Morning Update: Canadas data gaps are hurting our ability to fight the pandemic – The Globe and Mail
By daniellenierenberg
Good morning,
Crucial data gaps are hurting Canadas ability to fight the COVID-19 pandemic, leaving Canadians in the dark about who is being infected or struggling with the devastated economy.
Canada has a long-standing problem of information gaps, The Globe and Mail found in a year-long series, and that has left us vulnerable during public health crises before. But now, these blind spots could blunt the federal economic rescue effort, hide inequities in deaths from the disease and slow our emergence from self-isolation in the months ahead.
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Father Victor Fernandes puts on personal protection equipment prior to visiting with a patient in the COVID-19 intensive care unit at St. Paul's hospital in downtown Vancouver on April 21, 2020.
JONATHAN HAYWARD/The Canadian Press
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Nova Scotia shooting: Premier Stephen McNeil is urging his mourning province to help investigators unravel questions around a gunmans weekend rampage. A new tip line was created specifically for the killings. He acknowledged there is anger over the RCMPs decision not to use the provincial emergency alert system during the 12-hour manhunt, but he asked people to be patient, and wait for answers.
New details are emerging about the chaos that ensued as police tried to capture the killer disguised as an RCMP officer. Audio recordings of first responders communicating on two-way radios provide a glimpse of frantic attempts to help the first victims in the village of Portapique.
A couple pays their respects at a memorial in Portapique, N.S., on April 22, 2020.
Andrew Vaughan/The Canadian Press
Economy: Saskatchewan has laid out a detailed, comprehensive plan to reopen its economy, and is the first province in the country to do so. On May 4, the five phases will begin, opening non-essential medical procedures, and the reopening of provincial parks, campgrounds and golf courses.
In Quebec, Premier Franois Legault is preparing to lay the groundwork next week for a plan to gradually restart the provinces economy and get children back to school.
Rent: Ottawa is proposing to offer commercial rent relief, in the form of loans for landlords of small and medium-sized businesses, that would cover up to 75 per cent of tenants payments for three months, according to sources familiar with the negotiations.
When it comes to investment properties, small landlords across Canada might not qualify for government assistance and are scrambling to figure out how to accommodate rent reductions while making their mortgage payments.
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World news:
Researchers at the University of Oxford are racing to develop a vaccine for COVID-19 and plan to make a million doses of it this summer. The team has been working since January, and clinical trials involving more than 500 volunteers began yesterday. The testing is expected to take several months, but the researchers have already teamed up with manufacturers globally to produce the doses September and millions more by the end of the year. The Globes Paul Waldie reports.
An aerial view of people queuing outside a bank in downtown Quito, Ecuador, on April 22, 2020.
RODRIGO BUENDIA/AFP/Getty Images
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Scheer, Tories refrain from criticizing MP accused of racist comments: People of Asian descent have faced a spike in hate crimes and slurs since the COVID-19 pandemic began in China last year and experts say the comments from an elected official give licence for the attacks to continue.
Child protection organizations seeing significant uptick in predators: In dark-web forums, sexual predators are increasingly discussing the COVID-19 pandemic as an opportunity to exploit children online as they spend more time out of school and on the internet.
Ontarios Serious Fraud Office investigates Bondfield: A special unit of Ontario police officers and prosecutors launched the investigation in 2019, looking into allegations of wrongdoing by a major builder of hospitals, transit stations and other public infrastructure across the province.
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Parents of teen girls killed by Paul Bernardo seek to obtain his file with the parole board: The two families filed for judicial review this month after their requests for the documents under access to information legislation were denied.
MPs seek to overcome hurdle in getting WHO adviser to testify: A parliamentary committee scrutinizing the response to the pandemic is working to get key World Health Organization adviser Bruce Aylward to testify. The WHOs legal counsel has said that Dr. Aylward cannot testify unless he receives authorization from WHO Director-General Tedros Adhanom Ghebreyesus.
World stocks fall on worries over EU stimulus details, coronavirus drug: Global shares fell on Friday, spurred by delays to an agreement on divisive details of the European Unions stimulus package and doubts about progress in the development of drugs to treat COVID-19. In Europe, Britains FTSE 100 was down 0.93 per cent around 6 a.m. ET. Germanys DAX and Frances CAC 40 fell 1.07 per cent and 1.03 per cent, respectively. In Asia, Japans Nikkei fell 0.86 per cent. Hong Kongs Hang Seng fell 0.61 per cent. New York futures were flat. The Canadian dollar was trading at 71.05 U.S. cents.
Canada must protect itself from Americas response to COVID-19
Robyn Urback: It is not implausible that Mr. Trump would retaliate in some sort of petty but potentially grave economic way on supply lines for essential goods, for example if Canada refuses to lift restrictions on non-essential travel if and when the President decides that time is up.
This Ramadan, in solitude, will be more meaningful than ever
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Fatima Al Fahim: But the pandemic need not dampen Ramadan spirits. Physical distancing gives us a reminder of the true meaning of the holy month.
The world has a big China problem now
Campbell Clark: We dont know precisely what happened in China in the early days of COVID-19, but we know some whistle-blowers were stifled and, for whatever reason, officials waited for days to tell the world after learning they faced a serious epidemic.
By Brian Gable
Brian Gable/The Globe and Mail
What you really need is a room edit, not a reno
Especially while in isolation, you may be looking for curatorial guidance, but are keen to avoid the expense of a full interiors overhaul. Some people would rather rip out a wall or buy a bigger house, when all it often takes is reimaging and reworking what you already have, says Joanna Teplin, the Nashville co-founder of the Home Edit. If you want to remodel, read about how you might be able to make the change with what you already have.
Snuppy, right, the first male dog cloned from adult cells by somatic nuclear cell transfer, and the male Afghan hound from which an adult skin cell was taken to clone Snuppy, are seen in this handout photo released in Seoul on Aug. 3, 2005.
Seoul National University via Reuters
Snuppy worlds first cloned dog is born
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If he were born today, Snuppy would be dubbed, in internet lingo, a very good pupper or an excellent doggo. Instead, Snuppy, the first successful clone of a dog, had to settle for merely being hailed as a breakthrough in biotechnology. A team of 45 South Korean researchers, led by stem-cell researcher Hwang Woo-suk, produced the pup using a process called somatic cell nuclear transfer with a cell from the ear of a male Afghan dog, Tai. Snuppy was named for Seoul National University (SNU) and puppy. While other mammals had been cloned successfully starting with Dolly the sheep in 1996 cloning mans best friend proved more challenging. The achievement suggested that, given time and expertise, almost any mammal could be reproduced. Defying concerns that clones would be rife with ailments, Snuppy was generally healthy. He fathered 10 pups by artificial insemination and produced, by stem-cell clone, a litter with three surviving pups. Snuppy died of cancer, a common fate in dogs, just days after his 10th birthday in 2015. Jessie Willms
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Morning Update: Canadas data gaps are hurting our ability to fight the pandemic - The Globe and Mail
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April 24th, 2020
AIVITA Biomedical Publishes Study Comparing Immune Responses and Associated Survivals Induced by Dendritic and Tumor Cell Vaccines – BioSpace
By daniellenierenberg
Findings confirmed that patient-specific autologous dendritic cell vaccines (DCV) induced a different immune response associated with longer survival than autologous tumor cell vaccines (TCV)
IRVINE, Calif.--(BUSINESS WIRE)-- AIVITA Biomedical, Inc., a biotechnology company specializing in innovative cell therapy applications, announced today the publication of a paper titled, Cytokine network analysis of immune responses before and after autologous dendritic cell and tumor cell vaccine immunotherapies in a randomized trial, in the Journal of Translational Medicine. Robert O. Dillman, M.D., chief medical officer at AIVITA, and Gabriel I Nistor, M.D., chief scientific officer at AIVITA, authored the article.
The publication provides insight into the innate and adaptive immune responses induced by patient-specific autologous dendritic cell vaccines (DCV) and autologous tumor cell vaccines (TCV), and their impact on survival. DCV was associated with a multipronged innate and adaptive immune response and correlated with improved survival compared to TCV.
In a randomized Phase 2 trial conducted in patients with melanoma, blood samples were obtained at one week before and one week after a course of three weekly injections, which either included dendritic cells loaded ex vivo with antigens from autologous irradiated tumor-initiating cells (DCV), or autologous irradiated tumor-initiating cells alone (TCV). Cytokine network analysis techniques used to analyze the serologic immune responses generated by each immunotherapy confirmed they triggered differing responses. The results help provide insight into a potential underlying immunologic mechanism of action that contributes to improved survival in DCV-treated patients.
This analysis reinforces conclusions from our patient-specific cancer vaccine survival data, which suggested that ex-vivo processing of the same tumor antigens by autologous dendritic cells induces a more advantageous immune response than antigen-only based tumor cell vaccines, said Dr. Nistor. This is reassuring as we continue to further optimize our unique approach in which we use enhanced autologous dendritic cells for targeting each patients own tumor.
AIVITA is currently conducting three independent clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the development of its cancer therapeutic pipeline.
About AIVITAS Clinical Trials
OVARIAN CANCER
AIVITAs ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.
Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.
For additional information about AIVITAs AVOVA-1 trial patients can visit: http://www.clinicaltrials.gov/ct2/show/NCT02033616
GLIOBLASTOMA
AIVITAs glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.
Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.
For additional information about AIVITAs AV-GBM-1 trial please visit: http://www.clinicaltrials.gov/ct2/show/NCT03400917
MELANOMA
AIVITAs melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITAs tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.
Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.
For additional information about AIVITAs AV-MEL-1 trial please visit: http://www.clinicaltrials.gov/ct2/show/NCT03743298
About AIVITA Biomedical
AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITAs skin care products support the treatment of people with cancer.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200423005260/en/
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AIVITA Biomedical Publishes Study Comparing Immune Responses and Associated Survivals Induced by Dendritic and Tumor Cell Vaccines - BioSpace
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April 24th, 2020
Lozier praises promising, and ethical, blindness study – OneNewsNow
By daniellenierenberg
New research results show promise in treating people who are blind.
The National Eye Institute funded the study, which is research considered to be ethical.
Dr. David Prentice of the Charlotte Lozier Institute says there have been discussions over using adult stem cells to restore sight, which he calls a different tack for advancing science and medicine.
It's still an ethical way to go about this, he observes. There's no embryonic stem cells, no fetal tissue, none of this unethical type of research direction.
What the scientists did was turn a skin cell directly into a photoreceptor for vision then transplanted it.
Prenticeadvises the testing is very preliminary after the experiment on mice.
But what they find was when they transplanted this newly formed type of vision cell into the eyes of these blind mice, he says, they restored their vision.
The researchers applied chemicals that transformed one cell type into another needed for vision, and there is now potential to help people with all forms of vision blindness or vision correction, which would include macular degeneration and other retinal disorders.
Editor's note: Original posting attribute comments to wrong person.
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Lozier praises promising, and ethical, blindness study - OneNewsNow
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April 24th, 2020
How to care for your nails at home now that you can’t go to the salon – AsiaOne
By daniellenierenberg
Just because you cant head to a nail salon right now doesnt mean you should neglect your hands, feet and nails. Plus, the excessive hand washing youve been doing still the most reliable way to protect yourself and your family from Covid-19 can also strip skin of its natural oils and leave it dry. Heres what you can do:
If youre lazy, just use a body scrub in the shower, starting from the feet up. But for a little DIY pampering, start with a foot soak to soften rough heels and soles, then use a foot scrub.
This is important, especially for the hands, as the skin there is thinner than the rest of the body. Its also one of the first places to show signs of ageing. Plus, if the skin on your hands and feet are extremely dry, it could develop micro cracks that allow germs in, making you unwell.
Did you know that massaging cuticle oil on your cuticles and nails every day can improve blood flow to the nail matrix (the root), which makes your nails strong and healthy? If you tend to forget, keep the bottle by your WFH work desk or at your bedside as a nightly reminder.
Here are seven treats to get your hands, feet and nails looking great, when youre stuck at home:
Sweet almond oil and shea butter nourish skin, strengthen nails, and keep your hands soft.
Available atwww.thebodyshop.com/en-sg/and when stores re-open, at The Body Shop.
Not everyone likes using a thick, heavy cream, especially when you dont have the aircon on when you work from home. The heat just makes it all the more sticky.
This lotion is lightweight yet intensively hydrates hands with organic shea butter, USDA-certified organic jojoba seed oil and rice bran oil, yet remains lightweight on the skin.
The latter ingredient contains vitamin E, which protects your hands against UV damagewhich helps give added projection if you work by the window.
Available atwww.thann.com.sg
ALSO READ:9 nail products to help you get a salon-quality manicure at home
A five-oil blend of jojoba, sunflower, argan, pomegranate and tamu moisturise dry cuticles, keeping nails healthy, and soothing skin. We love the rollerball for fuss-free application and the delicate citrus and rose geranium scent.
Available atwww.net-a-porter.com
You wear the mask like socks that reach up to mid-shin, taping the tabs down for a snug fit. The inside of the mask contains its formula of 7 essential oils and 11 herbs (including spearmint, eucalyptus, grapefruit, bergamot, juniper and thyme) to relieve tired feet and legs, and keep them soft and hydrated.
Available atwww.ksisters.sg
For quick exfoliation in the shower, use this creamy body scrub. It contains finely milled pumice stone and bamboo stem to gently buff away dead skin cells and dirt. Skin feels smoother and softer, from top to toe.
Available atwww.aesop.com/sg/andwww.net-a-porter.com
A body lotion is the easiest way to ensure that every bit of skin gets hydration, not just your hands and feet. This one contains nourishing plant oils and butters, together with amino acids, ceramides and antioxidants that lock in moisture, soothe dryness and itch, and protect skin from free radical damage.
Available atwww.sephora.sgand when stores re-open, at Sephora.
An intensive treatment for your hands, the mask contains two layers: The inner layer contains Bulgarian rose, shea butter and rose hip oil to nourish while the outer protective foil creates a warming effect to enhance absorption of the active ingredients. Hands are soft, supple and conditioned in 15 minutes.
Available atwww.sephora.sgand when stores re-open, at Sephora.
For the latest updates on the coronavirus, visithere.
This article was first published in Her World Online.
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April 24th, 2020
Incyte Announces Pivotal REACH2 Study Data Published in NEJM Highlight Superior Efficacy of Ruxolitinib (Jakafi) versus Best Available Therapy in…
By daniellenierenberg
- Phase 3 REACH2 data demonstrate that ruxolitinib (Jakafi) improves outcomes across a range of efficacy measures in patients with steroid-refractory acute graft-versus-host disease (GVHD) compared to best available therapy (BAT)
- Results show a significantly greater overall response rate (ORR) in patients treated with ruxolitinib (62%) compared to BAT (39%) 1,2
- GVHD is a serious and common complication of allogeneic stem cell transplants with a one-year mortality rate as high as 80% in patients who develop acute GVHD3-5
- The results, published in The New England Journal of Medicine, were also selected for an oral presentation during the Presidential Symposium at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting to be held 30 August to 2 September in Madrid, Spain
Incyte (Nasdaq:INCY) today announced that data from the Phase 3 REACH2 study have been published in The New England Journal of Medicine demonstrating that ruxolitinib (Jakafi) improves outcomes across a range of efficacy measures in patients with steroid-refractory acute graft-versus-host disease (GVHD) compared to best available therapy (BAT). The results of REACH2, the first Phase 3 study of ruxolitinib in acute GVHD to have met its primary endpoint, reinforce findings from the previously-reported Phase 2 REACH1 study.
In REACH2, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) vs. BAT (62% vs. 39%; p<0.001) at Day 28, the primary endpoint of the study. For the key secondary endpoints, patients treated with ruxolitinib maintained significantly higher durable ORR (40% vs. 22%; p<0.001) at Day 56. In addition, ruxolitinib was associated with longer median failure free survival (FFS) than BAT (5.0 months vs. 1.0 months; hazard ratio 0.46, 95% CI, 0.35 to 0.60) and showed a positive trend with other secondary endpoints, including duration of response1,2.
No new safety signals were observed, and the ruxolitinib safety profile in REACH2 was consistent with that seen in previously reported studies in steroid-refractory acute GVHD. The most frequently reported adverse events among study participants were thrombocytopenia and anemia. While 38% and 9% of patients required ruxolitinib and BAT dose modifications, the number of patients who discontinued treatment due to AEs was low (11% and 5%, respectively)1,2.
"The results from the REACH2 study reinforce findings from the pivotal REACH1 trial and demonstrate the potential that ruxolitinib has to effectively and safely improve outcomes for patients with GVHD," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "We are committed to continuing our research in GVHD with the goal of providing more effective treatment options for patients living with this disease, and look forward to the results of the REACH3 study in steroid-refractory chronic GVHD later this year."
The REACH2 data were also accepted as an oral presentation as part of the Presidential Symposium at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting to be held 30 August to 2 September in Madrid, Spain.
"Patients with acute graft-versus-host disease face life-threatening challenges with limited treatment options, particularly for the nearly half of individuals who do not respond to initial steroid therapy," said Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany. "These new data from REACH2 showing superiority of ruxolitinib over current standard-of-care therapies add to a growing body of evidence on how targeting the JAK pathway can be an effective strategy in this difficult-to-treat condition."
In 2019, Jakafi (ruxolitinib) was approved by the U.S. Food and Drug Administration for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older, based on the positive results of the Phase 2 REACH1 trial6. The Phase 3 REACH3 study in patients with steroid-refractory chronic GVHD is ongoing and results are expected in the second half of this year. Jakafi is marketed by Incyte in the U.S.; ruxolitinib (Jakavi) is licensed to Novartis ex-U.S.
The NEJM publication of the REACH2 results is available online.
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About REACH2
REACH2 (NCT02913261), a randomized, open-label, multicenter Phase 3 study sponsored by Novartis and conducted in collaboration with and co-funded by Incyte , is evaluating the safety and efficacy of ruxolitinib compared with best available therapy in patients with steroid-refractory acute GVHD.
