Stem Cell Therapy Market to 2027 – Global Analysis and Forecasts by Type; Treatment; Application; End User, and Geography – Yahoo Finance

NEW YORK, April 15, 2020 /PRNewswire/ -- The stem cell therapy market was valued at US$ 1,534.55 million in 2019 and is estimated to reach US$ 5,129.66 million by 2027; it is expected to grow at a CAGR of 16.7% from 2020 to 2027.

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The increasing awareness related to the stem cells therapy in effective disease management and growing demand for regenerative medicines are the key factor driving the stem cell therapy market. However, high cost related of the stem cell therapy limits the growth of the market.Stem cell research has been widely investigated globally for various medical applications, especially for the treatment of humans.This raises the importance of creating public awareness about stem cell research and its clinical potential.

The main role of stem cells is in the replacement of dying cells and reconstruction of damaged tissues. Based on the extensive stem cell research, many scientists have claimed that these cells could probably be used in the treatment of various diseases, including cancer and cardiovascular disease.There is a large number of potential treatment procedures that are undergoing clinical trials, and a notably few stem cell therapies have won FDA (i.e., US Food and Drug Administration) approval for clinical usage. For instance, in 2019, the FDA approved Fedratinib for the first-line treatment for myelofibrosis. Moreover, stem cell therapies are widely used in bone marrow transplantation, and these therapies have benefited thousands of people suffering from leukemia. Hematopoietic stem cells are used for treating more than 80 medical diseases, including immune system disorders, blood disorders, neurological disorders, metabolic disorders, genetic disorders, and several types of cancers, such as leukemia and lymphoma; this is also likely to boost the demand for this treatment procedure during the forecast period. Researchers are further investigating the use of stem cell therapies in the treatment of autoimmune disorders.

The global stem cell therapy market has been segmented on the basis of type, treatment, application type, and end user.Based on type, the market has been segmented into adult stem cell therapy, induced pluripotent stem cell therapy, embryonic stem cell therapy, and others.

The adult stem cell therapy held the largest share of the market in 2019; however, induced pluripotent stem cell therapy is estimated to register the highest CAGR in the market during the forecast period.Based on treatment, the stem cell therapy market has been segmented into allogeneic and autologous.

The allogeneic segment held a larger share of the market in 2019; however, the market for the autologous segment is expected to grow at a higher CAGR during the forecast period.Based on application type, the stem cell therapy market has been segmented into musculoskeletal, dermatology, cardiology, drug discovery and development, and other applications.

The musculoskeletal segment held the largest share of the stem cell therapy market in 2019, whereas the drug discovery and development segment is expected to report the highest CAGR during 20202027. Based on end user, the market has been segmented into academic and research institutes, and hospitals and specialty clinics. The academic & research institutes held the largest share of the market in 2019, and it is also expected to report the highest CAGR during the forecast period.Several essential secondary sources referred to for preparing this report are the FDA, World Health Organization (WHO), Organisation for Economic Co-operation and Development, National Institutes of Health, Spanish Agency for Medicines (AEMPS), Japanese Society for Regenerative Medicine, and Indian Council of Medical Research, among others.

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Chronic Health Conditions, Not Transplant Receipt, Linked to Symptom Prevalence in Survivors of Childhood Hematologic Malignancies – Hematology…

Poor patient-reported outcomes insurvivors of childhood hematologic malignancies are associated with thepresence of chronic health conditions, regardless of whether patients had receivedhematopoietic stem cell transplantation (HSCT) or conventional therapy,according to a study published in Blood.

Investigators compared symptomprevalence, health-related quality of life (HRQoL), and risk factors in adultsurvivors. In multivariate logistic regression analyses, these patient-reportedoutcomes were compared with results of surveys and medical assessments given tomembers of a noncancer control group (242 patients). Survivors of hematologicmalignancies were organized by treatment type to either HSCT group (112patients) or conventional treatment group (1106 patients).

Compared with individuals in the noncancer group, survivors who had received HSCT reported substantially higher rates of symptom prevalence across memory (adjusted odds ratio [aOR], 4.8), sensation (aOR, 4.7), pulmonary (aOR, 4.6), and motor/movement domains (aOR, 4.3). Physical HRQoL was also significantly worse for survivors who received HSCT, compared with patients who did not have cancer (aOR, 6.9).

The investigators found nosignificant difference between survivors from each treatment group in terms ofHRQoL and symptom prevalence by domain. Organ-specific chronic healthconditions were a greater indicator of the prevalence of most symptom domainsthan treatment type.

