Clinical trial to find effective Covid-19 treatments gets underway – Nursing Times

The first patients have now been recruited for a new UK clinical trial of potential drug treatments for Covid-19.

There are currently no specific treatments for the virus but researchers from the University of Oxford will explore whether any existing medications are effective.

There is an urgent need for reliable evidence on the best care for patients with Covid-19"

Peter Horby

In the first instance, the Randomised Evaluation of Covid-19 Therapy (RECOVERY) trial will look at lopinavir-ritonavir, normally used to treat HIV, and the steroid dexamethasone, which is used in a wide range of conditions to reduce inflammation.

The drugs were recommended for inclusion by an expert panel that advises the chief medical officer in England and in the future it is anticipated that the trial will be expanded to assess the impact of other potential treatments.

The chance to join the trial will be offered to adult inpatients who have tested positive for Covid-19 in NHS hospitals and who have not been excluded for medical reasons.

All participants will receive the usual standard of care and will also be chosen at random to receive one of the two drugs being studied or no additional medication.

This will enable researchers to see whether any of the possible new treatments are more or less effective than those currently used for patients with the new strain of coronavirus.

In this way we can rapidly assess the value of potential treatments for Covid-19"

Martin Landray

Peter Horby, professor of emerging infectious diseases and global health in the Nuffield Department of Medicine, University of Oxford, is chief Investigator for the trial.

He said: There is an urgent need for reliable evidence on the best care for patients with Covid-19.

Providing possible new treatments through a well-designed clinical trial is the best way to get that evidence.

Deputy chief investigator Martin Landray, professor of medicine and epidemiology at the Nuffield Department of Population Health, University of Oxford, added: The streamlined design of this clinical trial allows consenting patients to be enrolled in large numbers easily and without compromising patient safety or adding significantly to the workload of busy hospitals and their staff.

In this way we can rapidly assess the value of potential treatments for Covid-19 and provide reliable information on the best ways to treat patients with this disease.

English chief medical officer Chris Whitty and NHS England medical director Stephen Powis have written to NHS trusts in England asking them to fully support the new trial.

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Clinical trial to find effective Covid-19 treatments gets underway - Nursing Times

Pipeline: Investigational Therapies for COVID-19 – The Cardiology Advisor

While no specific treatment for coronavirus disease 2019 (COVID-19) is currently available, several therapies are being investigated globally.*

Antivirals

AbbVie: the Company is collaborating with select health authorities and institutions to determine the antiviral activity of lopinavir/ritonavir (Kaletra) against COVID-19.

AIM ImmunoTech: developing Ampligen, a broad-spectrum antiviral that will be tested as a potential treatment for COVID-19 in Japan. A significant survival effect was observed in a trial evaluating mice infected with the earlier Severe Acute Respiratory Syndrome (SARS) coronavirus.

Gilead: developing remdesivir, a broad-spectrum antiviral agent that is being investigated in a double-blinded, placebo-controlled study sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). In addition, Gilead is initiating two phase 3 trials to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19, following a rapid review and acceptance by the Food and Drug Administration (FDA) of the investigational new drug filing for the novel antiviral.

XORTX Therapeutics: exploring the use of a new formulation of oxypurinol as a novel treatment for acute kidney and lung injury accompanying COVID-19 infection.

Immunotherapies and Other Investigational Therapies

Algernon Pharmaceuticals: developing ifenprodil, an N-methyl-d-aspartate (NDMA) receptor glutamate receptor antagonist, which is being prepared for US clinical trials for COVID-19 based on results of an animal study that showed the investigational therapy significantly reduced acute lung injury and improved survivability in H5N1 infected mice.

CEL-SCI: developing an immunotherapy using LEAPS, a patented T cell modulation peptide epitope delivery technology, to stimulate protective cell-mediated T cell responses and reduce viral load.

Innovation Pharmaceuticals: developing brilacidin, a defensin-mimetic, that mimics the human innate immune system and causes disruption of the membrane of pathogens, leading to cell death. It has already been tested in humans in phase 2 trials for other indications.