The primary endpoint was overall response rate (ORR) at Day 28, defined as the proportion of patients demonstrating a best overall response (complete response or partial response). Secondary endpoints include durable ORR at Day 56, ORR at Day 14, duration of response, overall survival and event-free survival, among others. For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT02913261.
About REACH
The REACH clinical trial program evaluating ruxolitinib in patients with steroid-refractory GVHD, includes the randomized pivotal Phase 3 REACH2 and REACH3 trials, conducted in collaboration with Novartis. The ongoing REACH3 trial is evaluating patients with steroid-refractory chronic GVHD with results expected later this year. For more information about the REACH3 study, please visit https://clinicaltrials.gov/ct2/show/NCT03112603.
The REACH program was initiated with the Incyte-sponsored REACH1 trial, a prospective, open-label, single-cohort, multicenter, pivotal Phase 2 trial (NCT02953678) evaluating Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD. For more information about the study, including trial results, please visit https://clinicaltrials.gov/show/NCT02953678.
About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.
Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.
The most common side effects of Jakafi include: for certain types of MF and PV - low platelet or low red blood cell counts, bruising, dizziness, headache, and diarrhea; and for acute GVHD low platelet, red or white blood cell counts, infections, and fluid retention.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have a high level of fat in your blood (high blood cholesterol or triglycerides), had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider.
Women should not take Jakafi while pregnant or planning to become pregnant. Do not breast-feed during treatment with Jakafi and for 2 weeks after the final dose.
Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at http://www.jakafi.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements about the REACH2 data, when results from the REACH3 study will be available, the effect of the REACH2 results on patients with GVHD, and the overall REACH program, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Companys current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Companys dependence on its relationships with its collaboration partners; the efficacy or safety of the Companys products and the products of the Companys collaboration partners; the acceptance of the Companys products and the products of the Companys collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Companys reports filed with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019. The Company disclaims any intent or obligation to update these forward-looking statements.
References
View source version on businesswire.com: https://www.businesswire.com/news/home/20200422005739/en/
Contacts
Incyte Contacts Media Jenifer Antonacci+1 302 498 7036jantonacci@incyte.com
Catalina Loveman+1 302 498 6171cloveman@incyte.com
Investors Michael Booth, DPhil+1 302 498 5914mbooth@incyte.com
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April 24th, 2020
What Factors Influence Hematological Recovery in Patients Who Receive CAR-T Therapies? – Cancer Therapy Advisor
By daniellenierenberg
A few weeks afterreceiving chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, many patientsexperience prolonged reductions in blood cell counts, possibly making them morevulnerable to infections.
Two recent studies characterized the extent and duration of postCAR-T cytopenia among patients receiving CAR-T therapy for hematological malignancies with 1 study offering insights on some of the possible factors that may influence hematological count recovery.
Whats important to know is that by day 90, mostpatients recover, noted UroosaIbrahim, MD, stemcell transplantation and cellular therapy fellow at the Tisch Cancer Instituteof the Icahn School of Medicine at Mount Sinai,New York, who coauthored 1 of the studies. Were supporting them for [approximately]3 months [with treatment], but then theyll recover, which is good to know.
One study by MemorialSloan Kettering Cancer Center (MSKCC) researchers followed 83 adult patientswho received CAR-T therapy: 40 patients received 1 of 2 Food and DrugAdministration (FDA)-approved therapies, axicabtageneciloleucel (axi-cel; Yescarta) ortisagenlecleucel (tisa-cel; Kymriah), to treat relapsed/refractory B-cell lymphoma.
The remainder comprised 37 patients with relapsed/refractory B-cell acute lymphoblastic leukemia who were currently enrolled in a clinical trial in which they received an experimental CAR-T therapy where cells express the 19-28z CAR construct (ClinicalTrials.gov Identifier: NCT01044069), and 6 multiple myeloma patients who received a different experimental CAR-T construct that targets the B-cell maturation antigen (BCMA) (ClinicalTrials.gov Identifier: NCT03070327). The findings were presented at the annual Transplantation and Cellular Therapy Meetings of ASCT and CIBMTR in February 2020.1
By 1 month, theresearchers observed that 24% of patients experienced a complete recovery ofhemoglobin, platelets, absolute neutrophil count, and white blood cell counts recovery being defined as reaching safe levels, and without requiringtransfusions or treatment with growth factors.
Recovery of hemoglobinwas noted in 61% of patients, platelets in 51% of patients, absolute neutrophilcount in 33% of patients, and white blood cell count in 28% of patients.Examining 41 patients at 3 months, those figures were 93%, 90%, 81%, and 59%,respectively, and overall, 56% saw a complete blood count recovery.
The results werebroadly consistent with recent research by Dr Ibrahim and Keren Osman, MD,associate professor and director of medicine at the Icahn School of Medicine atMount Sinai and director of cellular therapy service in the bone marrow andstem cell transplantation program at the schools Tisch Cancer Institute. Thatstudy comprised 50 patients 41 with multiple myeloma and 9 with diffuse largeB-cell lymphoma who received either axicabtagene ciloleucel, or 1 of 2 experimentalanti-BCMA CAR-T therapies, bb2121 or bb21217.
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What Factors Influence Hematological Recovery in Patients Who Receive CAR-T Therapies? - Cancer Therapy Advisor
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April 24th, 2020
Robust response by NIT-T alumni to tackle Covid-19 pandemic – The Hindu
By daniellenierenberg
Alumni members of National Institute of Technology - Tiruchi (NIT-T) holding key positions in tech companies across the globe have responded overwhelmingly through their knowledge support, innovative devices, fund mobilisation, and production of personal protection equipment for dealing with the COVID-19 pandemic.
An associate of Global Consortium of Cell Therapy Companies, Stempeutics, an Indian stem cell company of which B. N Manohar, an alumnus of ECE 1977 batch is the Chief Executive Officer, will shortly be supplying clinical-grade Mesenchymal Stem Cells (multi-potent stem cells found in the bone marrow used for making and repairing skeletal tissues) to those in need. Manufactured in the Manipal GMP facility under approval of Drug Controller General of India, the multi-potent stem cells have been found to reduce the symptoms of pneumonia induced by COVID-19 and halt its advancement to Acute Respiratory Distress Syndrome, NIT-T Director Mini Shaji Thomas said.
S. K. Ramesh, an alumnus of 1981 batch ECE holding a senior position in California State University, Northridge, is involved along with his colleagues in creation of life saving face shields and other personal protection equipment for donating the same to healthcare workers in hospitals throughout Southern California.
Blooom Energy, founded by K. R. Sridhar, who had completed his mechanical engineering degree from the then Regional Engineering College Tiruchi, and subsequently did his masters degree in Nuclear Engineering, and Ph.D. in Mechanical Engineering from the University of Illinois, Urbana-Champaign, has undertaken the task of repairing ventilators on a bulk scale in partnership with Stanford Health Care.
Chief Innovation Officer at Dulso, United Arab Emirates, Madhumohan Sreeram, an alumnus of NIT-T who had completed B.Tech in Chemical Engineering in 1982, has been in the forefront in carrying out sanitisation of the municipality of Dubai after identifying a suitable disinfectant QUATPLUS TB, which is a Quaternary Ammonium Compound product approved by United States Environmental Protection Agency and American chemistry councils Center Biocide Chemistry (CBC) and has been listed in their recommended EPA pre-approved products for COVID-9 disinfection application.
Richard Sekar, an alumnus who had completed Production Engineering in 1983 leads Warriors Against Virus a team of 371 volunteers in the Bay Area, USA, for stitching facial masks for hospital requirement. IcarusNova, of which Sapna Behar, an alumna (1990, EEE), is the Director and Founder, has partnered with LifeSignals to design a wireless biosensor-based patch, with ISO 13485 accreditation, for early detection and continuous monitoring of COVID-19 symptoms. The patches when affixed on the chest area can monitor the temperature, breathing rate, trace ECG and heart rate as a real time data. The data can be transferred to the users phone through an app. The system reduces the risk of contamination between patients and other individuals.
Admiral Superintendent of Naval Dockyard, Vishakapatnam, Sreekumar Nair (ECE, 1986), has led a team to design an innovative portable multi-feed oxygen manifold using a six-way radial header fitted to a single cylinder. This becomes essential when the existing hospital facilities for critical care management becomes limited and a need arises for catering to multiple patients. Rapid trials have been done at Naval Hospital INHS Kalyani. The entire assembly could be set up within 30 minutes.
Appreciating the efforts of the alumni members, Prof. Mini Shaji Thomas said the various contributions in diverse sectors was a matter of pride.
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April 24th, 2020
Spinal Cord Trauma Treatment Market to Grow at Stellar CAGR 3.7% During the Forecast Period 2025 – MENAFN.COM
By daniellenierenberg
(MENAFN - iCrowdNewsWire) Apr 23, 2020
' Spinal Cord Trauma Treatment Market: Global Industry Analysis 2012 2016 and Forecast 2017 2025' is the recent report of Persistence Market Research that throws light on the overall market scenario during the period of eight years, i.e. 2017-2025. According to this report, Global spinal cord trauma treatment market is expected to witness significant growth during the forecast period.
