproduct) had been identified as of that date. The study is expected to enrollnine patients globally.
Pyruvate Kinase Deficiency (PKD):
Red blood cell PKD is a rare autosomal recessive disorder resulting frommutations in the pyruvate kinase L/R ("PKLR") gene encoding for a component ofthe red blood cell ("RBC") glycolytic pathway. PKD is characterized by chronicnon-spherocytic hemolytic anemia, a disorder in which RBCs do not assume anormal spherical shape and are broken down, leading to decreased ability tocarry oxygen to cells, with anemia severity that can range from mild(asymptomatic) to severe forms that may result in childhood mortality or arequirement for frequent, lifelong RBC transfusions. The pediatric population isthe most commonly and severely affected subgroup of patients with PKD, and PKDoften results in splenomegaly (abnormal enlargement of the spleen), jaundice andchronic iron overload which is likely the result of both chronic hemolysis andthe RBC transfusions used to treat the disease. The variability in anemiaseverity is believed to arise in part from the large number of diverse mutationsthat may affect the PKLR gene. Estimates of disease incidence have rangedbetween 3.2 and 51 cases per million in the white U.S. and EU population.Industry estimates suggest at least 2,500 cases in the U.S. and EU have alreadybeen diagnosed despite the lack of FDA-approved molecularly targeted therapies.Enrollment is currently ongoing and we anticipate treating the first patient inthe third quarter of 2020.
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Table of ContentsWe currently have one LVV-based program targeting PKD, RP-L301. RP-L301 is aclinical stage program that we in-licensed from CIEMAT. The IND for RP-L301 toinitiate a global Phase 1 study was cleared by the FDA in October 2019. Thisprogram has been granted EMA orphan drug disease designation and FDA orphan drugdisease designation ("ODD").
This global Phase 1 open-label, single-arm, clinical trial is expected to enrollsix adult and pediatric transfusion-dependent PKD patients in the U.S. andEurope. Lucile Packard Children's Hospital Stanford will serve as the lead sitein the U.S. for adult and pediatric patients, and Hospital InfantilUniversitario Nio Jess will serve as the lead site in Europe for pediatricsand Hospital Universitario Fundacin Jimnez Daz will serve as the lead site inEurope for adult patients.
Infantile Malignant Osteopetrosis (IMO):
IMO is a genetic disorder characterized by increased bone density and bone masssecondary to impaired bone resorption. Normally, small areas of bone areconstantly being broken down by special cells called osteoclasts, then madeagain by cells called osteoblasts. In IMO, the cells that break down bone(osteoclasts) do not work properly, which leads to the bones becoming thickerand not as healthy. Untreated IMO patients may suffer from a compression of thebone-marrow space, which results in bone marrow failure, anemia and increasedinfection risk due to the lack of production of white blood cells. Untreated IMOpatients may also suffer from a compression of cranial nerves, which transmitsignals between vital organs and the brain, resulting in blindness, hearing lossand other neurologic deficits.
We currently have one LVV-based program targeting IMO, RP-L401. RP-L401 is apreclinical program that we in-licensed from Lund University, Sweden. Thisprogram has been granted ODD and Rare Pediatric Disease designation from theFDA. The FDA defines a "rare pediatric disease" as a serious andlife-threatening disease that affects less than 200,000 people in the U.S. thatare aged between birth to 18 years. The Rare Pediatric Disease designationprogram allows for a sponsor who receives an approval for a product topotentially qualify for a voucher that can be redeemed to receive a priorityreview of a subsequent marketing application for a different product. We havepartnered with UCLA to lead U.S. clinical development efforts for the IMOprogram and anticipate that UCLA will serve as the lead U.S. clinical site forIMO. We intend to file an IND for IMO and commence our clinical trial in thefourth quarter of 2020.
Danon disease is a multi-organ lysosomal-associated disorder leading to earlydeath due to heart failure. Danon disease is caused by mutations in the geneencoding lysosome-associated membrane protein 2 ("LAMP-2"), a mediator ofautophagy. This mutation results in the accumulation of autophagic vacuoles,predominantly in cardiac and skeletal muscle. Male patients often require hearttransplantation and typically die in their teens or twenties from progressiveheart failure. Along with severe cardiomyopathy, other Danon disease symptomscan include skeletal muscle weakness, liver disease, and intellectualimpairment. There are no specific therapies available for the treatment of Danondisease. RP-A501 is in clinical trials as an in vivo therapy for Danon disease,which is estimated to have a prevalence of 15,000 to 30,000 patients in the U.S.and the EU, however new market research is being performed and the prevalence ofpatients may be updated in the future.
In January 2019, we announced the clearance of our IND application by the FDAfor RP-A501, and in February 2019, we were notified by the FDA that we weregranted Fast Track designation for RP-A501. University of California San DiegoHealth is the initial and lead center for our Phase 1 clinical trial.
On May 2, 2019, we presented additional preclinical data at the ASCGT annualmeeting, indicating that high VCN, in Danon disease-relevant organs in both miceand non-human primates ("NHN's"), with high concentrations in heart and livertissue (for NHP, cardiac VCN was approximately 10 times higher on average thanin skeletal muscle and central nervous system), which is consistent withreported results in several studies of heart tissue across different species.There were no treatment-related adverse events or safety issues up to thehighest dose. We have dosed three patients in the RP-A501 phase 1 clinicaltrial. We will continue further enrollment with clinical data read-outs in thefourth quarter of 2020.
As of March 2020, we have dosed three patients in the RP-A501 phase 1 clinicaltrial. This completes the first low dose cohort of the Phase 1 study. Based onthe preliminary safety and efficacy data review of this completed cohort, boththe FDA and IDMC has provided clearance to advance to a higher dose cohort inPhase 1 Trial of RP-A501 for Danon Disease. We will continue further enrollmentwith clinical data read-outs in the second half of 2020.
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In addition to its LVV and AAV programs, we also have a program evaluatingCRISPR/Cas9-based gene editing for FA. This program is currently in thediscovery phase. CRISPR/Cas9-based gene editing is a different method ofcorrecting the defective genes in a patient, where the editing is very specificand targeted to a particular gene sequence. "CRISPR/Cas9" stands for Clustered,Regularly Interspaced Short Palindromic Repeats ("CRISPR") Associated protein-9.The CRISPR/Cas9 technology can be used to make "cuts" in DNA at specific sitesof targeted genes, making it potentially more precise in delivering genetherapies than traditional vector-based delivery approaches. CRISPR/Cas9 canalso be adapted to regulate the activity of an existing gene without modifyingthe actual DNA sequence, which is referred to as gene regulation.