Mesoblast Limited: investigating remestemcel-L, an allogeneic mesenchymal stem cell (MSC) product candidate, as a treatment for patients with acute respiratory distress syndrome caused by COVID-19. Remestemcel-L, which is comprised of culture-expanded MSCs derived from the bone marrow of an unrelated donor, is administered in a series of intravenous infusions and is believed to have immunomodulatory properties to counteract inflammatory processes.

Q BioMed: partnering with Mannin Research to develop a potential treatment that addresses vascular leakage and endothelial dysfunction, which may potentially help patients with severe cases of COVID-19.

Regeneron: developing a novel multi-antibody cocktail therapy that can be administered as prophylaxis before exposure to SARS-CoV-2 virus or as treatment for those already infected; may potentially enter human trials by early summer.

Regeneron and Sanofi: clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19 infection. Sarilumab is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. First part of the trial will evaluate the impact of Kevzara on fever and patients need for supplemental oxygen, while the second part will evaluate improvement in longer-term outcomes (ie, preventing death, reducing need for mechanical ventilation, supplemental oxygen and/or hospitalization.

Relief Therapeutics: investigating aviptadil (RLF-100), a vasoactive intestinal polypeptide, for the treatment of acute respiratory distress syndrome in patients with COVI-19 infection. In animal models, aviptadil has been found to have potent anti-inflammatory and anti-cytokine activity in the lungs.

Takeda: developing an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with COVID-19 (TAK-888). Pathogen-specific antibodies from plasma will be collected from recovered patients (or vaccinated donors in the future) and will be transferred to sick patients to improve the immune response to the infection and increase the chance of recovery.

Tiziana: developing TZLS-501, which has been shown to rapidly deplete circulating levels of interleukin-6 (IL-6) in the blood, a key driver of chronic inflammation. Excessive production of IL-6 is believed to be associated with severe lung damage observed with COVID-19 infections.

Vaccines

Altimmune Inc: developing a single-dose, intranasal vaccine against COVID-19 using its proprietary NasoVAX technology. The vaccine is moving toward animal testing.

Applied DNA Sciences: collaborating with Takis Biotech to develop a DNA vaccine candidate using PCR-based DNA (LinearDNA) manufacturing systems; preclinical testing in animals are expected to begin in the second quarter of 2020.

Codagenix Inc: co-developing a live-attenuated vaccine with the Serum Institute of India using viral deoptimization.

GlaxoSmithKline: collaborating with Clover Biopharmaceuticals to develop a protein-based coronavirus vaccine candidate (COVID-19 S-Trimer) using Clovers proprietary technology (Timer-Tag) and combining it with GSKs pandemic adjuvant system.

Inovio Pharmaceuticals: developing a DNA vaccine (INO-4800) to address COVID-19; human trials to begin in the US in April.

Johnson & Johnson: partnering with the Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine using Janssens AdVac and PER.C6 technology, which provide the ability to rapidly upscale production of an optimal vaccine candidate.

Moderna Inc: vials of the Companys mRNA vaccine (mRNA-1273) have been shipped to the National Institute of Allergy and Infectious Diseases to be used in a phase 1 study in the US.

Novavax: currently evaluating multiple recombinant nanoparticle vaccine candidates in animal models; initiation of phase 1 testing is expected in late spring of 2020. The COVID-19 vaccine candidates will likely include the saponin-based Matrix-M adjuvant to enhance immune responses.

Pfizer and BioNTech: co-developing a potential first-in-class COVID-19 mRNA-based vaccine candidate (BNT162), which is expected to enter clinical testing by the end of April 2020.

Sanofi: collaborating with BARDA to develop a vaccine using Sanofis recombinant DNA platform. The DNA sequence encoding the antigen will be combined into the DNA of the baculovirus expression platform and used to produce large quantities of the coronavirus antigen which will be formulated to stimulate the immune system to protect against the virus.

*This list is not all inclusive. Updates will be made as more information becomes available.

This article originally appeared on MPR

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Pipeline: Investigational Therapies for COVID-19 - The Cardiology Advisor

The Global Autologous Cell Therapy Market is expected to grow by USD 1.97 bn during 2020-2024, progressing at a CAGR of 22% during the forecast period…

NEW YORK, March 20, 2020 /PRNewswire/ --

Global Autologous Cell Therapy Market 2020-2024The analyst has been monitoring the global autologous cell therapy market 2020-2024 and it is poised to grow by USD 1.97 bn during 2020-2024, progressing at a CAGR of 22% during the forecast period. Our reports on global autologous cell therapy market 2020-2024 provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors.