This growth is expected to be primarily driven by increasing incidence of spinal cord trauma, and increasing government support to reduce the burden of spinal cord injuries. Additionally, development of nerve cells growth therapy is expected to boost the market in near future.
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Company Profiles
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The global market for spinal cord trauma treatment is is estimated to be valued at US$ 2,276.3 Mn in terms of value by the end of 2017. The global spinal cord trauma treatment market is expected to expand at a CAGR of 3.7% over the forecast period to reach a value of US$ 3,036.2 Mn by 2025end.
Global Spinal Cord Trauma Treatment Market: Trends
Global Spinal Cord Trauma Treatment Market: Forecast by End User
On the basis of end user, the global spinal cord trauma treatment market is segmented into hospitals and trauma centers. Hospitals segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period.
Hospitals and trauma centers segments are expected to approximately similar attractive index. Hospitals segment accounted for 53.2% value share in 2017 and is projected to account for 52.5% share by 2025 end.
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Global Spinal Cord Trauma Treatment Market: Forecast by Injury Type
On the basis of injury type, the global spinal cord trauma treatment market is segmented into complete spinal cord injuries and partial spinal cord injuries.
Partial spinal cord trauma treatment segment is expected to show better growth than the completed spinal cord treatment segment due to higher growth in the incidence rate of partial spinal cord trauma than the complete spinal cord trauma. With US$ 1,870.3 Mn market value in 2025, this segment is likely to expand at CAGR 3.8% throughout the projected period.
Global Spinal Cord Trauma Treatment Market: Forecast by Treatment Type
On the basis of treatment type, the global spinal cord trauma treatment market is segmented into corticosteroid, surgery, and spinal traction segments.
Surgery segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period. Surgery segment is the most attractive segment, with attractiveness index of 2.6 over the forecast period.
Global Spinal Cord Trauma Treatment Market: Forecast by Region
This market is segmented into five regions such as North America, Latin America, Europe, APAC and MEA. Asia-Pacific account for the largest market share in the global spinal cord trauma treatment market.
Large patient population due to the high rate of road accidents and crime is making the Asia Pacific region most attractive market for spinal cord trauma treatment. On the other hand, MEA and Latin America is expected to be the least attractive market for spinal cord trauma treatment, with attractiveness index of 0.3 and 0.5 respectively over the forecast period.
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Molecular Diagnostics Market
Molecular Diagnostics Market Segmentation by Key Players Novartis AG, Roche Diagnostics, QIAGEN, Siemens Healthcare, Abbott Laboratories, Inc., Gen-Probe, Inc. (Hologic Inc.), Cepheid, Inc., Beckman Coulter, Inc., Becton, Dickinson & Company, Myriad Genetics, Inc., and bioMerieux.
Next-Generation Sequencing Market
Next Generation Sequencing Market Segmented by(By Application Whole-genome Sequencing ,Exome Sequencing,Targeted Resequencing,De Novo Sequencing,RNA Sequencing,ChIP Sequencing,Methyl Sequencing,Others);By Technology- Targeted Sequencing & Resequencing,Whole Genome Sequencing,Whole Exome Sequencing.
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April 24th, 2020
A Tribute to Max Randell, Gene Therapy Pioneer – PLoS Blogs
By daniellenierenberg
I awoke on Monday morning to the sad news that Max Randell had passed away on April 18. He would have been 23 on October 9.
Maxie wasnt expected to live past the age of 8, or even much past toddlerhood, according to some doctors. But gene therapy, and his incredible family, had something to say about that. COVID-19 didnt claim him his body just tired of fighting.
Max Randells legacy is one of hope, to the rare disease community whose family members step up to participate in the clinical trials that lead to treatments. In this time of the pandemic, attention has, understandably, turned somewhat away from the many people who live with medical limitations all the time. Ill explore that story next week.
A Devastating Diagnosis
Max was diagnosed at 4 months of age with Canavan disease, an inherited neuromuscular disease that never touched his mind nor his ability to communicate with his eyes, even though his body increasingly limited what he could do. Fewer than a thousand people in the US have the condition.
Canavan disease is an enzyme deficiency that melts away the myelin that insulates brain neurons. Gene therapy provides working copies of the affected gene, ASPA.
Babies with Canavan disease are limp and listless. Most never speak, walk, or even turn over. Yet their facial expressions and responses indicate an uncanny awareness. A child laughs when his dad makes a fart-like noise; a little girl flutters her fingers as if they are on a keyboard when a friend plays piano. Theyre smart.
Today, with excellent speech, occupational, and physical therapy and earlier diagnosis, people with Canavan disease can live into their teens or twenties. Those with mild mutations live even longer.
Maxs passing is a tragedy, but he taught researchers about gene therapy to the brain. And that may help others.
Gene Therapy for Canavan
Max had his first gene therapy at 11 months of age and a second a few years later, after slight backsliding when clinical trials halted in the wake of the death of Jesse Gelsingerin a gene therapy trial for a different disease.
Ive written about Maxs journey through many editions of my human genetics textbook, in my book ongene therapy, and in several DNA Science posts, listed at the end.
Ive had the honor to attend two of Maxs birthday parties, which celebrate Canavan kids and the organization that his family founded, Canavan Research Illinois. At one party I brought along birthday cards that students whod read my gene therapy book made for him. And his grandma Peggy, who emailed me of his passing this past Monday, showed me how Max communicated with eyeblinks of differing duration and direction.
Heres what his mom Ilyce wrote about one yearly gathering:
This year will be the 20th Annual Canavan Charity Ball. Each year as I plan this event Im faced with the undeniable reality that theres a chance Maxie wont be here by the time the day rolls around. With each passing year this fear grows stronger and it becomes increasingly difficult to put into print that our annual event is in honor of Maxies birthday. Ive been talking to Maxie a lot lately about his life. He feels happy, strong, loved, content, productive, and fulfilled and he is looking forward to his upcoming 21st birthday. Im excited to celebrate this incredible milestone.
Maxs parents and brother Alex have had the unusual experience of time, of being able to watch their loved one as the years unfolded following gene therapy. They were able to see more subtle improvements than can the parents whose children have more recently had gene therapy to treat a brain disease. Parents watch and wait and hope that language will return, or that a child will become more mobile or less hyperactive, depending on the treated condition. The changes may be subtle, or slow, or restricted and thats what Max taught the world.
For him, the viruses that ferried the healing genes into his brain seem to have gathered at his visual system. His parents noticed improvements in the short term, just before his first birthday, as well as long term.
Within two to three weeks, he started tracking with his eyes, and he got glasses. He became more verbal and his motor skills improved. His vision is still so good that his ophthalmologist only sees him once a year, like any other kid with glasses. She calls him Miracle Max, Ilyce told me in 2010.
In 2016 I heard from Ilyce again:
I wanted to give you an update on Maxie. Hes going to be 19 on October 9th. He graduated from high school in June and is beginning a work program on Monday. Its been very exciting to watch him grow into a young man!
Max had an appointment with his ophthalmologist this week and his vision continues to improve. His doctor said that the gene is still active in his brain because his optic nerve shows absolutely no signs of degeneration and looks the same each year. I wish we could have been able to express the gene throughout more of his brain, but I am grateful for the treatments because of the progress hes made.
Even though gene therapy wasnt a cure for Max, the things we are experiencing definitely give me a lot of hope that once the delivery system is perfected, I can see a potential cure for Canavan disease in the future. Just knowing that the gene is still there 15 years later gives me confidence that a one-time gene transfer would actually work!
Maxs gene therapy circa 2002 targeted less than 1% of brain cells, with fewer viral vectors than are used to deliver healing genes in todays clinical trials. But it looks like some of the vectors may have made their way beyond the optic nerves, judging by the interest in math he had in high school and his critical thinking skills.
A Choice of Gene-Based Therapies
When the Randell family decided to pursue gene therapy, it was pretty much the only game in town. Thats changed.
Only two gene therapies have been approvedin the U.S. But a search at clinicaltrials.gov yielded 602 entriesdeploying the technology. The list still rounds up the usual suspects of years past mostly immune deficiencies, eye disorders, or blood conditions, with a few inborn errors of metabolism.
But one clinical trial mentions the gene-editing tool CRISPR, which can replace a mutant gene, not just add working copies as classical gene therapy does. TheCRISPRtrial is an experiment on stem cells removed from patients with Kabuki syndrome, which affects many body systems.
Spinal muscular atrophy now has two FDA-approved treatments, one an antisense therapy (Spinraza) that silences a mutation and the other (Zolgensma) a gene therapy that infuses copies of the functioning gene. Without treatment, the destruction of motor neurons in the spinal cord is usually lethal by age two.
In 2018, FDA approved the first drug based on RNA interference (RNAi), yet another biotechnology. It silences gene expression, which is at the RNA rather than the DNA level of the other approaches. Onpattro treats the tingling, tickling, and burning sensations from the rare condition hereditary transthyretin-mediated amyloidosis.
When I wrote my book on gene therapy in 2012, the technology was pretty much the only choice of research to pursue besides protein-based therapies like enzyme replacement. Now families raising funds for treatments for single-gene diseases can add antisense, RNAi, and CRISPR gene editing to the list of possibilities.