Strategy
We seek to bring hope and relief to patients with devastating, undertreated,rare pediatric diseases through the development and commercialization ofpotentially curative first-in-class gene therapies. To achieve these objectives,we intend to develop into a fully-integrated biotechnology company. In the near-and medium-term, we intend to develop our first-in-class product candidates,which are targeting devastating diseases with substantial unmet need, developproprietary in-house analytics and manufacturing capabilities and continue tocommence registration trials for our currently planned programs. In the mediumand long-term, we expect to submit our first biologics license applications("BLAs"), and establish our gene therapy platform and expand our pipeline totarget additional indications that we believe to be potentially compatible withour gene therapy technologies. In addition, during that time, we believe thatour currently planned programs will become eligible for priority review vouchersfrom the FDA that provide for expedited review. We have assembled a leadershipand research team with expertise in cell and gene therapy, rare disease drugdevelopment and commercialization.
We believe that our competitive advantage lies in our disease-based selectionapproach, a rigorous process with defined criteria to identify target diseases.We believe that this approach to asset development differentiates us as a genetherapy company and potentially provides us with a first-mover advantage.
Financial Overview
Since our inception, we have devoted substantially all of our resources toorganizing and staffing the Company, business planning, raising capital,acquiring or discovering product candidates and securing related intellectualproperty rights, conducting discovery, research and development activities forthe programs and planning for potential commercialization. We do not have anyproducts approved for sale and have not generated revenue from product sales.From inception through March 31, 2020, we raised net cash proceeds ofapproximately $373.1 million from investors through both equity and convertibledebt financing to fund operating activities. As of March 31, 2020, we had cash,cash equivalents and investments of $275.9 million.
Since inception, we have incurred significant operating losses. Our ability togenerate product revenue sufficient to achieve profitability will depend heavilyon the successful development and eventual commercialization of one or more ofthe current or future product candidates and programs. We had net losses of$24.7 million for the three months ended March 31, 2020 and $77.3 million forthe year ended December 31, 2019. As of March 31, 2020, we had an accumulateddeficit of $207.8 million. We expect to continue to incur significant expensesand higher operating losses for the foreseeable future as we advance our currentproduct candidates from discovery through preclinical development and clinicaltrials and seek regulatory approval of our product candidates. In addition, ifwe obtain marketing approval for any of their product candidates, we expect toincur significant commercialization expenses related to product manufacturing,marketing, sales and distribution. Furthermore, we expect to incur additionalcosts as a public company. Accordingly, we will need additional financing tosupport continuing operations and potential acquisitions of licensing or otherrights for product candidates.
Until such a time as we can generate significant revenue from product sales, ifever, we will seek to fund our operations through public or private equity ordebt financings or other sources, which may include collaborations with thirdparties and government programs or grants. Adequate additional financing may notbe available to us on acceptable terms, or at all. We can make no assurancesthat we will be able to raise the cash needed to fund our operations and, if wefail to raise capital when needed, we may have to significantly delay, scaleback or discontinue the development and commercialization of one or more productcandidates or delay pursuit of potential in-licenses or acquisitions.
Because of the numerous risks and uncertainties associated with productdevelopment, we are unable to predict the timing or amount of increased expensesor when or if we will be able to achieve or maintain profitability. Even if weare able to generate product sales, we may not become profitable. If we fail tobecome profitable or are unable to sustain profitability on a continuing basis,then we may be unable to continue our operations at planned levels and be forcedto reduce or terminate our operations.
Revenue
To date, we have not generated any revenue from any sources, including fromproduct sales, and we do not expect to generate any revenue from the sale ofproducts in the near future. If our development efforts for product candidatesare successful and result in regulatory approval or license agreements withthird parties, we may generate revenue in the future from product sales.
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Research and Development Expenses
Our research and development program ("R&D") expenses consist primarily ofexternal costs incurred for the development of our product candidates. Theseexpenses include:
expenses incurred under agreements with research institutions that conduct
research and development activities including, process development,
preclinical, and clinical activities on Rocket's behalf;
costs related to process development, production of preclinical and clinical
materials, including fees paid to contract manufacturers and manufacturing
input costs for use in internal manufacturing processes;
consultants supporting process development and regulatory activities; and
costs related to in-licensing of rights to develop and commercialize our
product candidate portfolio.
We recognize external development costs based on contractual payment schedulesaligned with program activities, invoices for work incurred, and milestoneswhich correspond with costs incurred by the third parties. Nonrefundable advancepayments for goods or services to be received in the future for use in researchand development activities are recorded as prepaid expenses.
Our direct research and development expenses are tracked on a program-by-programbasis for product candidates and consist primarily of external costs, such asresearch collaborations and third party manufacturing agreements associated withour preclinical research, process development, manufacturing, and clinicaldevelopment activities. Our direct research and development expenses by programalso include fees incurred under license agreements. Our personnel, non-programand unallocated program expenses include costs associated with activitiesperformed by our internal research and development organization and generallybenefit multiple programs. These costs are not separately allocated by productcandidate and consist primarily of:
Our research and development activities are central to our business model.Product candidates in later stages of clinical development generally have higherdevelopment costs than those in earlier stages of clinical development. As aresult, we expect that research and development expenses will increasesubstantially over the next several years as we increase personnel costs,including stock-based compensation, support ongoing clinical studies, seek toachieve proof-of-concept in one or more product candidates, advance preclinicalprograms to clinical programs, and prepare regulatory filings for productcandidates.
We cannot determine with certainty the duration and costs to complete current orfuture clinical studies of product candidates or if, when, or to what extent wewill generate revenues from the commercialization and sale of any of our productcandidates that obtain regulatory approval. We may never succeed in achievingregulatory approval for any of our product candidates. The duration, costs, andtiming of clinical studies and development of product candidates will depend ona variety of factors, including:
the scope, rate of progress, and expense of ongoing as well as any future
clinical studies and other research and development activities that we
undertake;
future clinical trial results;
uncertainties in clinical trial enrollment rates;
changing standards for regulatory approval; and
the timing and receipt of any regulatory approvals.
We expect research and development expenses to increase for the foreseeablefuture as we continue to invest in research and development activities relatedto developing product candidates, including investments in manufacturing, as ourprograms advance into later stages of development and as we conduct additionalclinical trials. The process of conducting the necessary clinical research toobtain regulatory approval is costly and time-consuming, and the successfuldevelopment of product candidates is highly uncertain. As a result, we areunable to determine the duration and completion costs of research anddevelopment projects or when and to what extent we will generate revenue fromthe commercialization and sale of any of our product candidates.
Our future research and development expenses will depend on the clinical successof our product candidates, as well as ongoing assessments of the commercialpotential of such product candidates. In addition, we cannot forecast with anydegree of certainty which product candidates may be subject to futurecollaborations, when such arrangements will be secured, if at all, and to whatdegree such arrangements would affect our development plans and capitalrequirements. We expect our research and development expenses to increase infuture periods for the foreseeable future as we seek to complete development ofour product candidates.
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ROCKET PHARMACEUTICALS : Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) - marketscreener.com
Researchers Convert Astrocytes to Neurons In Vivo to Treat… : Neurology Today – LWW Journals
Article In Brief
A mouse study shows that select transcription factors to the striatum can effectively and safely convert astrocytes to neurons to treat Huntington's disease.