Read the full report: https://www.reportlinker.com/p04941084/?utm_source=PRN

The report offers an up-to-date analysis regarding the current global market scenario, latest trends and drivers, and the overall market environment. The market is driven by increasing demand for effective drugs for cardiac and degenerative disorders. In addition, limitations in traditional organ transplantations fueling demand for stem cell therapies is anticipated to boost the growth of the global autologous cell therapy market 2020-2024 as well.

Market SegmentationThe global autologous cell therapy market 2020-2024 is segmented as below:Therapy: Autologous Stem Cell Therapy

Autologus Cellular Immunotherapies

Application: Oncology

Musculoskeletal Disorders

Dermatology

Geographic Segmentation: North America

APAC

Europe

South America

MEA

Key Trends for global autologous cell therapy market 2020-2024 growthThis study identifies limitations in traditional organ transplantations fueling demand for stem cell therapies as the prime reasons driving the global autologous cell therapy market 2020-2024 growth during the next few years.

Prominent vendors in global autologous cell therapy market 2020-2024We provide a detailed analysis of around 25 vendors operating in the global autologous cell therapy market 2020-2024, including some of the vendors such as Bayer AG, Brainstorm Cell Therapeutics Inc., Daiichi Sankyo Co. Ltd., FUJIFILM Holdings Corp., Holostem Terapie Avanzate Srl, Osiris Therapeutics Inc., Takeda Pharmaceutical Co. Ltd., Teva Pharmaceutical Industries Ltd., Sumitomo Chemical Co. Ltd. and Vericel Corp. .The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors.

Read the full report: https://www.reportlinker.com/p04941084/?utm_source=PRN

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

__________________________Contact Clare: clare@reportlinker.comUS: (339)-368-6001Intl: +1 339-368-6001

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The Global Autologous Cell Therapy Market is expected to grow by USD 1.97 bn during 2020-2024, progressing at a CAGR of 22% during the forecast period...

Mentoring is a gift, asking for help a blessing – The Jewish News of Northern California

When I got off the phone with the national president of Hadassah (the worlds largest Zionist womens organization), who had called to invite me to serve on the board of this amazing nonprofit, I was filled with a sense of resolve, renewal and responsibility.

I was also a bit overwhelmed.

Of course, I knew about the work of Hadassah the creation of two hospitals in Jerusalem that were known as bridges to peace in the Middle East and were world-famous for their medical miracles, such as stem-cell treatments that reversed the effects of multiple sclerosis.

I was eager for my first board meeting. Id served on other boards and I thought I was experienced enough for my new role, but I quickly realized that to truly be effective and not to feel like deadwood on a board which I detested from my days as a nonprofit director I couldnt go it alone.

It has taken me many years (and many failures) to realize that asking for help is a sign of strength, not of weakness. I wish I could go back in time and convince my younger self this.

Id never had a mentor. Maybe it was because it didnt occur to me in my youthful ignorance that I needed one, but its more likely because, as a professional in a male-dominated field, no one had ever offered or felt particularly approachable.

The corporate culture I was most familiar with was sink or swim, and youd better do it quickly and youd better be tough.

Fortunately for me, by the time I was mature enough to realize I would benefit from a mentor, I was already a dedicated volunteer with my local Hadassah chapter. I was surrounded by smart, compassionate, accomplished women who were typically 20 years my senior. They were not interested in taking me down but in lifting me up.

One of these women, Liz Alpert, was also on the Hadassah national board. Liz is whip-smart, bold, adventurous and, to my delight, lots of fun. Liz is also generous about sharing her time with me.

Because of her decades of Hadassah national leadership, Liz was like my personal encyclopedia of Hadassah. She could fill in the blanks, read between the lines and give me the historical perspective that wasnt possible to glean no matter how thoroughly I would prepare for the board meetings. Sometimes we disagreed on matters, but I always respected her well-reasoned opinion.