In any battle, a diversity of weapons ups the odds of defeating the enemy.
RIP Max Randell.
DNA Science posts:
Fighting Canavan: Honoring Rare Disease Week
A Brothers Love Fights Genetic Disease
Gene Therapy for Canavan Disease: Maxs Story
Celebrating the Moms of Gene Therapy
To support research:Canavan Research Illinois
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April 24th, 2020
4 Benefits of Stem Cell Therapy that you will Love to Discuss in Future – The Crypto Coin Discovery
By daniellenierenberg
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The benefits of Stem cells therapy vary, some of the benefits of stem cells are because of their potential in the treatment of medical conditions, but it is not the only way they can be utilized. A few of the benefits are as follows: To know what is a Stem Cell Therapy.
Medically, stem cells are used in therapies to treat certain diseases and conditions, many treatments require a transplant of organs and tissues but the organs and tissues are donated and the waiting list for donation is quite long. People stay on the transplant lists for years and many dont live to see their name move up the list or are not viable to receive donor organs or tissues, and in such cases stem cells can provide an effective and faster and better alternative in some diseases. The most popular form of stem cell therapy is the bone marrow transplant, and many others are considered safe in treatments of conditions and diseases like:
There are many other stem cell therapies but not all of them have been approved as safe and effective. But like in the case of a burn victim, the replacement of the burned area with stem cells can be utilized to make new tissues and save the trouble of finding a tissue donor. It is a very painful experience and everything that can be done should be done to lessen the pain and start the healing process quickly for the sake of the patient.
Research done on animals like dogs and horses and cats showed us that this form of research not only advances the development of stem cell therapies and treatments; for the benefit of veterinary medicine, but also resulted to be very beneficial for human treatments as well.
Animals that have diseases that nearly mimic the ones humans have as well are used as ideal models to experiment the development of stem cell therapies in medical conditions that humans and animals both have, like ligament injuries or stroke etc.
Diseases like cancer and conditions like birth defects are quite common these days so, many clinical and experimental trials are popping up to better fight these diseases. Scientists are now looking for ways that they can use to come up with stem cell treatments to better develop the human body when it is suffering from conditions like birth defects.
They are trying to study how the stem cells transform or separate into a wide range of specialized cells so that they can be utilize them in the treatment of certain diseases and conditions.
Stem cells have a huge potential in the testing of drugs as they are relatively safe and dont put anyone in harms way, drugs are now first tested on stem cells and then on animals and humans if the test on stem cells goes well.
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April 22nd, 2020
FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments – Herald-Mail Media
By daniellenierenberg
SILVER SPRING, Md., April 22, 2020 /PRNewswire/ --Today, the U.S. Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body. Patients must have received at least two prior therapies before taking Trodelvy.
"Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. "There is intense interest in finding new medications to help treat metastatic triple-negative breast cancer. Today's approval provides patients who've already tried two prior therapies with a new option."
Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, meaning that the drug targets the Trop-2 receptor that helps the cancer grow, divide and spread, and is linked to topoisomerase inhibitor, which is a chemical compound that is toxic to cancer cells. Approximately two of every 10 breast cancer diagnoses worldwide are triple-negative. Triple-negative breast cancer is a type of breast cancer that tests negative for estrogen receptors, progesterone receptors and human epidermal growth factor receptor 2(HER2) protein. Therefore, triple-negative breast cancer does not respond to hormonal therapy medicines or medicines that target HER2.
"As part of FDA's ongoing and aggressive commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease," said Pazdur. "At this critical time, we continue to expedite oncology product development. This application was approved more than a month ahead of the FDA goal date an example of that commitment. Our staff is continuing to meet with drug developers, academic investigators, and patient advocates to push forward the coordinated review of treatments for cancer."
The FDA approved Trodelvy based on the results of a clinical trial of 108 patients with metastatic triple-negative breast cancer who had received at least two prior treatments for metastatic disease. The efficacy of Trodelvy was based on the overall response rate (ORR) which reflects the percentage of patients that had a certain amount of tumor shrinkage. The ORR was 33.3%, with a median duration of response of 7.7 months. Of the patients with a response to Trodelvy, 55.6% maintained their response for 6 or more months and 16.7% maintained their response for 12 or more months.
The prescribing information for Trodelvy includes a Boxed Warning to advise health care professionals and patients about the risk of severe neutropenia (abnormally low levels of white blood cells) and severe diarrhea. Health care professionals should monitor patient's blood cell counts periodically during treatment with Trodelvy and consider treatment with a type of therapy called granulocyte-colony stimulating factor (G-CSF), which stimulates the bone marrow to produce white blood cells called granulocytes and stem cells and releases them into the bloodstream, to help prevent infection, and should initiate anti-infective treatment in patients with febrile neutropenia (development of fever when white blood cell are abnormally low).
Additionally, health care professionals should monitor patients with diarrhea and give fluid, electrolytes, and supportive care medications, as needed. Trodelvy may need to be withheld, dose reduced or permanently discontinued for neutropenia or diarrhea. Trodelvy can cause hypersensitivy reactions including severe anaphylactic (allergic) reactions. Patients should be monitored for infusion-related reactions and health care professionals should discontinue Trodelvy if severe or life-threatening reactions occur. If patients experience nausea or vomiting while taking Trodelvy, health care professionals should use antiemetic preventive treatment, to prevent nausea and vomitting. Patients with reduced uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) activity are at increased risk for neutropenia following initiation of Trodelvy treatment.
The most common side effects for patients taking Trodelvy were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia (hair loss), constipation, decreased appetite, rash and abdominal pain.
Women who are pregnant should not take Trodelvy because it may cause harm to a developing fetus or newborn baby. The FDA advises health care professionals to inform females of reproductive age to use effective contraception during treatment with Trodelvy and for 6 months after the last dose. Male patients with female partners of reproductive potential should also use effective contraception during treatment with Trodelvy and for three months after the last dose.
Trodelvy was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Trodelvy's clinical benefit.
The FDA granted this application Priority Review andBreakthrough Therapydesignation, which expedites the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Trodelvy was also granted Fast Trackdesignation, which expedites the review of drugs to treat serious conditions and fill an unmet medical need.
The FDA granted approval of Trodelvy to Immunomedics, Inc.
Additional Resources:
Media Contact:Nathan Arnold, 301-796-6248Consumer Inquiries: Emailor 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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April 22nd, 2020
Cell Transplant Market to Witness Huge Growth by 2025 | CBR Systems, Escape Therapeutics, Cryo-Save – Research Columnist
By daniellenierenberg
A New Syndicate Global Cell Transplant Market Study is added in HTF MI database compiled covering key business segments and wider geographical scope to get deep dive analysed market data. The study brings a perfect bridging between qualitative and statistical data ofCell Transplant market. The study provides historical data (i.e. Consumption** & Value) from 2014 to 2019 and forecasted till 2026*. Some are the key & emerging players that are part of coverage and have being profiled are Regen Biopharma, Global Cord Blood Corporation, CBR Systems, Escape Therapeutics, Cryo-Save, Lonza Group, Pluristem Therapeutics & Stemedica Cell Technology.
Know how you are perceived in comparison to your competitors like Regen Biopharma, Global Cord Blood Corporation, CBR Systems, Escape Therapeutics, Cryo-Save, Lonza Group, Pluristem Therapeutics & Stemedica Cell Technology; Get an accurate view of your business in Global Cell Transplant Marketplace.
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Market Dynamics:
Set of qualitative information that includes PESTEL Analysis, PORTER Five Forces Model, Value Chain Analysis and Macro Economic factors, Regulatory Framework along with Industry Background and Overview
Key Highlights that HTF MI is bringing with this Study Revenue splits by most promising business segments. [By Type (, Peripheral Blood Stem Cells Transplant (PBSCT), Bone Marrow Transplant (BMT) & Cord Blood Transplant (CBT)), By Application (Hospitals, Clinics & Others) and any other business Segment if applicable within scope of report] Gap Analysis by Region. Country Level Break-up to dig out Trends and emerging opportunity available in area of your business interest. % Market Share & Sales Revenue by Key Players & Local Regional Players . Dedicated Section on Market Entropy to gain insights on Players aggressive Strategies to built market [Merger & Acquisition / Recent Funding & Investment and Key Developments] Patent Analysis** No of patents / Trademark approval filed & received in recent years. Competitive Landscape: Listed Players Company profile with SWOT, In-depth Overview, Product/Services Specification, Headquarter, Subsidiaries, Downstream Buyers and Upstream Suppliers.