Delivering two transcription factors to the striatum in a mouse model of Huntington's disease can safely convert astrocytes into neurons with high efficiency, according to a new study in the February 27 issue of Nature Communications.
The neurons grow to and wire up with their targets in the globus pallidus and substantia nigra, and remaining astrocytes proliferate to replace those that have been converted. The treatment extends the lifespan and improves the motor behavior of the mice.
What is exciting about this study is that the authors have clearly made cells that do what they are supposed to do, namely replace dying neurons in existing circuits, said Roger Barker, PhD, professor of clinical neuroscience and honorary consultant in neurology at the University of Cambridge and at Addenbrooke's Hospital, who was not involved in the work. I think the challenge of scaling up this strategy to the human Huntington's disease brain is pretty substantial, but nonetheless, this is an important discovery.
The new study, led by Gong Chen, PhD, builds on discoveries beginning in the mid-2000s showing that a small number of exogenously applied transcription factors could transform skin fibroblasts into stem cells, which could then be further converted to become virtually any cell type. That discovery was quickly followed by advances in direct reprogramming, in which one cell type is directly converted into another, skipping the stem cell intermediate.
Most of that work has taken place in vitro, and most attempts to use the strategy therapeutically have depended on transplantation of stem cells or newly converted cells.
We tried stem cell transplants to the mouse brain 10 years ago, but we couldn't find a lot of functional neurons, said Dr. Chen, professor at Guangdong-Hong Kong-Macau Institute of CNS Regeneration of Jinan University in Guangzhou, China.
It was also clear that anything you do in vitro, you eventually have to transplant, and that didn't seem to be a very promising technology, so I said, Let's try this in vivo, and put transcriptions factors directly into the mouse brain.
Dr. Chen initially tried introducing the transcription factor neurogenin 2, but the efficiency of conversion of astrocytes to neurons was very low, so he turned to the transcription factor NeuroD1, which Dr. Chen's group had previously shown could convert astrocytes into excitatory glutamatergic neurons.
In the current study, in order to generate GABAergic neurons, the team combined NeuroD1 with another transcription factor, D1x2, based on previous work showing its importance for generating GABAergic neurons.
The team packed the genes for the transcription factors into a recombinant adeno-associated virus vector (rAAV 2/5) and used an astrocyte-specific promoter to drive the transgene expression so that it preferentially expresses in astrocytes. They first injected the vector into the normal mouse striatum.
Surprisingly, this strategy worked very well at high efficiency, Dr. Chen said. After seven days, all transfected cells expressed astrocyte markers, indicating a high level of specificity in the vector. Of those cells, 81 percent co-expressed the two transcription factors. By 30 days, 73 percent of the cells expressing the transcription factors now expressed neuronal, rather than astrocytic markers, and were primarily GABAergic in character.
Next, Dr. Chen asked whether the remaining astrocytes could repopulate to replace those lost to conversion. Using immunostaining for astrocytes and neurons, as well as other techniques, the team found that the neuron/astrocyte ratio was unchanged, and that some remaining astrocytes could be found at different stages of cell division, suggesting the process facilitated astrocyte proliferation.
Dr. Chen then turned to the R6/2 mouse, the most common mouse model of Huntington's disease. He treated mice at 2 months of age, just as they began to show motor symptoms
As in the wild-type mice, astrocytes were converted to GABAergic neurons at high efficiency without altering the neuron/astrocyte ratio. The researchers observed similar results in a less-severe HD mouse model as well. Treated mice had only about half the degree of striatal atrophy as untreated mice. The converted neurons still contained aggregated huntingtin protein, but less than in native neurons, and similar to the reduced amount found in astrocytes in the mouse brain.
The real test of any cell therapy in neurodegenerative disease is whether the new cells can link into the existing circuits and provide functional benefit, feats that have been hard to achieve with transplanted fetal cells or stem cells.
Examining striatal slices from the treated mice, Dr. Chen found that the converted neurons displayed electrical properties largely identical to those of normal neurons, including resting potential, action potential threshold, firing amplitude, and firing frequency. They integrated into local circuits and behaved similarly to the native neurons around them. By tracking a marker contained in the AAV gene construct, they showed that converted neurons projected axons to the two basal ganglia targets of medium spiny neurons in the striatum, the globus pallidus and the substantia nigra.
Finally, Dr. Chen found that stride length and travel distance were both significantly improved in treated mice, though still falling below those of wild-type mice, and lifespan was significantly extended.
There were no hints of tumors in the mice, Dr. Chen noted. He suggested that in situ conversion is likely intrinsically safer in this regard than using stem cell-derived neurons, since a proliferative astrocyte is being converted into a non-proliferative neuron, with no residual pool of unconverted and potentially tumorigenic stem cells. We are actually reducing the tumor risk, he said.
Why the converted neurons developed appropriate neuronal connections is an important unanswered question, Dr. Chen said. He suggested there were two important factorsfirst, the astrocytes from which they arose are likely developmentally related to neighboring neurons, and thus may express similar position markers that help guide them to the right targets, just like the native neurons. Second, those remaining neurons may also provide guide tracks for the newly growing axons.
This conversion technique is not limited to Huntington's disease, he stressed, noting that his team last year published a paper showing promise in ischemic stroke, and work is underway to test its potential in Alzheimer's disease, Parkinson's disease, spinal cord injury, and ALS. He is also moving on to testing in non-human primates, setting the stage for eventual human trials.
I think eventually we will want to correct the Huntington's mutation as well, Dr. Chen said, for instance by using CRISPR, but he pointed out that while that strategy can repair diseased neurons, it cannot make new ones, like astrocyte-to-neuron conversion can.
This study is really elegantly done, commented Veronica Garcia, PhD, who has studied astrocytes derived from induced pluripotent stem cells from Huntington's disease patients as a postdoctoral scientist working with Clive Svendsen, PhD, in the Regenerative Medicine Institute at Cedars-Sinai Medical Center in Los Angeles.
The conversion efficiency is similar between wild-type and disease models, suggesting that the disease process is not interfering with the conversion, she said.
Astrocyte depletion does not seem to be a problem, at least in the short term, but Dr. Garcia noted there is a limit on the number of divisions astrocytes appear able to undergo, after which they lose the ability to proliferate. That may be a problem for chronic treatment, she suggested. Nonetheless, these results really look promising for therapeutic development.
The concept of trying to reprogram cells in situ to take on the phenotype of the cells that are lost is not new, commented Dr. Barker, but being able to do it with any degree of efficiency, to make enough cells to make a significant difference, has been problematic. For that reason, and because the cells grow to their target sites and make connections, these results are surprising.
A major hurdle for clinical trials, he noted, will be scaling up to the human striatum, which has approximately 100 times the volume of that in the mouse. Delivering the vector to such a large volume will be a significant challenge, he said, along with determining whether this approach will really work in a disease that affects many different brain structures such as in HD.
Dr. Chen is co-founder of NeuExcell Therapeutics Inc, which will develop clinical trials in the future. Drs. Barker and Garcia disclosed no conflicts.