Some ocular symptoms showedhigher cumulative prevalence among those who received HSCT compared withconventional treatment. These related to eye dryness (P <.0001),difficulty seeing while aided by glasses (P <.0001), and doublevision (P =.04).

The goal of cancersurvivorship care is not merely to identify and manage medical complications,but also to improve daily functional status and HRQOL, the investigators wrote.

The researchers also indicatedthat clinicians should consider proactively screening survivors of pediatrichematologic malignancies, particularly those treated with HSCT who have chronichealth conditions, for symptoms phenotypes to aid in the early identificationof adverse events.

Reference

Yen HJ, Eissa H, Bhatt NS, et al. Patient-reported outcomes in survivors of childhood hematologic malignancies with hematopoietic stem cell transplant [published online April 2, 2020]. Blood. doi: 10.1182/blood.2019003858

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Chronic Health Conditions, Not Transplant Receipt, Linked to Symptom Prevalence in Survivors of Childhood Hematologic Malignancies - Hematology...

Researchers restore sight in mice by turning skin cells into light-sensing eye cells – National Institutes of Health

News Release

Wednesday, April 15, 2020

NIH-funded study offers new path to modeling eye disease, advancing therapies

Researchers have discovered a technique for directly reprogramming skin cells into light-sensing rod photoreceptors used for vision. The lab-made rods enabled blind mice to detect light after the cells were transplanted into the animals eyes. The work, funded by the National Eye Institute (NEI), published April 15 in Nature. The NEI is part of the National Institutes of Health.

Up until now, researchers have replaced dying photoreceptors in animal models by creating stem cells from skin or blood cells, programming those stem cells to become photoreceptors, which are then transplanted into the back of the eye. In the new study, scientists show that it is possible to skip the stem-cell intermediary step and directly reprogram skins cells into photoreceptors for transplantation into the retina.

This is the first study to show that direct, chemical reprogramming can produce retinal-like cells, which gives us a new and faster strategy for developing therapies for age-related macular degeneration and other retinal disorders caused by the loss of photoreceptors, said Anand Swaroop, Ph.D., senior investigator in the NEI Neurobiology, Neurodegeneration, and Repair Laboratory, which characterized the reprogrammed rod photoreceptor cells by gene expression analysis.

Of immediate benefit will be the ability to quickly develop disease models so we can study mechanisms of disease. The new strategy will also help us design better cell replacement approaches, he said.

Scientists have studied induced pluripotent stem (iPS) cells with intense interest over the past decade. IPSCs are developed in a lab from adult cells rather than fetal tissue and can be used to make nearly any type of replacement cell or tissue. But iPS cell reprogramming protocols can take six months before cells or tissues are ready for transplantation. By contrast, the direct reprogramming described in the current study coaxed skin cells into functional photoreceptors ready for transplantation in only 10 days. The researchers demonstrated their technique in mouse eyes, using both mouse- and human-derived skin cells.

Our technique goes directly from skin cell to photoreceptor without the need for stem cells in between, said the studys lead investigator, Sai Chavala, M.D., CEO and president of CIRC Therapeutics and the Center for Retina Innovation. Chavala is also director of retina services at KE Eye Centers of Texas and a professor of surgery at Texas Christian University and University of North Texas Health Science Center (UNTHSC) School of Medicine, Fort Worth.

Direct reprogramming involves bathing the skin cells in a cocktail of five small molecule compounds that together chemically mediate the molecular pathways relevant for rod photoreceptor cell fate. The result are rod photoreceptors that mimic native rods in appearance and function.

The researchers performed gene expression profiling, which showed that the genes expressed by the new cells were similar to those expressed by real rod photoreceptors. At the same time, genes relevant to skin cell function had been downregulated.

The researchers transplanted the cells into mice with retinal degeneration and then tested their pupillary reflexes, which is a measure of photoreceptor function after transplantation. Under low-light conditions, constriction of the pupil is dependent on rod photoreceptor function. Within a month of transplantation, six of 14 (43%) animals showed robust pupil constriction under low light compared to none of the untreated controls.

Moreover, treated mice with pupil constriction were significantly more likely to seek out and spend time in dark spaces compared with treated mice with no pupil response and untreated controls. Preference for dark spaces is a behavior that requires vision and reflects the mouses natural tendency to seek out safe, dark locations as opposed to light ones.