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Competitive Landscape:
Mergers & Acquisitions, Agreements & Collaborations, New Product Launches, Business overview & detailed matrix of Product for each player listed in the study. Players exclusively profiled are Regen Biopharma, Global Cord Blood Corporation, CBR Systems, Escape Therapeutics, Cryo-Save, Lonza Group, Pluristem Therapeutics & Stemedica Cell Technology
Most frequently asked question:Why i cant See My company Profiled in the Study?Yes, It might be a possibility that Company you are looking for is not listed, however study is based on vast coverage of players operating inbut due to limited scope and pricing constraints we can only list few random companies keeping a mix of leaders and emerging players. Do contact us if you wish to see any specific company of your interest in the survey. Currently list of companies available in the study are Regen Biopharma, Global Cord Blood Corporation, CBR Systems, Escape Therapeutics, Cryo-Save, Lonza Group, Pluristem Therapeutics & Stemedica Cell Technology
Segment & Regional Analysis: What Market breakdown Would be Covered by geographies, Type & Application/End-users Cell Transplant Market Revenue & Growth Rate by Type [, Peripheral Blood Stem Cells Transplant (PBSCT), Bone Marrow Transplant (BMT) & Cord Blood Transplant (CBT)] (Historical & Forecast) Global Cell Transplant Market Revenue & Growth Rate by Application [Hospitals, Clinics & Others] (Historical & Forecast) Cell Transplant Market Revenue & Growth Rate by Each Region Specified (Historical & Forecast) Cell Transplant Market Volume & Growth Rate by Each Region Specified, Application & Type (Historical & Forecast) Cell Transplant Market Revenue, Volume & Y-O-Y Growth Rate by Players (Base Year)
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To comprehend Global Cell Transplant market dynamics in the world mainly, the worldwide Cell Transplant market is analyzed across major global regions. HTF also provides customized regional and country-level reports
North America: United States, Canada, and Mexico. South & Central America: Argentina, Chile, Colombia and Brazil. Middle East & Africa: Saudi Arabia, United Arab Emirates, Israel, Turkey, Egypt, Tunisia and South Africa. Europe: United Kingdom, France, Poland, Italy, Germany, Spain, NORDIC {Sweden, Norway, Finland, Denmark etc}, BENELUX {Belgium, The Netherlands, Luxembourg },and Russia. Asia-Pacific: SAARC Nations, China, Japan, South Korea, Southeast Asia, New Zealand & Australia.
Actual Numbers & In-Depth Analysis with emerging trends of Cell Transplant Market Size Estimation Available in Full Copy of Report.
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Thanks for reading this article, you can also get individual chapter or section or regional study by limiting the scope to just G7 or G20 or European Union Countries, Eastern Europe, East Asia or Southeast Asia.
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April 22nd, 2020
Diabetes reversed in mice with genetically edited stem cells derived from patients – Washington University School of Medicine in St. Louis
By daniellenierenberg
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CRISPR corrects genetic defect so cells can normalize blood sugar
Researchers at Washington University School of Medicine in St. Louis have transformed stem cells into insulin-producing cells. They used the CRISPR gene-editing tool to correct a defect that caused a form of diabetes, and implanted the cells into mice to reverse diabetes in the animals. Shown is a microscopic image of insulin-secreting beta cells (insulin is green) that were made from stem cells produced from the skin of a patient with Wolfram syndrome.
Using induced pluripotent stem cells produced from the skin of a patient with a rare, genetic form of insulin-dependent diabetes called Wolfram syndrome, researchers transformed the human stem cells into insulin-producing cells and used the gene-editing tool CRISPR-Cas9 to correct a genetic defect that had caused the syndrome. They then implanted the cells into lab mice and cured the unrelenting diabetes in those mice.
The findings, from researchers at Washington University School of Medicine in St. Louis, suggest the CRISPR-Cas9 technique may hold promise as a treatment for diabetes, particularly the forms caused by a single gene mutation, and it also may be useful one day in some patients with the more common forms of diabetes, such as type 1 and type 2.
The study is published online April 22 in the journal Science Translational Medicine.
Patients with Wolfram syndrome develop diabetes during childhood or adolescence and quickly require insulin-replacement therapy, requiring insulin injections multiple times each day. Most go on to develop problems with vision and balance, as well as other issues, and in many patients, the syndrome contributes to an early death.
This is the first time CRISPR has been used to fix a patients diabetes-causing genetic defect and successfully reverse diabetes, said co-senior investigator Jeffrey R. Millman, PhD, an assistant professor of medicine and of biomedical engineering at Washington University. For this study, we used cells from a patient with Wolfram syndrome because, conceptually, we knew it would be easier to correct a defect caused by a single gene. But we see this as a stepping stone toward applying gene therapy to a broader population of patients with diabetes.
Wolfram syndrome is caused by mutations to a single gene, providing the researchers an opportunity to determine whether combining stem cell technology with CRISPR to correct the genetic error also might correct the diabetes caused by the mutation.
A few years ago, Millman and his colleagues discovered how to convert human stem cells into pancreatic beta cells. When such cells encounter blood sugar, they secrete insulin. Recently, those same researchers developed a new technique to more efficiently convert human stem cells into beta cells that are considerably better at controlling blood sugar.
In this study, they took the additional steps of deriving these cells from patients and using the CRISPR-Cas9 gene-editing tool on those cells to correct a mutation to the gene that causes Wolfram syndrome (WFS1). Then, the researchers compared the gene-edited cells to insulin-secreting beta cells from the same batch of stem cells that had not undergone editing with CRISPR.
In the test tube and in mice with a severe form of diabetes, the newly grown beta cells that were edited with CRISPR more efficiently secreted insulin in response to glucose. Diabetes disappeared quickly in mice with the CRISPR-edited cells implanted beneath the skin, and the animals blood sugar levels remained in normal range for the entire six months they were monitored. Animals receiving unedited beta cells remained diabetic. Their newly implanted beta cells could produce insulin, just not enough to reverse their diabetes.
We basically were able to use these cells to cure the problem, making normal beta cells by correcting this mutation, said co-senior investigator Fumihiko Urano, MD, PhD, the Samuel E. Schechter Professor of Medicine and a professor of pathology and immunology. Its a proof of concept demonstrating that correcting gene defects that cause or contribute to diabetes in this case, in the Wolfram syndrome gene we can make beta cells that more effectively control blood sugar. Its also possible that by correcting the genetic defects in these cells, we may correct other problems Wolfram syndrome patients experience, such as visual impairment and neurodegeneration.
In the future, using CRISPR to correct certain mutations in beta cells may help patients whose diabetes is the result of multiple genetic and environmental factors, such as type 1, caused by an autoimmune process that destroys beta cells, and type 2, which is closely linked to obesity and a systemic process called insulin resistance.
Were excited about the fact that we were able to combine these two technologies growing beta cells from induced pluripotent stem cells and using CRISPR to correct genetic defects, Millman said. In fact, we found that corrected beta cells were indistinguishable from beta cells made from the stem cells of healthy people without diabetes.
Moving forward, the process of making beta cells from stem cells should get easier, the researchers said. For example, the scientists have developed less intrusive methods, making induced pluripotent stem cells from blood and they are working on developing stem cells from urine samples.
In the future, Urano said, we may be able to take a few milliliters of urine from a patient, make stem cells that we then can grow into beta cells, correct mutations in those cells with CRISPR, transplant them back into the patient, and cure their diabetes in our clinic. Genetic testing in patients with diabetes will guide us to identify genes that should be corrected, which will lead to a personalized regenerative gene therapy.
Maxwell KG, Augsornworawat P, Velazco-Cruz L, Kim MH, Asada R, Hogrebe NJ, Morikawa S, Urano F, Millman JR. Gene-edited human stem cell-derived cells from a patient with monogenic diabetes reverse pre-existing diabetes in mice. Science Translational Medicine, published online April 22, 2020.
This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of General Medical Sciences, the National Cancer Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH). Grant numbers R01 DK114233, DK112921, TR002065, TR002345, T32 DK108742, R25 GM103757, T32 DK007120, P30 DK020579, P30 CA91842, UL1 TR000448 and UL1 TR002345. Additional assistance was provided by the Washington University Genome Engineering and iPSC Center, the Washington University Diabetes Center, and the Washington University Institute of Clnical and Translational Science, with additional funding from the JDRF, the Washington University Center of Regenerative Medicine, startup funds from the Washington University School of Medicine Department of Medicine, the Unravel Wolfram Syndrome Fund, Silberman Fund, Stowe Fund, Ellie White Foundation for Rare Genetic Disorders, Eye Hope Foundation, Snow Foundation, Feiock Fund, Childrens Discovery Institute, Manpei Suzuki Diabetes Foundation, and a JSPS Overseas Research Fellowship.
Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.
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April 22nd, 2020
12 Top-Rated BB Creams That Can Simplify Your Beauty Routine and Protect Skin, Too – POPSUGAR
By daniellenierenberg
Whether you're still completing a lengthy beauty routine each morning or your beloved products are collecting dust, there's one base makeup item that both can simplify things and persuade the fresh-faced crew to change their tune: BB cream. First developed in South Korea, this all-in-one product can replace your foundation and also your serum, moisturizer, primer, and sometimes even sunblock saving you time, money, and effort.
"Beauty balms" (i.e., "BB") are typically more sheer than traditional foundations (and even most tinted moisturizers), and are easy to apply with a brush, sponge, or even your fingers. Nearly all formulas include some form of SPF to protect against the sun, as well as active ingredients to help treat common skin concerns. Now, this versatility could explain why they seem to be flying off the (virtual) shelves at Sephora, but we picked out 12 popular options that get an A+ from us and other shoppers, too.
Here are the top-rated BB creams you can still nab at Sephora ahead.