Original post:
Researchers Convert Astrocytes to Neurons In Vivo to Treat... : Neurology Today - LWW Journals
Best Skin-Care Routine: Order of Products to Use Morning & Night – Glamour
The best cleanser for you will depend on your skin type. "It's important to pay attention to what's in your cleanser and what's not in it," says Ciraldo. She recommends avoiding sulfates, which can have a harsh, stripping effect on your face, and looking for actives that suit your needs. "For normal or dry skin, I favor a hydrating cleanser with peptides," she says. "If you're oily or acne-prone, use a mild exfoliating cleanser with salicylic acid, which dislodges the dead cells that can clog pores."
Do this step: Morning and night.
The first product to go on your face? Eye cream. The reason is simplebecause you'll probably forget to do it otherwise. Ciraldo recommends patting eye cream on gently with your ring finger (this way you'll tug less at the delicate skin there) all the way around your eyes, not just underneath them. If you're worried about eye cream causing your concealer or eye makeup to smear, choose a more lightweight option, like a hydrating gel that sinks in quickly and stays put.
For the best results, look for ingredients like peptideswhich help tighten your skin and depuffas well as antioxidants. Rabach recommends formulas that contain hydrating hyaluronic acid, brightening caffeine, and ceramides (these lock in moisture and help strengthen your skin barrier).
Do this step: Morning and night.
Both toners and essences are meant to help further prime your skin to absorb active ingredients, but the one you choose will depend on your skin type. Old-school toners were meant to balance skin pH and counteract alkaline soaps, before soap-free cleansers became popular. Now toner usually refers to liquid formulations geared toward oily skin that's in need of gentle exfoliation and resurfacing. Ciraldo says those with oily or acne-prone skin should look for toners with ingredients like glycolic or salicylic acid.
Essences, on the other hand, tend to be more hydrating. Rabach recommends looking for actives like hyaluronic acid, which will flood your skin with moisture that you can lock in during subsequent steps. To apply, soak a cotton pad in liquid and gently pat it over your face. Alternatively, you can use your hands to do the same thing.
Do this step: Morning and night.
This is the step where you'll deliver the bulk of active ingredients to your toner/essence-primed face, and it's important to do it early on in your routine. "Serums are formulated with smaller molecular-weight actives so they penetrate into deeper skin layers," says Ciraldo. "If you apply your serum after a thicker formulation, the active ingredients may not penetrate as well."
While you should apply serum twice a day, you shouldn't be using the same formulation. "Serum actives differ for day and night," says Rabach. During the day, she likes to choose serums with antioxidants that protect skin from daytime stressors like free radicals (caused by UV rays), pollutants, and blue light. The most popular ingredient for this is vitamin C, which you will have no problem finding in serum form. (Just make sure to choose one that's properly stabilized for maximum effect.) At night, opt for a serum with peptides and growth factors to repair skin.
For both daytime and nighttime serums, Rabach also has a general list of ingredients she likes to look for across both formulations: Niacinamide to reduce redness, hyaluronic acid to pull moisture into your skin, and alpha and beta hydroxy acids (AHAs and BHAs), which help boost collagen and even out skin pigmentation. Ciraldo further splits up her preferred serum ingredients by skin type. "For acne-prone skin, look for stem cells, retinol, and green tea," she says. "For dehydrated skin, look for lipids, hyaluronic acid, and peptides. And for hyperpigmented skin, look for vitamin C."
Do this step: At night only.
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Best Skin-Care Routine: Order of Products to Use Morning & Night - Glamour
World Thalassemia Day 2020: Causes, Symptoms, Diagnosis And Treatment of The Disease – India.com
World Thalassemia Day is an annual observance day that occurs on May 8th. It is a world-wide campaign to raise awareness about thalassemia and its symptoms. This is done to help the patients living with this genetic disorder. World Thalassemia Day commemorates thalassemia victims and also aims at making thalassemia patients aware about the significance of medical consultation before marriage. This global observance day also tries to debunk myths and misconceptions surrounding the disease. The theme of World Thalassemia Day 2020 is Begin thalassemia prevention from young age, blood test before marriage will make the future generation safe. On this day, here we tell you all about the disease. Also Read - World Thalassemia Day 2019: How to Deal With Thalassemia
It is a genetic blood disorder that significantly reduces your haemoglobin count. Notably, haemoglobin is a protein molecule present in red blood cells. This protein helps RBCs in carrying oxygen and circulating it in the entire body. Also Read - World Thalassemia Day: Risk Factors, Types And Prevention Tips
The signs and symptoms of thalassemia depend on the type of thalassemia you have and its severity. Some common symptoms include fatigue, slow growth, weakness, abdominal swelling, pale skin, dark urine facial bone deformities etc. Usually, either a newborn shows thalassemia symptoms at the time of birth itself or develops it in the first two years of life. Also Read - World Thalassemia Day 2017: Importance of Blood donation and how it helps people with this fatal disease
Thalassemia occurs when the DNA of your body cells responsible for making haemoglobin, undergo mutation. This mutated DNA is passed on to the next generation.
A simple blood test can confirm the disease. Usually, if an expecting mother is known to be suffering from thalassemia, doctors perform a certain tests to find out if the fetus has also inherited the diseases and if yes, what is the severity of the genetic disease. To do that, chorionic villus sampling (testing a tiny sample of placenta) and amniocentesis (examining sample of fluid surrounding foetus) are performed.
In case, you have inherited a minimum number of mutated genes and suffering from mild thalassemia, you do not require treatment. However, in severe case, you may have to go through frequent blood transfusion, chelation therapy, or stem cell transplant.
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World Thalassemia Day 2020: Causes, Symptoms, Diagnosis And Treatment of The Disease - India.com
FDA Approves Tabrecta, the First Targeted Drug for Patients with Non-Small Cell Lung Cancer and MET exon 14 – Curetoday.com
Tabrecta (capmatinib) will treat patients with metastatic non-small cell lung cancer that has a mutation leading to MET exon 14 skipping. The drug is the first targeted option for patients with lung cancer and this type of mutation.
Tabrecta is the first therapy approved by the FDA specifically to treat NSCLC with mutations that lead to epithelial-mesenchymal transition (EMT), which is MET exon 14 skipping.
Tabrecta is approved for patients who are new to treatment and also those who have received previous therapies, regardless of prior treatment type.
Along with the drug approval, the FDA gave the green light to a companion diagnostic, the FoundationOne CDx assay, which can identify these mutations in patients.
In epithelialmesenchymal transition(EMT), the cells that line an organ lose their polarity and ability to adhere to other cells, giving them the ability to invade tissues and organs. MET exon 14 skipping means that a segment of RNA that should prompt the production of a specific protein stops sending those messages.
The spread of cancer consists of a sequential series of events and MET exon 14 skipping is recognized as a critical event in this process, the FDA stated in a press release about the approval. Mutations leading to MET exon 14 skipping are found in 3% to 4% of patients with lung cancer, the agency stated.