Even mice with severely advanced retinal degeneration, with little chance of having living photoreceptors remaining, responded to transplantation. Such findings suggest that the observed improvements were due to the lab-made photoreceptors rather than to an ancillary effect that supported the health of the hosts existing photoreceptors, said the studys first author Biraj Mahato, Ph.D., research scientist, UNTHSC.

Three months after transplantation, immunofluorescence studies confirmed the survival of the lab-made photoreceptors, as well as their synaptic connections to neurons in the inner retina.

Further research is needed to optimize the protocol to increase the number of functional transplanted photoreceptors.

Importantly, the researchers worked out how this direct reprogramming is mediated at the cellular level. These insights will help researchers apply the technique not only to the retina, but to many other cell types, Swaroop said.

If efficiency of this direct conversion can be improved, this may significantly reduce the time it takes to develop a potential cell therapy product or disease model, said Kapil Bharti, Ph.D., senior investigator and head of the Ocular and Stem Cell Translational Research Section at NEI.

Chavala and his colleagues are planning a clinical trial to test the therapy in humans for degenerative retinal diseases, such as retinitis pigmentosa.

The work was supported by grants EY021171, EY025667, EY025905, and EY025717 and NEI Intramural Research Program grants ZIAEY000450, ZIAEY000474 and ZIAEY000546.

The University of North Texas has a patent pending on the chemical reprogramming method reported in this paper. CIRC Therapeutics is a start-up company that plans to commercialize treatments using the technology.

This press release describes a basic research finding. Basic research increases our understanding of human behavior and biology, which is foundational to advancing new and better ways to prevent, diagnose, and treat disease. Science is an unpredictable and incremental process each research advance builds on past discoveries, often in unexpected ways. Most clinical advances would not be possible without the knowledge of fundamental basic research.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Mahato B, Kaya KD , Fan Y, Sumien N, Shetty RA, Zhang W, Davis D, Mock T , Batabyal S, Ni A, Mohanty S, Han Z, Farjo R, Forster M, Swaroop A and Chavala SH. Pharmacologic fibroblast reprogramming into photoreceptors restores vision. Published online April 15, 2020 in Nature.http://dx.doi.org/10.1038/s41586-020-2201-4

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Researchers restore sight in mice by turning skin cells into light-sensing eye cells - National Institutes of Health

Hope that sight could be restored by reprogramming skin cells – inews

NewsHealthA treatment to restore peoples sight by creating retina-like cells and implanting them into eyes could be available within a decade

Wednesday, 15th April 2020, 11:17 pm

A treatment to restore peoples sight by creating retina-like cells and implanting them into eyes could be available within a decade, scientists say.

The technique partially restored the vision of blind mice and researchers will now look to test it on humans.

The process involves taking skin cells from a blind mouse, or human, and reprogramming them into light-sensing photoreceptors used for vision.

Even mice with severely advanced retinal degeneration, with little chance of having living photoreceptors remaining, responded to transplantation, said Biraj Mahato, of the Health Science Centre at the University of North Texas, in Fort Worth.

Potential to restore human sight

This new treatment has the potential to restore vision in patients with retinal photoreceptor loss, said his colleague, Professor Sai Chavala.

Other attempts to replace dying photoreceptors have taken longer and involved creating stem cells from skin or blood cells and reprogramming them to become photoreceptors, which are then transplanted into the back of the eye.

Scientists have found a way to speed up the process by missing out the middle step of stem cell creation and directly reprogramming skins cells to become photoreceptors.

This cuts the amount of time taken to create photoreceptors for implant from six months to two weeks. The team hopes the technique could be used to generate a range of cell types to treat other diseases.

First study of its kind

This is the first study to show that direct, chemical reprogramming can produce retinal-like cells, said Anand Swaroop, of the US National Eye Institute in Bethesda, Maryland.

This gives us a new and faster strategy for developing therapies for age-related macular degeneration and other retinal disorders caused by the loss of photoreceptors.

During the operation, surgeons would pierce the retina and inject cells beneath it, a procedure that has been well performed for the delivery of viruses for gene and cell therapy.

The findings are reported in the scientific journal Nature.

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Hope that sight could be restored by reprogramming skin cells - inews

Stem cell treatment works for many, but insurance doesn’t cover it – msnNOW

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UP NEXT

Still waiting for stem cell treatments to come to a doctor's officenear you?

It seems like a decade or two since we were introduced to stem cell research and treatments,and told that, through them,we might beat the degradation of a dreaded disease, recover from an injury or a degenerated joint, and that all these could be things of the past.