Somewhere between meetings and conferences, Liz and I became great friends. We led a fashion, food, wine and design travel tour to Israel, where I depended on Lizs detail-oriented personality more times than I can count. Weve had fun together at Hadassah conferences across the U.S., and I discovered from our walk-and-talks along the beach in Santa Cruz that Liz has more hustle than Ill ever have.

Recently, Liz and I were walking around Lake Merritt in Oakland (well, Liz was walking and I was perpetually hurrying to catch up to her). The lake that morning was like a mirror, particularly tempting as we got to the boathouse.

Lets rent a rowboat, I said. Liz asked if Id rowed before.Yes, I replied, and off we went.

In the middle of the lake after Id lost the oar (yet again), Liz realized that she should have asked me not whether Id done this before, but whether I knew how to row, which I did not. Of course, Liz knew how to row from childhood summer camps.

She spent the rest of the morning patiently coaching me and taught me how to row at least well enough to get back to the dock.

I think the rowboat adventure (or misadventure, depending whom you ask) is a good analogy for our mentor-mentee relationship. I had the passion, but I didnt know what I didnt know. Luckily, Liz was there to teach me how to safely navigate.

Our mentoring relationship is a wonderful mlange of mother-daughter, sisters and friends. Its women supporting and nurturing women with love and wisdom, and it creates a family bond without biology. I have experienced this in one other area of my life, with Sammie.

Sammie Rogers came into my life as a teenager when I became her quasi-foster mother, and over the years we, too, have evolved into this same wonderful mlange. It seems the key to creating this is for both partners to be open and take a leap of faith. Without the competitiveness of a work environment or the invariable drama involved in mother-daughter relationships, something special but unnamed is created.

I can offer to help Sammie navigate lifes challenges without the subtext of the frequent mother-daughter condemnation and hurt feelings. And Sammie offers me love and inclusion that helps fill my heart. Its a wonderful feeling as a mentor to root for your mentee and celebrate in her successes and in the way she confronts lifes challenges and loss and to watch her persevere and thrive.

Mentoring is a celebration of strength of both the mentee and the mentor and of the bond between them.

While I am confident in Sammies strength and perseverance, she is confident in mine. And we rely on each other.

I brought Sammie to Israel for a vacation, but she brought me up to the top of Masada to see the sun rise. She led the way, she encouraged me, she stayed with me while I caught my breath. Neither of us could accomplish what we did without the other, and we had fun doing it and such a sense of renewal, resolve and responsibility.

Thats what mentoring brings to both partners.

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Mentoring is a gift, asking for help a blessing - The Jewish News of Northern California

The Forefront of Treating Hair Loss in Women – Yahoo Lifestyle

Hair loss has long been a chief complaint among women, especially as they age. It affects some 30 million women in the United States alone, according to the Cleveland Clinic, and will significantly impact more than 50 percent of women during their lifetime. The most common cause is female-pattern hair loss (FPHL), also known as androgenetic alopecia. It's a chronic and progressive condition that has a genetic component, but it's also caused by factors related to the actions of hormonesovarian cysts, use of high androgen index birth control pills, pregnancy, and menopause, explains Ken L. Williams Jr., D.O., hair restoration specialist, surgeon, founder of Orange County Hair Restoration in Irvine, California.

Other medical conditions are also to blame for hair loss in women, including thyroid disorders, polycystic ovary syndrome, anemia, and chronic illnessand the use of certain medications, many of which treat these conditions, can also lead to hair loss in women. "Certain types of autoimmune disorders result in a slightly different and often less dramatic hair loss problem known as alopecia areata, an inflammatory condition that causes hair to come out in clumps or patches," says Dr. Williams Jr.

Luckily, we've come a long way in terms of treating hair loss. After all, 100 years ago, remedies involved things like snake oil and bat and chicken dung. "In more recent years, clinically tested topical and oral products, such as Minoxidil and Propecia, have become available, as well as procedures like PRP (platelet rich plasma therapy), and hair transplants," shares Anabel Kingsley, consultant trichologist and brand president for Philip Kingsley. She finds a holistic, personalized, multi-pronged approach to be the most effective way to treat any form of hair loss. "Since there is no 'one size fits all,' you want to optimize all possible factors that can affect the hair growth cycle, such as general health, nutrition, and stress levels, as well as the condition of your hair and scalp," she says.