Lung cancer is increasingly being divided into multiple subsets of molecularly defined populations with drugs being developed to target these specific groups, said Dr. Richard Pazdur, director of the FDAs Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDAs Center for Drug Evaluation and Research, in the release.
Taken orally, Tabrecta works by blocking a key protein that drives metastatic NSCLC in these patients. The FDA approved it based on the results of a clinical trial involving patients with NSCLC who had mutations leading to MET exon 14 skipping; their tumors did not express the proteins EGFR or ALK.
The evaluated study population included 28 patients who had never undergone treatment for NSCLC and 69 previously treated patients. The overall response rate (ORR; the percentage of participants who experienced a prespecified amount of tumor shrinkage) for the 28 participants was 68%, with 4% having a complete response and 64% having a partial response.
The ORR for the 69 participants was 41%, with all having a partial response. Of the responding participants who had never undergone treatment for NSCLC, 47% had a duration of response lasting 12 months or longer compared with 32.1% of the responding participants who had been previously treated.
Common side effects for patients taking Tabrecta included swelling of the legs, nausea, fatigue, vomiting, shortness of breath and decreased appetite.
Tabrecta may cause serious side effects including scarring or inflammation of the lungs. It may also cause damage to liver cells or harm a developing fetus or newborn baby. Patients may be more sensitive to sunlight when they take Tabrecta and should take precautions to cover their skin and use sunscreen.
Tabrecta was approved under theFDAs accelerated approval, breakthrough designation and priority review programs, which provide for a quicker review of drugs that treat serious or life-threatening diseases and represent a meaningful advantage over existing treatments.
Continued approval for this indication may be contingent upon verification of these results in confirmatory clinical trials.
Check back for what you need to know regarding this approval.
Originally posted here:
FDA Approves Tabrecta, the First Targeted Drug for Patients with Non-Small Cell Lung Cancer and MET exon 14 - Curetoday.com
Merck to Present New Data from its Broad Oncology Portfolio and Pipeline at the ASCO20 Virtual Scientific Program – Business Wire
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from its oncology program will be presented at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program from May 29-31. More than 80 abstracts in nearly 20 types of solid tumors and blood cancers have been accepted across Mercks broad cancer portfolio and investigational pipeline, including KEYTRUDA, Mercks anti-PD-1 therapy; LENVIMA (in collaboration with Eisai); LYNPARZA (in collaboration with AstraZeneca); and MK-6482 (formerly PT2977), an investigational, oral hypoxia-inducible factor-2 alpha (HIF-2) inhibitor.
Despite the challenges we all face due to the COVID-19 pandemic, Merck remains fully committed to supporting the cancer community and to advancing important scientific research from our clinical program, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. The data to be presented at this years ASCO demonstrate how our deep and diverse oncology portfolio continues to show meaningful outcomes for patients in new tumor types and stages of disease, while long-term survival data for KEYTRUDA in non-small cell lung cancer, renal cell carcinoma and melanoma further support its important role in these types of cancer.
Key abstracts including late-breakers, oral sessions, and select poster discussions and posters to be presented at ASCO include:
Merck Investor Event
Merck will hold a virtual investor event in conjunction with the ASCO20 Virtual Scientific Program on Tuesday, June 2 at 2 p.m. ET. Details will be provided at a date closer to the event at http://investors.merck.com/home/default.aspx.
Details on Abstracts Listed Above, Additional Presentations and Key Abstracts with Mercks Collaboration Partners
KEYTRUDA
Breast Cancer
Bladder Cancer
Classical Hodgkin Lymphoma
Colorectal Cancer
Lung Cancer
Renal Cell Carcinoma
Prostate Cancer
Melanoma
Ovarian Cancer
Head and Neck Cancer
KEYTRUDA plus LENVIMA (in collaboration with Eisai)
Hepatocellular Carcinoma
Renal Cell Carcinoma
Endometrial Cancer
LYNPARZA (in collaboration with AstraZeneca)
Ovarian Cancer
MK-6482
Renal Cell Carcinoma
About KEYTRUDA (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA (pembrolizumab) Indications
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Small Cell Lung Cancer
KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High (MSI-H) Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Endometrial Carcinoma
KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Selected Important Safety Information for KEYTRUDA
Immune-Mediated Pneumonitis
KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.
Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.
Immune-Mediated Colitis
KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.
Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)
Immune-Mediated Hepatitis
KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.
Hepatotoxicity in Combination With Axitinib
KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.
Immune-Mediated Endocrinopathies
KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.
Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.
Immune-Mediated Nephritis and Renal Dysfunction
KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.
Immune-Mediated Skin Reactions
Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.
Other Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.
The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.
Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.
Infusion-Related Reactions
KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.
In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.
Increased Mortality in Patients With Multiple Myeloma
In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.
Embryofetal Toxicity
Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.
Adverse Reactions
Stem Cells Market 2020 Size, Global Trends, Comprehensive Research Study, Development Status, Opportunities, Future Plans, Competitive Landscape and…
Global Stem Cells Market 2020 Global Industry report covers the latest market statistics, industry growth driving factors, size, share, trends, as well as Forecast till 2026. The Global Industrial Stem Cells market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.
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Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. Commonly, stem cells come from two main sources: Embryos formed during the blastocyst phase of embryological development (embryonic stem cells) and Adult tissue (adult stem cells).Both types are generally characterized by their potency, or potential to differentiate into different cell types (such as skin, muscle, bone, etc.).Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost 100 countries around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Stem Cells market in 2020.COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.
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COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets. The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.
Global Stem Cells market competition by top manufacturers, with production, price, revenue (value) and market share for each manufacturer; the TOP PLAYERS including;
For the data information by region, company, type, and application, 2020 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.
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The Stem Cells Market report examines competitive scenario by analyzing key players in the market. The company profiling of leading market players is included in this report with Porters five forces analysis and Value Chain analysis. Further, the strategies exercised by the companies for expansion of business through mergers, acquisitions, and other business development measures are discussed in the report. The financial parameters which are assessed include the sales, profits and the overall revenue generated by the key players of Market.