All we'd need to do was get an injection of our own stem cells and like magic we'd be up and running again almost like new.Let the body heal itself.Sounds like a dream.

Well in some circles this is more than a dream: Its happening.

Recently I spoke with Mark Berman, a doctor in Beverly Hills, about his Cell Surgical Network: Amore than decade-old business that's busy advancing medical research by using a network of doctor's following specific stem cell protocols.He networks with over 100 doctors in the U.S. and abroad who are enthusiastic about the potential of stem cells and want to see stem cell treatments become a normal part of health care.

To have a betteridea of the protocol, I visited the office of long-time Redding physician Robert Ghelfi, who is in Berman's network.Ghelfiis the medical director of the Northern California Stem Cell Treatment Center that affiliates with several Redding physicians.

He explained the stem cell extraction method: Takea little fat from the patient and spinit to separate the stem cells. Onceseparated, Ghelfiprepares the patients own stem cells forinjection into the injured, damaged or degenerating site on the patient's body.It seems like a surprisingly simple and straightforward procedure. It typically takes one injection,Ghelfisaid, and the visit lasts about an hour.

UP NEXT

Stem cells are attracted to injured, damaged or ill-performing tissue, Berman and Ghelfi explained.Once injected into the region, they begin to heal and regenerate tissue.

How effective is it?

It depends on the area of the body and the problem.

Both Berman and Ghelfi mentioned the 83% success rate they've had with injecting over 6,000 degenerated knees. This treatment is popular with people who opted not to have a knee replacement surgery.

A complication with younger people getting knee replacements is the need for another replacement years later, since the first can wear out. With stem cell therapy, this problem can be avoided, Ghelfi said.

Research shows success with other conditions as well.

For his part, Ghelfi is impressed by the research,and his own clinical experience,using stem cells for the treatment of chronic obstructive pulmonary disease (COPD).

Under the heading of COPDfalls chronic bronchitis and emphysema. Since chronic bronchitis usually progresses to emphysema, Ghelfis goalis to try to stabilize pulmonary function.

"This is a huge improvement for COPD since the rate of decline annually is fourpercent," he said. And since pulmonary function is easily measurable, it works nicely forresearch data.

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Success has been reported by injecting stem cells into disc protrusions, thumbs, fingers, wrists, elbows, ankles, hips, necks, backs, tendons and for treating non-healing wounds, congestive heart failure, Parkinson's disease, peripheral neuropathy, asthma, multiple sclerosis, lupus and rheumatoid arthritis.

As research continues to be compiled by participating doctors, the body of work into stem cell applications increases.

Berman and Ghelfi are both surgeons who've become interested in stem cell therapies because of the results theyve achieved, their ease of use and lack of side effects.

Stem cell research is still in its relative infancy, and I have no doubt that these pioneers will be moving the needle in healthcare not only in the United States, but worldwide.

Note: This stem cell procedure is not covered by insurance and the cost is between $5,000 and $7,000for treatment, Ghelfi said. If you think you have a health situation that might benefit from stem cell treatment, he offers a free consultation.

Research and treatments have shown promise.More options are always good.

Trudi Pratt has a chiropractic and clinical nutrition practice in Redding.Reach her athttp://www.drtrudipratt.com/ or at 244-7873.

This article originally appeared on Redding Record Searchlight: Stem cell treatment works for many, but insurance doesn't cover it

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Stem cell treatment works for many, but insurance doesn't cover it - msnNOW

Orgenesis Acquiring Tamir, And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha

Orgenesis to Acquire Tamir Biotechnology's Assets for $19 Million

Orgenesis Inc. (ORGS) reported that it has signed a deal with Tamir Biotechnology Inc., under which the former will acquire the assets of the latter, including its broad spectrum antiviral platform ranpirnase. The deal is cash- and stock-based and is expected to be worth nearly $19 million. Orgenesis plans to merge ranpirnase with its co-developed Bioxome technology for improving payload delivery direct to the cells.

Combined with ranpirnase, Bioxomes have showed the ability to fuse with cell membranes and delivering an intracellular cargo, mimicking the working of natural exosomes. Bioxomes, when loaded with predesignated genetic material, proteins, signaling molecules and drugs, copy the natural membrane fusion capacities of exosomes. This feature may help in providing more efficient antiviral results.