At Philip Kingsley, she treats clients with their Trichotherapy Regime ($215, saksfifthavenue.com), which is specifically formulated for women with fine hair and reduced volume. "It tackles hair loss from all possible angles via the scalp with intensive daily Scalp Drops($89, neimanmarcus.com),a daily Stimulating Scalp Tonic ($28, net-a-porter.com), a thickening protein spray, and targeted masks to optimize the scalp environment," Kinglsey explains. "It also contains carefully formulated nutritional supplements to help give hair support from within."

Related: The Best Shampoos to Support Thinning Hair and Fight Female Hair Loss

Over-the-counter solutions won't work for every person suffering from hair loss, but there are a number of medical interventions that can stimulate hair growthanti-androgen medication, for example, is recommended for clients experiencing prolonged hair loss. "These medications help prevent further hair loss and encourage some hair regrowth from dormant hair follicles," says Dr. Williams Jr. There is also stem cell therapy, which has expanded greatly over the last few years in treating medical disease. "As opposed to embryonic cells, the initial stigma of using stem cells has decreased since the discovery of using bone marrow, fat cells, umbilical cord cells, and even skin cells to extract stem cells," he explains.

Surgery is also an option, and there are currently two primary surgical techniques or methods used in performing hair transplantation: Follicular Unit Transplantation (FUT) and Follicular Unit Extraction (FUE). "With the FUT technique, a section of scalp is excised with a scalpel, the scalp is brought together with sutures or staples and the hair follicles or hair grafts are inserted into tiny slits placed by the surgeon in the balding recipient area," Dr. Williams Jr. says. "The follicles with a single hair are placed in the front rows to define and create a natural hairline and the more dense, natural occurring follicular units are placed by hand in areas where hair density is needed the most."

FUE, a minimally invasive technique that is being hailed as the most significant improvement in hair surgery, uses a minimal depth scoring punch device to loosen the follicle from the surrounding tissues. "With the FUE procedure, a 0.9 or 1.0 millimeter punch minimal depth scoring excision is used in the skin around the upper part of the follicular unit (hair follicles)," he continues. "The hair follicle is then extracted directly from the scalp and manually placed into tiny slits in the balding area similar to the strip method."

There are still several hair restoration solutions left to be discoveredand experts believe most of us will see the concept of hair cloning come to fruition in their lifetime. "Hair cloning would in effect, disassemble a few hair follicles, multiply these cells in the laboratory and then reintroduce them into the scalp to both rejuvenate miniaturizing hair follicles and induce brand new hairs," Dr. Williams Jr. says. "Other groups have tried this but it has been found that when human follicle cells are cultured, they rapidly lose their functionality."

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The Forefront of Treating Hair Loss in Women - Yahoo Lifestyle

Regulatory authorities approve JTA Phase III study in osteoarthritic knee pain and ALLOB Phase IIb study in difficult fractures | DNA RNA and Cells |…

DetailsCategory: DNA RNA and CellsPublished on Monday, 23 March 2020 16:33Hits: 392

GOSSELIES, Belgium I March 23, 2020 I BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces it has received regulatory approvals for its Clinical Trial Applications for the next studies of both of its lead candidates. These two studies are the pivotal JTA-004 PhaseIII clinical study targeting osteoarthritic knee pain and the PhaseIIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. The JTA-004 trial has been approved by regulatory authorities in Denmark, and the ALLOB by Belgian regulatory authorities.

Bone Therapeutics now has completed preparations for these trials. It is ready to initiate recruitment in both of these studies as soon as the current situation regarding COVID-19 allows, in those two countries. Bone Therapeutics has taken this decision to support healthcare systems in the respective trial countries, enabling them to concentrate on treating COVID-19 patients whilst necessary.

Bone Therapeutics is now ready to commence clinical trials on both its lead products. Receiving regulatory approvals for both Clinical Trial Applications completes the preparative activity for both studies, said Miguel Forte, CEO, Bone Therapeutics. This means that as soon as the current situation allows, we will be able to start recruiting patients for both clinical studies and continue to develop options for patients suffering knee osteoarthritic pain and difficult tibial fractures, both of which are conditions with a high unmet medical need.