Stem Cells Breakdown Data by Type:
Stem Cells Breakdown Data by Application:
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Stem Cells Market by Regions:
Key questions answered in the report:
Highlights of the report which will influence the Stem Cells market:
Major Points from Table of Contents:
1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered1.4 Market Analysis by Type1.4.1 Global Stem Cells Market Size Growth Rate by Type (2015-2026)1.4.2 Major-Type1.4.3 Independent-Type1.4.4 Administrator-Type1.5 Market by Application1.5.1 Global Stem Cells Market Share by Application (2015-2026)1.5.2 Commercial1.5.3 Commonweal1.5.4 Other1.6 Study Objectives1.7 Years Considered
2 Global Growth Trends2.1 Stem Cells Market Size2.2 Stem Cells Growth Trends by Regions2.2.1 Stem Cells Market Size by Regions (2015-2026)2.2.2 Stem Cells Market Share by Regions (2015-2020)2.3 Industry Trends2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Opportunities
3 Market Share by Key Players3.1 Stem Cells Market Size by Manufacturers3.1.1 Global Stem Cells Revenue by Manufacturers (2015-2020)3.1.2 Global Stem Cells Revenue Market Share by Manufacturers (2015-2020)3.1.3 Global Stem Cells Market Concentration Ratio (CR5 and HHI)3.2 Stem Cells Key Players Head office and Area Served3.3 Key Players Stem Cells Product/Solution/Service3.4 Date of Enter into Stem Cells Market3.5 Mergers & Acquisitions, Expansion Plans
4 Breakdown Data by Type and Application4.1 Global Stem Cells Market Size by Type (2015-2020)4.2 Global Stem Cells Market Size by Application (2015-2020)
(5, 6, 7, 8, 9, 10, 11) United States, Europe, China, Japan, Southeast Asia, India, Central & South AmericaStem Cells Market Size (2015-2020)Key PlayersStem Cells Market Size by TypeStem Cells Market Size by Application
12 International Players ProfilesCompany DetailsCompany Description and Business OverviewStem Cells IntroductionRevenue in Stem Cells Business (2015-2020)Recent Development
13 Market Forecast 2020-202613.1 Market Size Forecast by Regions13.2 United States13.3 Europe13.4 China13.5 Japan13.6 Southeast Asia13.7 India13.8 Central & South America13.9 Market Size Forecast by Product (2020-2026)13.10 Market Size Forecast by Application (2020-2026)
14 Analysts Viewpoints/Conclusions
15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.1.1 Research Programs/Design15.1.1.2 Market Size Estimation12.1.1.3 Market Breakdown and Data Triangulation15.1.2 Data Source15.1.2.1 Secondary Sources15.1.2.2 Primary Sources15.2 Disclaimer15.3 Author Details
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FTSE 100 closes up and nearing 6,000 as investor optimism continues – Proactive Investors UK
Britain's index of top shares closed on Thursday over 82 points ahead, or 1.4%, at 5,935
FTSE 100 index closed higher on Thursday on investor optimism ahead of the VE Day bank holiday as US benchmarks also surged
Britain's index of top shares closed over 82 points ahead, or 1.4%, at 5,935.
"Lately there has been a lot of optimism that governments are keen to loosen their lockdown restrictions, so that has fuelled the bullish move in equities," said David Madden, analyst at CMC Markets.
"Dealers have the impression that we are over the worst of it in terms of the lockdowns, so that should the pave the way less stringent restrictions."
Crude prices are also heading north as Saudi Arabia has lifted selling prices for oil, while US producers have curtailed output. In addition, US gas stockpiles have been falling.
Brent crude gained 4.61% to US$31.09 a barrel, while WTI added 8.30% to US$25.98.
On Wall Street, the Dow Jones added over 401 points at 24,066, while the S&P 500 gained over 50 points and the Nasdaq surged 140 points.
US indices, as expected, flashed out of the traps on Thursday.
The Dow Jones average was up 283 points (1.2%) at 23,948 and the S&P 500 rose 35 points (1.2%) at 2,884, despite the weekly first-time jobless claims number coming in a bit higher than expected.
US initial jobless claims declined to 3.2mln during the week ending May 2 from 3.8mln in the prior week (consensus: 3.0mln), bringing the total over the last seven weeks to 33.5mln, observed Mickey levy at Berenberg Capital Markets.
Based on the 26m total initial jobless claims between March 15 and April 18, we expect the Bureau of Labor Statistics (BLS) to report that U.S. non-farm payrolls declined by 21m in April and that the unemployment rate increased to 16.2% from 4.4% in its Official Monthly Employment Report, scheduled for release tomorrow,2 he added.
In London, the FTSE 100 was up 75 points (1.3%) at 5,930, with little sign of traders closing out positions ahead of the long weekend.
Oil stocks are doing their bit to bolster the index as the price of Brent crude heads US$1.05 higher (3.6%) to US30.78 a barrel; oil prices are firming up despite Saudi Arabia reducing its official selling prices to Asian customers.
Saudi Arabia today (07 May) reduced its official selling prices (OSPs) to Asia in June 2020 and crude oil prices are bouncing 6-9% on the back of that news. It signals that Saudi Arabia sees the June 2020 crude oil market as less of a crowded place and that it will be easier for the producer to place its desired volumes into the market. In a slight parallel to this, we think that it is unlikely to be a wall of surplus oil banging on the door of Cushing Oklahoma in June 2020 comparable to the magnitude of the May 2020 contract, said Bjarne Schieldrop, the chief commodities analyst at SEB, the Nordic investment bank.
The market is concerned that we might get the same kind of end-of-contract disturbances for the June 2020 contract as we got for the May 2020 contract. If so, it is highly unlikely that we would see -$40/bl again since the market now is prepared. It is still possible that the WTI June 2020 contract could come under intense selling pressure over the coming nine trading days as long positions move to exit. The special thing about the WTI contract is of course that it is based and priced inland in Cushing Oklahoma in the US. It is land-locked with flows in and out of the storage hub going by pipelines. If inventories in Cushing are full and pipes out of Cushing are full then prices can crash, he explained.
() was 0.7% higher at 315.8p while PLC () advanced 2.7% to 1,264p.
US indices are tipped to open on the front foot this afternoon despite some slightly iffy jobs numbers.
The Dow Jones average is seen opening its account at around 23,915, up 250 points from last nights close and the S&P 500 is tipped to toddle 35 points higher to 2,883.
First-time weekly jobless claims last week fell to 3.16mln from 3.85mln the week before but were above the consensus forecast of 3mln.
The consensus looked a bit optimistic in light of hard data from Pennsylvania, Wisconsin and Arizona, and Google searches for 'file for unemployment', but the trend is falling, said Ian Shepherdson, the chief economist at Pantheon Macroeconomics.
Claims continue to decay by about 15-to-18% per week and are now at less than half the 6.9mln peak in the week of March 28. If the current rate of decline continues, claims will dip below 1mln in the second ormore likelythird week of June, though they would remain well above the 665K worst single week after the crash of 2008, Shepherdson noted.
In London, the FTSE 100 was up 56 points (1.0%) at 5,910.
As the morning drew to a close, the FTSE 100 moved into gains consolidation mode.
Londons index of leading shares was up 41 points (0.7%) at 5,894.
It has been another bad morning for travel-related stocks, however, with British Airways owner International Consolidated Airlines () sharply lower after its first-quarter results and cruise lines owner () slightly lower after it extended the pause period for some of its brands.
IAG shed 4.3% at 188.3p after it warned the second quarter would be significantly worse than the first quarter. The company is considering making a meaningful return to service in July.
Unfortunately the numbers are going to get worse before they start to smooth out, because the sharp drop off in capacity happened when the quarter had already started; however the same can also be said for a number of the groups cost-saving plans, where were yet to see the benefits in the results. The net effect of these delays is yet to be determined, but one thing we do know is that we will be looking at a very different business on the other side of this storm, said Sophie Lund-Yates, an equity analyst at Hargreaves Lansdown. Carnival was 0.9% lower at 901p after its Princess Cruises cancelled selected cruises through to the end of the summer season.