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April 22nd, 2020
Demand for Spinal Cord Trauma Treatment Market to Increase from End-use Industries During COVID-19 Pandemic and Substantially Surge Revenues in the…
By daniellenierenberg
Spinal Cord Trauma Treatment Market: Global Industry Analysis 2012 2016 and Forecast 2017 2025is the recent report of Persistence Market Research that throws light on the overall market scenario during the period of eight years, i.e. 2017-2025. According to this report, Globalspinal cord trauma treatment marketis expected to witness significant growth during the forecast period.
This growth is expected to be primarily driven by increasing incidence of spinal cord trauma, and increasing government support to reduce the burden of spinal cord injuries. Additionally, development of nerve cells growth therapy is expected to boost the market in near future.
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The global market for spinal cord trauma treatment is is estimated to be valued at US$ 2,276.3 Mn in terms of value by the end of 2017. The global spinal cord trauma treatment market is expected to expand at a CAGR of 3.7% over the forecast period to reach a value of US$ 3,036.2 Mn by 2025end.
Global Spinal Cord Trauma Treatment Market: Trends
Global Spinal Cord Trauma Treatment Market: Forecast by End User
On the basis of end user, the global spinal cord trauma treatment market is segmented into hospitals and trauma centers. Hospitals segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period.
Hospitals and trauma centers segments are expected to approximately similar attractive index. Hospitals segment accounted for 53.2% value share in 2017 and is projected to account for 52.5% share by 2025 end.
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Global Spinal Cord Trauma Treatment Market: Forecast by Injury Type
On the basis of injury type, the global spinal cord trauma treatment market is segmented into complete spinal cord injuries and partial spinal cord injuries.
Partial spinal cord trauma treatment segment is expected to show better growth than the completed spinal cord treatment segment due to higher growth in the incidence rate of partial spinal cord trauma than the complete spinal cord trauma. With US$ 1,870.3 Mn market value in 2025, this segment is likely to expand at CAGR 3.8% throughout the projected period.
Global Spinal Cord Trauma Treatment Market: Forecast by Treatment Type
On the basis of treatment type, the global spinal cord trauma treatment market is segmented into corticosteroid, surgery, and spinal traction segments.
Surgery segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period. Surgery segment is the most attractive segment, with attractiveness index of 2.6 over the forecast period.
Global Spinal Cord Trauma Treatment Market: Forecast by Region
This market is segmented into five regions such as North America, Latin America, Europe, APAC and MEA. Asia-Pacific account for the largest market share in the global spinal cord trauma treatment market.
Large patient population due to the high rate of road accidents and crime is making the Asia Pacific region most attractive market for spinal cord trauma treatment. On the other hand, MEA and Latin America is expected to be the least attractive market for spinal cord trauma treatment, with attractiveness index of 0.3 and 0.5 respectively over the forecast period.
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April 22nd, 2020
Evotec Regains Global Rights to Beta Cell Replacement Therapy – Yahoo Finance
By daniellenierenberg
HAMBURG, GERMANY / ACCESSWIRE / April 22, 2020 / Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that it will regain global development and commercialisation rights to the iPSC-based programme for the treatment of diabetes developed under collaboration agreement with Sanofi.
Evotec has built a unique platform for iPSC-based drug discovery and cell therapy covering the generation of iPS cell lines, up to cell manufacturing of various cell types for drug screening as well as GMP production of clinical material for cell therapies. Evotec produces human beta cells in islet-like clusters from a GMP-compliant iPS cell line in a scalable bioreactor format, with extensive quality control ("QC") procedures. The beta cell programme has already achieved pre-clinical data demonstrating that they are functionally equivalent to primary human islets in their ability to normalise blood glucose levels in in vivo models over several months.
Evotec will continue the development of the beta cell programme on its own within its EVT Innovate initiative "QRbeta Therapeutics". In parallel, Evotec will explore the best strategic options for further long-term development and commercialisation. An off-the-shelf beta cell therapy product has the potential to revolutionise the treatment of insulin-dependent diabetic patients and therefore could represent a major therapeutic opportunity.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Evotec and Sanofi have developed the beta cell replacement therapy programme since 2015 in a highly productive partnership. During this time, we have made tremendous progress towards bringing a potentially game-changing treatment option to the clinic. We would like to thank Sanofi for the collaboration and its contributions. Regaining full control of this innovative and promising programme to treat diabetes is of great value for Evotec. While we are continuing to move this programme forward, we are exploring partnering options to bring this therapy to patients."
About DiabetesDiabetes mellitus ("diabetes") is a chronic incapacitating disease associated with severe lifelong conditions which require intensive monitoring and control, such as cardiovascular diseases, kidney diseases, nerve damage and eye diseases. At present, there is no cure for diabetes and only symptomatic treatment options are available. According to the International Diabetes Federation, it is estimated that 463 million people worldwide suffered from diabetes in 2019 (2017:425 million) and this number is projected to reach 578 million by 2030. The disease is a major burden to the global healthcare systems with about $ 760 bn being spent on the treatment of diabetes in 2019 and it is projected that expenditure will reach $ 825 bn by 2030.
About Beta CellsBeta cells play a key role in the pathogenesis of diabetes. Beta cells reside in clusters of hormone producing cells ("islets") within the pancreas. They respond to elevated blood glucose levels (e.g. after a meal) by secreting the glucose lowering hormone insulin. In the type 1 form of diabetes ("T1D"), beta cells are destroyed by the patient's own immune system. As a result, T1D patients must follow a life-long regimen of carefully dosed insulin injections. In patients with type 2 diabetes ("T2D"), beta cells are functionally impaired and yet have to work in the presence of metabolic stress and increased workload due to an impaired tissue insulin response. T2D is progressive, and current therapeutic options cannot prevent the deterioration of beta cell function, eventually also creating a need for insulin injections. Despite the fact that insulin treatments are important and widely used for people with diabetes, they cannot fully mimic the normal control of blood glucose levels by normal beta cells necessary to avoid acute and long-term complications of diabetes. There is a critical medical need for novel therapeutic options which can restore beta cell mass and, thereby, reduce or eliminate the need for insulin injections. Furthermore, beta cell replacement therapy also has the potential to prevent or reverse the decline in beta cell function in type 2 diabetes.
ABOUT EVOTEC SEEvotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,000 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women's health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to http://www.evotec.com and follow us on Twitter @Evotec.
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FORWARD LOOKING STATEMENTSInformation set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.
Contact Evotec SE:Gabriele Hansen, SVP Corporate Communications, Marketing & Investor Relations, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com
SOURCE: Evotec AG via EQS Newswire
View source version on accesswire.com: https://www.accesswire.com/586314/Evotec-Regains-Global-Rights-to-Beta-Cell-Replacement-Therapy
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April 22nd, 2020
‘Stem cell therapy more effective on Covid-19’ – Korea Biomedical Review – Korea Biomedical Review
By daniellenierenberg
I dont know why people pay attention only to vaccines and treatments against the new coronavirus. Stem cell therapies are more useful to treat Covid-19.
So claimed Lee Hee-young, president of the Korean Association of Stemcell Therapy, at a news conference in Seoul, Monday. He called for active use of stem cell therapies to treat Covid-19 patients.
Several studies have proved the effects of autologous stem cells in treating acute respiratory distress syndrome (ARDS), which is the leading cause of death in Covid-19 patients, Lee said. The concept of stem cell therapy is the same as that of blood transfusion or bone marrow transplantation. Decades of cell therapies have proved that stem cell therapy is safe.
While the development of a treatment or a vaccine against Covid-19 takes a long time and it may not be able to treat patients immediately because of virus mutation possibilities, stem cell therapies can restore damaged lungs directly, Lee claimed.
It is more important to restore damaged lungs than to fight the virus. Stem cell therapy restores the lungs, giving patients time to beat the virus, he went on to say. However, people are paying attention to vaccine or treatment candidates only. This is why I am holding a news conference.
Lee pointed out that the local environment makes it difficult to use stem cell therapies. Thus, the government should ease regulations on the management and use of cell culture facilities so that doctors can perform stem cell therapies with simple cell culture, he said.
As long as physicians have a positive pressure facility and a culture kit, they can separate and culture cells with simple training, he said. If the authorities allow doctors to perform stem cell therapies with a disposable mobile culture autonomously, the cost of stem cell therapies will go down significantly.
Lee added that he asked related officials to include such rules in the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, which is to take effect in the second half of the year.
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April 21st, 2020
Where To Find Anadrol 50 (Oxymetholone) for Sale – FeastMagazine
By daniellenierenberg
The word steroids are always accompanied by negative comments and inquisitive looks. People have been wary because of its involvement in many controversies and issues throughout the years; and almost always, it involves the sports industry.
As we enter the 21st century, the abuse of anabolic steroids not only escalated, it also became prevalent outside the sports profession. It spread from bodybuilders and fitness instructors to image-conscious teenagers (read more). The youngest to be apprehended was a bunch of 8th graders, ages 15 to 17.