The JTA-004 phase III study is a controlled, randomized, double-blind study. It will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market. The study expects to enrol 676patients with mild to moderate symptomatic knee osteoarthritis in approximately 20centres in 7European countries and Hong Kong SAR.

The ALLOB Tibial Fracture PhaseIIb study is a randomized, double-blind, controlled study in which the fracture healing potential of ALLOB in patients with difficult fractures in the shinbone (tibia) will be evaluated and compared to standard of care alone after a follow-up period of 6 months. ALLOB will be applied by single percutaneous injection 24-72hours post reduction surgery in patients with fresh tibial fractures at risk for delayed or non-union. The study is expected to enrol approximately 178patients in approximately 40sites in up to 7European countries.

About JTA-004

JTA-004 is companys next generation of intra-articular injectable for the treatment of osteoarthritic pain in the knee. Consisting of a unique mix of plasma proteins, hyaluronic acid, a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain. In a phaseII study involving 164 patients, JTA-004 showed an improved pain relief at 3 and 6 months compared to Hylan G-F20, the global market leader in osteoarthritis treatment.

About Knee Osteoarthritis

Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250M cases worldwide.

The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA lead to highly invasive surgical interventions such as total knee replacement.

About ALLOB and Bone Therapeutics proprietary, scalable cell therapy manufacturing process

ALLOB is the companys off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells. These cells are derived from cultured bone marrow mesenchymal stem cells (MSC) from healthy adult donors. To address critical factors for the development and commercialization of cell therapy products, Bone Therapeutics has established a proprietary, optimized production process that improves the consistency, scalability, cost effectiveness and ease of use of the ALLOB platform. This optimized production process significantly increases the production yield, generating 100,000 of doses per bone marrow donation. Additionally, the final ALLOB product is cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the healthcare site. The process does therefore substantially improve product quality, reduce overall production costs, simplify supply chain logistics, increase patient accessibility and facilitate global commercialization compared to an autologous approach. Bone Therapeutics has implemented the optimized production process to produce clinical batches for the upcoming Phase IIb clinical trial in patients with tibial difficult-to-heal fractures.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering PhaseIII development for the treatment of pain in knee osteoarthritis. Positive PhaseIIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) for the pivotal PhaseIII program has been approved by the Danish relevant authorities allowing the start of the study.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the CTA approval by the Belgian regulatory authority, the Company is ready to start the PhaseIIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

SOURCE: Bone Therapeutics

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Regulatory authorities approve JTA Phase III study in osteoarthritic knee pain and ALLOB Phase IIb study in difficult fractures | DNA RNA and Cells |...

Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients – Associated…

VANCOUVER, Washington, March 23, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the third and fourth coronavirus patients were treated with the Companys investigational new drug, leronlimab. The treatment of the third patient occurred on Friday and the fourth coronavirus patient was treated on Saturday. These patients are under the care of the same leading medical center in the New York City area that treated the first and second patients.

The treatment with leronlimab is being administered under an emergency IND recently granted by the U.S. Food and Drug Administration (FDA). The treatment with leronlimab is intended to serve as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).

Bruce Patterson, M.D., CEO of IncellDx, a diagnostic partner and advisor to CytoDyn, said, IncellDx has developed specific companion diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We believe that leronlimab acts by enhancing the immune response while mitigating the cytokine storm that leads to morbidity and mortality in these patients.

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said, We are encouraged that the onsite medical team is reporting no safety issues and our team continues to be responsive and supportive in any way we can.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain and it is unclear how easily the virus spreads. COVID-19 is thought to be transmitted person to person through respiratory droplets, commonly resulting from coughing, sneezing and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough and shortness of breath. It is believed that symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure, and that symptoms in patients have ranged from non-existent to severe and fatal. At this time, there are very limited treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH. Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additional clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn's Leronlimab, Bringing the Total to Four Patients - Associated...