TamirBio is a clinical-stage company focusing on developing treatments for viruses and other pathological conditions. Its lead asset, ranpirnase, is a ribonuclease and belongs to a superfamily of enzymes which may catalyze the degradation of RNA. It may also mediate in different essential biological activities, such as the regulation of cell proliferation, differentiation, maturation and death. According to Orgenesis, this feature makes it suitable for treating viral and autoimmune diseases which require therapies with anti-proliferative and apoptotic properties.

TamirBio has used these properties for developing topical ranpirnase for treating human papillomavirus, a leading cause of genital warts. The drug candidate has been evaluated in Phase I/II clinical trial for genital warts, and the results demonstrated clear clinical effects. The company plans to hold additional clinical trials. Orgenesis CEO Vered Caplan said, In independent third-party testing, ranpirnase has shown anti-viral activity in multiple viruses. Additionally, over 1,000 patients have been dosed with ranpirnase in previous cancer/mesothelioma clinical trials. Ranpirnase demonstrated a strong safety and tolerability profile that should help accelerate the approval pathway. TamirBio claims that the drug candidate has shown preclinical antiviral activity in such viral diseases as HPV, HIV, Ebola, and SARS.

Orgenesis also provided updates about its operating activities and reported that its research & development labs are still working. In February, the company sold its subsidiary Masthercell Global Inc. to Catalent Pharma Solutions for nearly $127 million. Masthercell was a contract development manufacturing organization. Orgenesiss CGT Biotech Platform mainly consists of three core components, which are POCare Therapeutics, POCare Technologies, and POCare Network. The CGT Biotech Platform aims to decentralize the CGT supply chain.

The company also recently entered into a new joint venture with Revatis. The partnership will work towards providing autologous cell therapies with exosomes and other cellular products obtained from muscle-derived mesenchymal stem cells. The task of making the stem cells will be entrusted to Revatis, which will use its minimally invasive muscle biopsy technique and isolator technology for this purpose. Orgenesis will be responsible for providing clinical and regulatory expertise and access to its point-of-care (PoC) technology. This POCare platform provides access to a global network of hospitals and research institutes which may be used for carrying out clinical trials for developing life-saving therapies.

Teladoc Health Inc. (TDOC) stock showed solid gains as the ongoing pandemic has put a spotlight on telemedicines. The company has seen a surge in the download of its app BetterHelp, which has a virtual behavioral health offering. According to a research note released by Bank of America Global Research, the app had the download volume of nearly 1000 per day in March, which has now surged to over 1800 per day.

While telemedicine has been around for quite some time, the current scenario has led to mass acceptance of this virtual practice. Due to strict restrictions on movement and the unprecedented burden on healthcare services, telemedicine has proved to be a boon for people with non-critical ailments. Under the 1135 waiver authority and the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, the scope of telehealth facilities has been widened to include coverage for office, hospital and other visits equipped with telehealth facilities in the United States and at patients residences.

The Teladoc platform was recently deployed by Tower Health for offering virtual health care for patients suffering from different ailments. Each visit was provided at $45 and is available 24 hours a day, 7 days a week. Apart from COVID 19, some of the other prominent health issues addressed by the platform are flu symptoms, respiratory infection and rashes. Dr. Lewis Levy, chief medical officer of Teladoc, said, There is no doubt that we are seeing positive momentum and that awareness has increased. Telemedicine is now a household term.

It is estimated that the global telehealth market is expected to register 16.9 percent CAGR during the 2020-2025 forecast period. It will likely be worth $55.6 billion by 2025, up from current valuation of $25.4 billion in 2020. The low-risk and high-efficiency nature of these services are making them very popular now.

Pluristem Therapeutics Inc. (PSTI) reported that it has treated its first patient suffering from complications arising from the novel coronavirus. The patient was treated under the FDA Single Patient Expanded Access Program, and PLX cell therapy was used for this purpose. The company is now looking to initiate a multinational clinical trial at the earliest possible.

Pluristem further said that the patient was in critical condition with respiratory failure due to acute respiratory distress syndrome. The patient was in an intensive care unit with mechanical ventilation for three weeks. Single Patient Expanded Access Program is also known as a compassionate use program and is a part of the US Coronavirus Treatment Acceleration Program. The program is mainly aimed at accelerating the development of new therapies for dealing with this disease.

Pluristem focuses on using PLX cell treatment regimen. These cells are available off the shelf and may be manufactured in bulk quantities. Pluristem CEO and President Yaky Yanay said, We are receiving many inquiries and requests for treatment from healthcare providers and families worldwide. In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, as well as expanding treatment under compassionate use in other countries. PLX cells are allogeneic mesenchymal-like cells and demonstrate immunomodulatory properties.