Meanwhile, its Holland America Line has decided to extend its pause of global cruise operations and cancel all Alaska, Europe and Canada/New England cruises for 2020.
After a mid-morning dip, the Footsie has kicked on again, despite being weighed down by ().
The index of leading shares up 48 points (0.8%) at 5,902, even with telecoms giant 9.1% lower at 103.8p as it bowed to the inevitable with its overly generous dividend.
The decision to cancel the final dividend for the year to March 2020, pay nothing at all in the period to March 2021 and then halve the annual payment to 7.7p a share in fiscal 2022 saves BT some 3.3 billion and leaves income-hungry shareholders merely with the hope that there will be some long-term gain after this considerable short-term pain, said AJ Bells investment director, AJ Bell.
Confirmation that s and Telefonicas O2 are to mergewill not have helped sentiment towards BT, either.
Housebuilders are doing fine, though, despite a predictably downbeat Halifax house price index reading for April.
According to the mortgage lender, house prices fell 0.6% in March but were still 2.7% higher than in April 2019.
The impact of measures taken to curtail the spread of coronavirus started to filter through to the housing market in April, said the Halifaxs managing director, Russell Galley.
With market activity currently almost at a complete standstill, the limited number of transactions available means that calculating average house prices has inevitably become more challenging. This will lead to a great deal of volatility until more data becomes available, he explained.
Lucy Pendleton of estate agent James Pendleton not exactly a disinterested observer chose to put a positive spin on numbers that she conceded were not statistically significant.
If this data is worth anything at all, it actually betrays a story of strength. The annual growth rate remains nearly 3% and this is yet more evidence of how well the market was doing before the pandemic struck, she said.
This fact will play a significant role in what prices look like when the market restarts. A bullish picture going into this crisis actually means we are likely to see healthy prices when we return. There will be a period in which vendors test the water but you can expect them to stand behind valuations they were confident of achieving before the lockdown began, she opined.
Investors seemed to be on board with that analysis, and pushed the shares of PLC (), Holdings PLC (), PLC () and PLC () higher.
All were posting gains that surpassed the index;s advance; Barratt was up 2.9% at 532p; Berkeley was 1.6% higher at 4,265p; was 2.0% heavier at 2,295p; and was also up 2.0%, at 152.65p.
Ahead of the long weekend, Londons blue-chips are firmer on balance after trade data from China was not as terrible as feared.
The FTSE 100 was up 20 points (0.3%) at 5,873.
This mornings latest China trade numbers for April showed little evidence of a recovery in economic activity despite the lifting of lockdown back at the beginning of March, grumbled Michael Hewson at CMC Markets.
Exports were better than expected, rising 3.5%, probably helped by the shipping of medical products like PPE as the rest of the world wrestled with the virus while in various states of lockdown. In worrying signs that internal demand remains weak imports slid much more than expected, falling sharply, by 14.2%, suggesting that while the economy was reopening activity was far from normal, with consumers behaving more cautiously.
The lack of any signs of a significant rebound in China along with yesterdays ghastly ADP employment report which saw over 20mln people lose their jobs in April is slowly bringing it home to markets the terrible economic toll the coronavirus pandemic is set to inflict on the US economy, as well as the global economy more broadly, Hewson opined, although if markets are getting the message, they are not getting it today.
The s policy makers have estimated that the UK economy will be 30% smaller by the end of the economy, which was a bigger fall than most pointy-headed members of the economic forecasting community were predicting.
Despite that, the Bank has opted not to any major policy changes today in the wake of a conflab between its policy makers.
Of course there is plenty of uncertainty about what will happen later this year and beyond, but we suspect the true path of the recovery will be more gradual. We dont expect the economy to recover its lost ground until at least 2022, and perhaps later, said Kalum Pickering at ING.
Pickering thinks an additional round of quantitative easing will arrive eventually and noted that interestingly two committee members voted for a 100bn extension at this meeting.
The FTSE 100 made a positive start on Thursday in the face of a grim update from the , which has warned that UK GDP could contract by 30% in the second quarter.
The index of UK blue-chips rose 30 points higher to 5,883.54. The London market will be closed tomorrow for the VE Day 75th anniversary bank holiday.
Perhaps acrumb of comfort from the update was the Banks prediction of a rapid recovery from its current dire position.
New BoE governor Andrew Bailey reckoned thus far there is only limited scarring to the economy thanks to financial support such as the Treasurys furlough scheme.
The Bank seems to be in the V-shaped recovery camp, said Neil Wilson of Markets.com.
Of course, the fear is the global economy could be driven into a prolonged and hugely damaging U-shaped recession as a result of the coronavirus pandemic.
More monetary support is inevitable after the BoE also opted not to increase its asset purchase scheme and left interest rates on hold, reckons Wilson.
Two things stand out: Firstly, more QE [quantitative easing] is coming, even if its not today, he explained. Two members of the MPC [the Monetary Policy Committee] voted to increase the stock of asset purchases by 100bn at this meeting.
Turning to the market and corporate news, BT () has opted to forego the dividend for the first time in two decades in order to continue investing in its fibre broadband network. While the news was widely reported over the weekend, the stock still came under pressure early on as it slid 5.8%.
Rolls Royce () fell a further 4.4% after a union official was reported as saying the pandemic would be worse for the aero-engines giant than 9/11, adding it would be difficult to save jobs.
() () said it has reached an agreement with XCD Energy Ltds (LON:ASX:XCD) board for a unanimously recommended merger. The prior unsolicited takeover bid had achieved backing of about 18.5% of XCDs shareholders, and the recommended merger comes with improved terms. In the all-paper deal, 88 Energy will issue 2.4 new 88 Energy shares and 0.7 for every listed share option held -up from 1.67 per share and 0.5 per option. XCDs board now recommend that its shareholders accept the offer, in the absence of any superior proposals. They will hold around 20% of the enlarged company as a result of the transaction.
(), the AIM-listed drug discovery company, has announced plans to raise at least 1mln by placing shares at 15p a throw. C4X shares closed at 15.25p yesterday. The net proceeds from the placing will be used to further strengthen the companys balance sheet as its partnering and strategic collaborations progressand will boost working capital during the progression of its pipeline portfolio.
() has signed a clinical and commercial agreement with a US life sciences group for its cutting edge gene-editing technology. Caribou Biosciences will use MaxCytes flow electroporation systems and the companys ExPERT platform in its allogeneic t-cell therapy programmes. MaxCyte will receive undisclosed development and approval milestones as well as sales-based payments and other licensing fees. This important agreement represents another key expansion for MaxCyte, emphasising the value of our technology platform to companies developing pioneering gene-editing and cell therapies, MaxCytes chief executive, Doug Doerfler said in a statement.
() has announced the commencement of a three-week field exploration programme from this weekend on the gold-focused Big Bear property in Ontario, Canada. The main market-listed company, which is focused on mineral exploration in Canada and Australia, said the three-week work sampling and mapping programme, which will build its understanding of possible drill and trench targets is commencing on May 10. It noted that the work will target both orogenic gold and volcanogenic massive sulphide (VMS) style mineralisation.