Platelet Rich Plasma and Stem Cell Alopecia Treatment size in terms of volume and value 2019-2022 – Daily Science

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The global platelet rich plasma & stem cell alopecia treatment market has been segmented as below:

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Platelet Rich Plasma and Stem Cell Alopecia Treatment size in terms of volume and value 2019-2022 - Daily Science

Bone Therapeutics receives Clinical Trial Application (CTA) approval for next clinical studies of its two lead candidates – GlobeNewswire

Regulated information

Regulatory authorities approve JTA PhaseIII study in osteoarthritic knee pain and ALLOB PhaseIIb study in difficult fractures

Gosselies, Belgium, 23March 2020, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces it has received regulatory approvals for its Clinical Trial Applications for the next studies of both of its lead candidates. These two studies are the pivotal JTA-004 PhaseIII clinical study targeting osteoarthritic knee pain and the PhaseIIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. The JTA-004 trial has been approved by regulatory authorities in Denmark, and the ALLOB by Belgian regulatory authorities.

Bone Therapeutics now has completed preparations for these trials. It is ready to initiate recruitment in both of these studies as soon as the current situation regarding COVID-19 allows, in those two countries. Bone Therapeutics has taken this decision to support healthcare systems in the respective trial countries, enabling them to concentrate on treating COVID-19 patients whilst necessary.

Bone Therapeutics is now ready to commence clinical trials on both its lead products. Receiving regulatory approvals for both Clinical Trial Applications completes the preparative activity for both studies, said Miguel Forte, CEO, Bone Therapeutics. This means that as soon as the current situation allows, we will be able to start recruiting patients for both clinical studies and continue to develop options for patients suffering knee osteoarthritic pain and difficult tibial fractures, both of which are conditions with a high unmet medical need.

The JTA-004 phase III study is a controlled, randomized, double-blind study. It will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market. The study expects to enrol 676patients with mild to moderate symptomatic knee osteoarthritis in approximately 20centres in 7European countries and Hong Kong SAR.

The ALLOB Tibial Fracture PhaseIIb study is a randomized, double-blind, controlled study in which the fracture healing potential of ALLOB in patients with difficult fractures in the shinbone (tibia) will be evaluated and compared to standard of care alone after a follow-up period of 6 months. ALLOB will be applied by single percutaneous injection 24-72hours post reduction surgery in patients with fresh tibial fractures at risk for delayed or non-union. The study is expected to enrol approximately 178patients in approximately 40sites in up to 7European countries.

About JTA-004

JTA-004 is companys next generation of intra-articular injectable for the treatment of osteoarthritic pain in the knee. Consisting of a unique mix of plasma proteins, hyaluronic acid, a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain. In a phaseII study involving 164 patients, JTA-004 showed an improved pain relief at 3 and 6 months compared to Hylan G-F20, the global market leader in osteoarthritis treatment.

About Knee Osteoarthritis

Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250M cases worldwide.

The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA lead to highly invasive surgical interventions such as total knee replacement.

About ALLOB and Bone Therapeutics proprietary, scalable cell therapy manufacturing process

ALLOB is the companys off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells. These cells are derived from cultured bone marrow mesenchymal stem cells (MSC) from healthy adult donors. To address critical factors for the development and commercialization of cell therapy products, Bone Therapeutics has established a proprietary, optimized production process that improves the consistency, scalability, cost effectiveness and ease of use of the ALLOB platform. This optimized production process significantly increases the production yield, generating 100,000 of doses per bone marrow donation. Additionally, the final ALLOB product is cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the healthcare site. The process does therefore substantially improve product quality, reduce overall production costs, simplify supply chain logistics, increase patient accessibility and facilitate global commercialization compared to an autologous approach. Bone Therapeutics has implemented the optimized production process to produce clinical batches for the upcoming Phase IIb clinical trial in patients with tibial difficult-to-heal fractures.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering PhaseIII development for the treatment of pain in knee osteoarthritis. Positive PhaseIIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) for the pivotal PhaseIII program has been approved by the Danish relevant authorities allowing the start of the study.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the CTA approval by the Belgian regulatory authority, the Company is ready to start the PhaseIIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

Contacts

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: 44 (0)20 8943 4685neil@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics receives Clinical Trial Application (CTA) approval for next clinical studies of its two lead candidates - GlobeNewswire

Stem Cell Alopecia Treatment Market Booming by Size, Revenue and Top Growing Companies APEX Biologix, Belgravia Center, RepliCel, Riken Research…

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

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

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Stem Cell Alopecia Treatment Market Booming by Size, Revenue and Top Growing Companies APEX Biologix, Belgravia Center, RepliCel, Riken Research...