Pluristem Therapeutics is mainly invested in developing regenerative medicines and placenta-based cell therapy products. The company has solid development pipeline and has several products in late-stage clinical trials. PLX cell drug candidates are expected to work by releasing different therapeutic proteins in response to radiation damage, inflammation, muscle trauma and ischemia. Pluristem also owns and manages a GMP certified research and manufacturing facility.

Thanks for reading. At the Total Pharma Tracker, we do more than follow biotech news. Using our IOMachine, our team of analysts work to be ahead of the curve.

That means that when the catalyst comes that will make or break a stock, weve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Orgenesis Acquiring Tamir, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha

Clinical Research Forum to Host Virtual Top Ten Clinical Research Achievement Awards – Business Wire

WASHINGTON--(BUSINESS WIRE)--The Clinical Research Forum (CR Forum), along with the Clinical Research Foundation, has announced it will broadcast its annual Top Ten Clinical Research Achievement Awards ceremony virtually this year, and will be available to view on Wednesday, April 15 at 11 a.m. Eastern Time. Participants may register for the event by contacting admin@clinicalresearchforum.org.

The Top Ten Clinical Research Achievement Awards support clinical researchers and advocates in their important and difficult mission of researching and delivering new treatments for ailments across the globe. By recognizing outstanding achievement in clinical trials and highlighting the best success stories in clinical research, the awards draw attention to the importance of and our national investment in clinical research. The virtual nature of this years event, a result of the current Coronavirus (COVID-19) outbreak, further illustrates how essential clinical research is for public health.

These awards highlight ten studies that demonstrate a vital impact on patient care. Submissions for the Top Ten Awards program come from United States-based academic, medical, and/or health centers and include research that crosses multiple disciplines of medicine.

The published clinical research was evaluated by CR Forum leadership, led by Board Chair Dr. Harry Selker, Vice Chair Dr. Herbert Pardes, and Top Ten Clinical Research Achievement Awards Program Chair Dr. E. Albert Reece, along with the entire CR Forum Board. Each study considered for an award this year contained high-caliber research and shows promise of providing much needed relief for patients suffering from disease.

The CR Forum is pleased to announce the following recipients of the Top Ten Clinical Research Achievement Awards:

Three of the studies will receive recognition and cash awards in addition to recognition as one of the Top Ten Clinical Research Achievements Award for 2020.

Research and delivery of new treatments takes years to achieve. This vital work depends on funding from multiple sources, including the National Institutes of Health (NIH), pharmaceutical companies, foundations, patient advocacy organizations, and other sources. CR Forum recognizes that clinical researchers need encouragement, recognition, and continued funding to carry out the needed work to improve treatment for patients across the globe. Global investment in clinical research has paid dividends for patients world-wide.

Past award winning studies include:

For more information, please visit our website at http://www.clinicalresearchforum.org/2020Top10Awards.

About the Clinical Research Forum

The mission of the Clinical Research Forum is to provide leadership to the national and clinical translational research enterprise and promote understanding and support for clinical research and its impact on health and healthcare. For more information, visit http://www.clinicalresearchforum.org.

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Clinical Research Forum to Host Virtual Top Ten Clinical Research Achievement Awards - Business Wire

Predictive Submits Emergency Use Authorization Application for Treatment of Acute Respiratory Distress Syndrome Secondary to COVID -19 with Umbilical…

SALT LAKE CITY, April 13, 2020 (GLOBE NEWSWIRE) -- Predictive Biology, a wholly owned subsidiary of Predictive Technology Group (OTC PINK: PRED) (Predictive or The Company), announced that on April 9th it submitted an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for the immediate use of mesenchymal stem cells (MSCs) derived from umbilical cord tissue for the treatment of Acute Respiratory Distress Syndrome (ARDS), secondary to SARS-CoV-2, coronavirus disease 2019 (COVID-19).

The pandemic caused by COVID-19 has shown to develop into severe ARDS in 30% of hospitalized patients with a 22%-62% mortality rate (Murthy et al., 2020) for those requiring hospitalization in an intensive care unit. Currently, there is no confirmed treatment that can demonstrate safety or efficacy for the treatment of COVID-19.

Coronavirus can be deadly, in large part because the virus can cause cytokine storms in which the patients own immune system triggers a runaway response causing more damage to the patient, than to the virus it's trying to eliminate, said John Sorrentino, Chairman of Predictive Technology Group. Respiratory distress kills hundreds of thousands of people each year worldwide. There is clinical data from early clinical trials that seem to indicate that the avoidance of the cytokine storm utilizing MSCs may be a critical component for the treatment of COVID-19 infected patients.