() said new positive data relating to its CTX cell therapy candidate have been published in the peer-reviewed scientific journal Stem Cells. The developer of cell-based therapeutics said the data was included in a paper entitled "Implantation of the clinical-grade human neural stem cell line, CTX0E03, rescues the behavioural and pathological deficits in the quinolinic acid-lesioned rodent model of Huntington's disease". It said the new data show for the first time that ReNeuron's CTX human neural stem cell line can rescue deficits associated with an accepted animal model of Huntington's disease, a progressive genetic brain disorder.
() has unveiled a new resource statement for the Beaconsfield gold mine in Tasmania. Total resources rise to 1.454mln tonnes at a grade of 10.3 grams per tonnes (g/t), for 483,000 ounces gold. There are 354,000 ounces in measured and inferred resources, 485,000 tonnes at 11.4 g/t in measured for 177,000 ounces and 492,000 tonnes at 11.2 g/t in indicated for 177,000 ounces. A further 477,000 tonnes at 8.4 g/t remains in the inferred resource category, and, the company told investors that significant additional gold potential is still to be assessed.
() has announced that Penny will become the new chair of its board with effect from February 1, 2021, replacing Richard Eyre who will complete nine years as its chairman on May 11, 2020. Ladkin-Brand, who has chaired the Next 15 Audit Committee since 2017, also becomes the companys Senior Independent Director with immediate effect. The group said its board has asked Eyre to continue in the post to the end of the current financial year, and, consequently, he will seek re-election at the AGM and be available to support a smooth transition. Ladkin-Brand is currently chief financial officer at (), the FTSE 250 global multi-platform media company, and she will be moving into a new role of chief strategy officer on June 1, 2020, and will step down from the groups board.
() said its portfolio firm Exscientia has entered into a collaboration with US research centre SRI International to expedite the discovery of molecules for a high value oncology target. The IP investor said the agreement will see the two firms implement a new approach to drug discovery using SRIs automated synthetic-chemistry system with Exscientia's Centaur Chemist system. Frontier IP owns a 2.3% stake in Exscientia.
Eden ResearchPLC () said it is poised to capitalise on new product and market opportunities in 2020 as it predicted more sales for its Cedroz product. Posting its results for the year endedDecember 31, 2019, the biopesticide specialist said it expected to build on the sales achieved in the territories where it received approvals during 2019 and early 2020, including sales for Cedroz in Spain, Italy, France, Belgium, the Netherlands and the United Kingdom where the applications for registrations have now been outstanding from the early part of 2019. The firm also said it expected US regulators to approve Cedroz and its Mevalone product during 2020, although the pace of approvals hasbeen slowed by the coronavirus (COVID-19) pandemic.
() has agreed to acquirea further 7% interest in the Otjozondu manganese mining project in Namibia. The transaction sees Premier buy a 7% interest in MN Holdings Limited, the projects owner, for US$700,000 paid in new shares. It will increase Premier Africans stake in MN to 19%. This further proposed increase in our holding in MNH is based on the same valuation formula applied to our initial acquisition, George Roach, Premier African's chief executive said in a statement released after the market close on Wednesday.
() has taken another important step towards the global launch of its phase III treatment for the rare skin condition epidermolysis bullosa (EB) by announcing its brand name. AP101 will be launched commercially as FILSUVEZ. This, alongside our recent completion of recruitment into the EASE study, represents further progress as we endeavour to develop a therapy for patients with EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment," Amryt chief executive, Dr Joe Wiley said in a statement.
() said it has noted the recent rise in its share price and confirms that it knows of no reason for this movement. As announced on May 1, 2020, the company has completed the sale of Anglo African Oil & Gas Congo S.A.U to Zenith Energy Limited on the terms set out in the announcement of April 17, 2020.
Silence Therapeutics PLC (LON:SLN), a leader in the discovery, development and delivery of novel RNA therapeutics for the treatment of serious diseases, said its annual general meeting will be held on June 9, 2020, at 10.00am at Herons Ghyll, Tilford Road, Tilford, Surrey GU10 2DD. It added that in order to comply with the UK Government's Stay at Home measures, shareholders will not be allowed to attend the meeting in person and are strongly encouraged to, therefore, submit their votes, in respect of all matters of business, via proxy as early as possible. If the situation changes then shareholders will be notified via the company's website at https://www.silence-therapeutics.com and via RNS announcement.
(LON:WBI_, the African focused forestry and timber trading company, has announced that following the release of the audited results for the year ended December 31, 2019 on April 30, the company has made their latest corporate presentation available from the investor centre of the company's website.
() (ASX:BSE), the African mineral sands producer, has announced that the latest investor update presentation is now available from the companys website - http://www.baseresources.com.au - and a pre-recorded webcast of that presentation can be viewed at https://edge.media-server.com/mmc/p/6av8h2ew
After a volatile Wednesday, the London market looks set to start flat for the last session of the short week.
CFD firm IG Markets calls the FTSE 100 up only 4 points, making the price 5,848 to 5851 with just over an hour to go until the start of trading.
With the Friday bank holiday looming and anticipation of the next government decisions on lockdown sentiments are tempered and trading activity may be somewhat muted without other external stimuli.
Thursdays diary will have some important update, not least BTs pending dividend decision, meanwhile, the policy decision is also due later today along with an inflation report.
Michael Hewson, analyst at CMC Markets, suggested that the central banks bond-buying campaign is far from done.
Todays inflation report and virtual press conference at 10am, is likely to paint a dark outlook for the UK economy, not only for this year, but also for the next few years as rising unemployment triggers a tsunami of defaults and bankruptcies.
The growth forecasts are likely to be moved into line with assessments from the likes of the OECD and the IMF, which suggests we could see a figure in the region of -7.5%. It was notable that Andrew Bailey didnt demur too much when a figure of -12% was put to him recently, however this was put to him within a range of -5% to -12%.
He added: With Brexit also a clear and present threat to both the UK and other European economies, the road ahead looks an extremely bumpy and potholed one, and as any driver will tell you, a road full of potholes will prevent you from picking up any sort of acceleration to a steady cruising speed.
Last night saw a mixed close for US equities as the Dow Jones Industrial Average gave up more than 200 points, or 0.91%, to finish at 23,664 and the S&P 500 dipped 0.7% to 2,848 whilst the Nasdaq Composite gained 0.5% to 8,854.
In Asia, Japans Nikkei 225 was a sliver higher at 19,624 and Hong Kongs Hang Seng was 0.76% lower at 23,954. The Shanghai Composite, meanwhile, dipped 0.32% to 2,858.
interest rate decision
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Finals: (), PLC ()
FTSE 100 ex-dividends to knock 0.79 points off the index: (), PLC ()
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Economic data: US jobless claims
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FTSE 100 closes up and nearing 6,000 as investor optimism continues - Proactive Investors UK