Many are familiar with its potential for misuse, but most are unaware of its medical use in treating several conditions. Anabolic steroids have been the savior of many patients. It helped relieve the symptoms of chronic diseases such as AIDS, myelofibrosis, and lupus. It aided patients suffering from muscle wasting like those undergoing chemotherapy and dialysis.
The appearance and performance-enhancing drug (APED) has many forms and derivatives. One of them is called oxymetholone.
What is oxymetholone?
Oxymetholone is an alkylated synthetic derivative of testosterone. It is one of the few steroids that earned the FDAs approval to be labeled as a prescribed drug, instead of a controlled substance. It is primarily used to treat muscle wasting and several kinds of anemia such as chemo-induced and aplastic anemia.
Like most steroids, oxymetholone has an anabolic-androgenic effect on the human body. The drug is available in the market with the trade names Anadrol 50 and Anapolon. You can only buy Anadrol by getting a medical prescription from your doctor or pharmacist.
How does it work?
Oxymetholones mechanism of action is unlike most anabolic steroids. Once orally ingested, it activates the androgen receptor-mediated signaling in our brain. This binding will start the stimulation of red blood cell production and protein synthesis. This will then promote hemoglobin production and formation of other blood cells. It will also increase the bodys bone density.
Oxymetholone does not bind well to the muscle cells receptor sites. This explains why muscle building and enhancement is only a secondary effect of the drug. But it still brings out the synthetic hormones androgenic effects like increased libido, muscle mass, hirsutism, and voice maturation.
What are its medical uses?
Before the discovery of immunosuppressive drugs, oxymetholone has been at the frontline of managing several chronic anemia cases. Some of its therapeutic benefits are as follows:
Aplastic anemia is a rare and chronic blood disorder that occurs due to stem cell damage inside the bone marrow. This prevents your bone marrow from producing the normal amount of blood cells to sustain your bodys needs. It is characterized as an autoimmune disorder, which means that your own body is producing antibodies to attack and destroy your own bone marrow.
Without treatment, patients will suffer from developing arrhythmia and eventually die from heart failure. Treatments that exist only suppresses the immune system to prevent further production of antibodies. Blood transfusion and the use of oxymetholone are also used to manage aplastic anemia.
The anabolic drug improved the patients hematopoietic development. It increases their RBC production as well as the number of reticulocytes inside the bone marrow.
Another case of blood disorder is the antithrombin deficiency. It is characterized by the production of abnormal blood clots, specifically in the deep veins of the legs.
Clotting should only happen if there is an injury or trauma in the blood vessels. Clots form a stopper-like device inside our body to prevent blood from exiting its vessels. The protein called anti-thrombin prevents our body from forming unnecessary and excessive clots during an injury.
Without it or at low levels, our body would not have a stop signal during clot formation. Thus, creating excessive clots throughout the body that can block the normal blood circulation.
Oxymetholone, in combination with warfarin, is used as a thrombolytic therapy for patients with ATIII deficiency. It augments the bodys fibrinolytic activity and anticoagulant properties.
Hereditary angioedema is a genetic disease characterized by severe swelling in the face, limbs, gastrointestinal tract, and airways. It is a fatal disease due to its common symptom of laryngeal edema. This edema involves the formation of airway and intestinal obstruction that disrupts the normal air delivery to the lungs.
Angioedema is caused by C1 inhibitor deficiency. This protein is found and produced in the bloods plasma or serum. With the use of oxymetholone therapy, a significant increase in the plasma levels of C1 inhibitors is observed. It also improves the level of C4 protein and prevents it from dropping to below normal levels.
The drug is administered to patients in an alternate-day manner. Managing the drug administration prevents side effects like mild virilization and insomnia from occurring.
Chronic weight loss is prevalent in patients undergoing antiretroviral therapy. It can be the medications side effect or from different metabolism alterations. The involuntary loss of weight makes HIV-infected individuals susceptible to opportunistic infections.
To combat this, doctors administered oxymetholone with the antagonist ketotifen to promote weight gain. However, oxymetholone therapy alone showed a much higher increase in the restoration of fat-free muscle mass. Improvements are faster together with proper food intake and mild exercise.
What are its side effects?
Like all medications, the long-term use and abuse of oxymetholone have severe consequences to the body. Fatal ones include the formation of blood-filled cysts or tumors in the liver and spleen. Some long-term aid effects also include:
Allergic reactions such as hives, face swelling, and breathing difficulties may occur during short-term use.
Individuals diagnosed with diabetes, kidney and liver disease, breast and prostate cancer, and cardiovascular diseases may suffer severe conditions if administered with anabolic steroids.
According to the law, oxymetholone must be used under strict medical supervision. Prescription labels should be followed, and dosages may only be changed by your doctor. Skipping or abruptly stopping the medication without consent is highly prohibited.
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April 21st, 2020
First COVID-19 patient in Texas enrolled in UTHealth stem cell therapy study at Memorial Hermann – Community Impact Newspaper
By daniellenierenberg
The first COVID-19 patient in Texas has been enrolled in a stem cell therapy clinical trial designed to combat acute respiratory distress syndrome. (Courtesy Pexels)
The patient received the stem cell procedure April 16 at Memorial Hermann-Texas Medical Center, according to a news release from UTHealth. The patient joins 120 total patients as part of the study, in which participants are randomized to receive either allogeneic, bone marrow-derived mesenchymal stromal cells or a placebo.
Patients with ARDS from COVID-19 have a mortality rate up to 60%, said Dr. Bela Patel, co-principal investigator and director of the Division of Critical Care at McGovern Medical School. Since stem cell therapy may modulate the hyperinflammatory response to SARS-CoV-2, which causes COVID-19, this important study represents a promising potential therapy to improving outcomes in ARDS patients including those with COVID-19 ARDS.
ARDS occurs when the lungs cannot supply the oxygen needed for organs throughout the body, caused by fluid building up in the lungs, according to the news release. Patients with COVID-19 who have developed ARDS need to be placed on a ventilator.
Preclinical trials have shown that hMSCs can help regulate the immune response, which lowers inflammation and reduces the severity of organ injury.
For the UTHealth arm of the study, the hMSCs are being processed at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory at McGovern Medical School.
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April 21st, 2020
Study on Autologous Stem Cell Based Therapies Market (impact of COVID-19) 2020-2026 Brainstorm Cell Therapeutics, Tigenix, Med cell Europe – Bandera…
By daniellenierenberg
Detailed market survey on the Global Autologous Stem Cell Based Therapies Market Research Report 2020-2026. It analyses the vital factors of the Autologous Stem Cell Based Therapies market supported present business Strategy, Autologous Stem Cell Based Therapies market demands, business methods utilised by Autologous Stem Cell Based Therapies market players and therefore the future prospects from numerous angles well. Business associatealysis could be a market assessment tool utilized by business and analysts to grasp the quality of an business. Autologous Stem Cell Based Therapies Market report It helps them get a sense of what is happening in an industry, i.e., demand-supply statistics, Autologous Stem Cell Based Therapies Market degree of competition within the industry, Autologous Stem Cell Based Therapies Market competition of the business with different rising industries, future prospects of the business.
NOTE: Our reports include the analysis of the impact of COVID-19 on this industry. Our new sample is updated which correspond in new report showing impact of Covid-19 on Industry trends. Also we are offering 20% discount
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The Global Autologous Stem Cell Based Therapies market worth about xx billion USD in 2020 and it is expected to reach xx billion USD in 2026 with an average growth rate of x%. United States is the largest production of Autologous Stem Cell Based Therapies Market and consumption region in the world, Europe also play important roles in global Autologous Stem Cell Based Therapies market while China is fastest growing region.
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Leading companies reviewed in the Autologous Stem Cell Based Therapies report are:
RegeneusMesoblastPluristem Therapeutics IncU.S. STEM CELL, INC.Brainstorm Cell TherapeuticsTigenixMed cell Europe
Autologous Stem Cell Based Therapies Market Product Type Segmentation As Provided Below:The Autologous Stem Cell Based Therapies Market report is segmented into following categories:
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The application of product in terms of USD value is represented in numerical and graphical format for all the major regional markets.The Autologous Stem Cell Based Therapies market report is segmented into Type by following categories;Embryonic Stem CellResident Cardiac Stem CellsUmbilical Cord Blood Stem Cells
The Autologous Stem Cell Based Therapies market report is segmented into Application by following categories;Neurodegenerative DisordersAutoimmune DiseasesCardiovascular Diseases
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Industry analysis, for an entrepreneur or a company, is a method that helps it to understand its position relative to other participants in the Autologous Stem Cell Based Therapies Market. It helps them to identify both the opportunities and threats coming their way and gives them a strong idea of the present and future scenario of the Autologous Stem Cell Based Therapies industry. The key to extant during this changing business setting is to know the variations between yourself and your competitors within the Autologous Stem Cell Based Therapies Market. The deep research study of Autologous Stem Cell Based Therapies market based on development opportunities, growth limiting factors and feasibility of investment will forecast the Autologous Stem Cell Based Therapies market growth.
Finally, The global research document on the Autologous Stem Cell Based Therapies Market discovers a large set of information regarding the competitive business environment and other substantial components. The prime aim of these major competitors is to focus on improved technologies and newer innovations.
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April 21st, 2020