A recent review article published in Pain Physician, concluded that, The limited but emerging evidence regarding UC MSC [umbilical cord mesenchymal stem cells] in managing COVID-19 suggests that it might be considered for compassionate use in critically ill patients to reduce morbidity and mortality in the United States.

The proposed IND clinical trial will utilize Predictives proprietary core technology of naturally occurring MSCs derived from umbilical cord tissue (UC-MSCs) to assess the efficacy as an add-on therapy to standard treatment of patients with severe Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19.

Predictives UC MSC product, CoreCyte, [currently regulated by the FDA as a tissue-based product under 21 CFR 1271.3(d)(1) and Section 361 of the Public Health Service Act] has already beenused as an allograft in over50,000 patients. Physicians have reported to Predictive that over 1,100 patients have been treated with CoreCyte via intravenous administration. No serious adverse events have been reported with CoreCyte regardless of the route of administration. If Predictives EUA request is approved, CoreCyte would be available immediately to critically ill patients with ARDS due to COVID-19 infections.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize and personalize precision patient care. The Companys entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests and companion therapeutics in order to support a patient from diagnosis through treatment.

Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictives tests and products empower clinicians to provide their patients with the highest level of care. For more information, visit http://www.predtechgroup.com

About Predictive Biotech, Inc.

Predictive Biotech is a leader in regenerative medicine, its products are derived from tissue sources rich in properties that support the bodys natural ability to heal itself. All products are safely, ethically and minimally processed to deliver allografts that preserve the naturally occurring characteristics and factors of the donor tissue. Predictives signature products are uniquely born from the Whartons jelly layer of the umbilical cord and amniotic fluid and tissue.

With over 100,000 units delivered, product safety and consistency has been realized by thousands of practices throughout the United States. A national network of clinics, health systems, researchers and physicians leverage Predictives four proprietary products: AmnioCyte, AmnioCyte Plus, PolyCyte, and CoreCyte.

Forward-Looking Statements:

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks The Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect The Company's current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect The Company's business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by The Company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Predictive BiotechInfo@predictivebiotech.com888-407-9761

Investor ContactJeremy FefferLifeSci Advisorsjeremy@lifesciadvisors.com212-915-2568

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Predictive Submits Emergency Use Authorization Application for Treatment of Acute Respiratory Distress Syndrome Secondary to COVID -19 with Umbilical...

Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3…

More than 25 EINDs approved by FDA for leronlimab use in COVID-19 patients

Phase 2 trial - As of last week, 12 patients enrolled from 2 sites; 3 more sites to initiate enrollment this week, for a total of 5 sites

Phase 2b/3 trial - First hospital cleared to enroll patients beginning today

VANCOUVER, Washington, April 13, 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 a comprehensive update and overview of the therapeutic indications from over 30 COVID-19 patients recently treated with leronlimab in over 4 hospitals and clinics throughout the country. More than 25 hospitals, to date, have requested participation in the Companys trials.

Patient enrollment in the Companys two clinical trials and Emergency Investigational New Drug (EIND) is as follows:

-- More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA). -- Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen. -- As of last week, 12 patients have been treated in the Phase 2 trial for mild-to-moderate COVID-19 indications and, because it is a double-blinded, placebo-controlled trial, results are not yet available. -- First site cleared to enroll patients in Phase 2b/3 beginning today.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We continue to coordinate around the clock with healthcare professionals across the country to deliver leronlimab to patients and we are in regular contact with the FDA to ensure they receive current patient data. We are planning to rapidly enroll 75 patients and report the results to the FDA as quickly as possible.

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 the virus is highly contagious. COVID-19 typically transmits 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. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal 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 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 could 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 may play a role in tumor invasion, metastases, and tumor microenvironment control. 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.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial 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 support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific 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 late-stage 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 critical 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 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 April 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. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it 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, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained 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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Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3...

CDC removes chloroquine from guidance on COVID-19 therapy – Tampa Bay Times

Earlier this week, the U.S. Centers for Disease Control and Prevention removed from its website guidance telling doctors how to prescribe and treat COVID-19 patients with hydroxychloroquine and chloroquine, anti-malarial drugs recommended by President Donald Trump and later, Gov. Ron DeSantis, to treat COVID-19. the disease caused by the novel coronavirus.

The guidance originally said: Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some U.S. clinicians have reported anecdotally on several ways to prescribe the medication of COVID-19, and listed suggested dosages.

As of Tuesday, the website no longer includes dosing information and instead says: There are no drugs or other therapeutics approved by the U.S. Food and Drug Administration to prevent or treat COVID-19.

Meanwhile in Florida the demand for the drug from the governors office continues to ramp up, while medical professionals are practicing more caution given the scant evidence of the drugs effectiveness.

At a briefing Tuesday, the same day the CDC walked back guidance on the drug, DeSantis gave it a shout-out. He said he loosened shipments from India to free up supplies in the state, and played testimonials on the drug from Florida doctors and a patient via livestream.

A few weeks prior, Trump praised the pairing of hydroxychloroquine and azithromycin, an antibiotic, saying they have a real chance to be one of the biggest game changers in the history of medicine.

He has touted it at several coronavirus task force briefings since, despite hesitation from NIAID Director Anthony Fauci, who warned that making claims is premature without a clinical trial and a randomized study.

Soon after Trumps initial announcement, the Food and Drug Administration authorized emergency use of the drug for COVID-19 patients who are severely ill and hospitalized. The order also lifted restrictions on the drugs manufacturer to get more of the medication. The drug is often prescribed for patients with lupus.

As this thing was first discussed in Washington and the FDA made their decision on it ... I reached out to physicians and just, you know, asked them, Hey, whats the deal with this? DeSantis said Tuesday. We want to obviously give patients all the opportunities toward recovering.

Israeli-based Teva Pharmaceuticals provided Florida with a shipment of hydroxychloroquine this week, following a shipment sent last month, Politico Florida reported.

Doctors and scientists have expressed some skepticism over use of the drug, especially given the lack of research and testing from the global medical community.

I usually dont take medical advice from governors, said Dr. Dushyantha Jayaweera, a physician and researcher at the University of Miami Health System and the Miller School of Medicine. We are not under pressure from anybody.

Jayaweera, who is beginning his own randomized trial of 15,000 Florida health care workers and first responders in the coming weeks, said while University of Miami physicians are using hydroxychloroquine for what is called off-label use in COVID-19 patients, everything is very fluid when it comes to how patients respond.

While early studies have shown that the drug does work to reduce viral load in sick patients, the studies arent perfect. Patients may be receiving other types of drugs or stem cell treatments that could impact their results.

There are also risks. The potential side effects of hydroxychloroquine were highlighted by the Mayo Clinic last month, and came to light recently after a hospital in France stopped using the drug on at least one coronavirus patient after it became a major risk to their cardiac health.

These are quick and dirty studies ... the general consensus is that we want to have a clinical trial, Jayaweera said. In the scientific community, we have to answer the basic questions.

Meanwhile, doctors are doing what they can to make sure as many patients as possible survive. Jayaweera said he and others use hydroxychloroquine because theres no other option but that he doesnt recommend it as a policy.

When patients are sick you are very nervous to do a randomized control trial [of a drug], he said. You give the best thing you can think of for the patient because its an emergency.

On Thursday, the Wall Street Journal reported that Chinese doctors who have been treating coronavirus patients with chloroquine for months say there is no clear evidence the drug is effective against COVID-19.

On a conference call hosted by the Miami Chamber of Commerce Thursday, Department of Emergency Management Director Jared Moskowitz clarified that the state is not making any recommendations when it comes to treating COVID-19 patients.

We are leaving it up to hospitals and doctors and medical practitioners at the local level to make those decisions, he said.

Dr. Eneida Roldan, a physician and CEO of the FIU Health Care Network who was also on the call, warned of instances where people have treated themselves with the drug, like an Arizona man who died after officials said they treated themselves with a popular fish tank additive that has the same active ingredient as the anti-malaria drug.

You need to follow your doctors orders, not just going on a website and buying hydroxychloroquine, she said.

However, she noted the drugs could help patients under the proper care of a doctor.

Theres still a lot of unknowns, but we know for a fact that patients have done very well under the observation of a doctor, she said.

The back-and-forth comes as a clinical trial by the National Institutes of Health began Thursday to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with COVID-19 with the first participants now enrolled in Tennessee.

James Kiley, director of the Division of Lung Diseases under the National Institutes of Health, said in a statement that while hydroxychloroquine has showed promise in a lab setting, its hard to know its potential efficacy in studies with patients.

We really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19, he said.

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CDC removes chloroquine from guidance on COVID-19 therapy - Tampa Bay Times