Category Archives: Georgia Stem Cells

COVID-19 has spread around the planet, sending billions of people into lockdown as health services struggle to cope. The statistics are startling global cases stand at 23,139,628 and with a total death toll of 801,795 and new daily cases rising (John Hopkins University data 23 Aug 2020), the outbreak has thrown an unprecedented challenge to the world and its citizens. So far, there is no approved treatment or vaccine.

While researchers around the world continue to explore different ways in combating COVID-19, some are looking into how cannabis derived CBD can offer benefits for those suffering from severe forms of this infection.

One recent study from the Dental College of Georgia and Medical College of Georgiashowed high CBD formulations could be effective in the treatment of acute respiratory distress syndrome, or ARDS. The condition, also known as a cytokine storm, has been seen in serious cases of coronavirus, and even affects patients with other viruses or autoimmune diseases. With ARDS, the patients own hyperactive autoimmune system inundates organs with cytokines, resulting in dangerous inflammation. This reaction can cause lung damage and eventual death in COVID-19 victims.

The study model showed CBD down-regulated the cytokines, which helped improve oxygen levels and supported recovery of damaged lung tissues. The researchers also intend to perform similar studies to understand how CBD might help other organs recover from the effects of the virus. Researchers from University of Nebraska and the Texas Biomedical Research Institute also took part. In apeer-reviewed article in Brain, Behaviour, and Immunity, the authors said further research is needed to understand if CBD can help patients infected by the virus.

Now early results from an ongoing Israeli study is adding to the growing evidence that cannabis ingredients could be a game changing treatment in the fight against COVID-19. The new terpene study is being performed by two Israeli research and development companies,Eybnawhich specializes in terpene based medicines, and CannaSoul Analytics. The study looks at a proprietary terpene formulation called NT-VRL, which was created by Eybna to treat inflammatory conditions such as the cytokine storm syndrome found in COVID-19 patients. The formulation contains 30 individual terpenes that are potential anti-inammatory agents all working together to create a positive impact.

While results are ongoing and are yet to be completed, peer reviewed or published, these are positive steps that warrants further investigation into the application of CBD.

This is far from the only investigation into CBD medical benefits.

Researchers at the University of Lethbridge in Alberta,Canada, revealed at the beginning of July that certain kinds of high CBD strains could help treat people infected with the virus or even prevent it from developing in the first place by managing to reduce virus receptors.

Study authors found extract from high CBD strains could help to regulate an enzyme that coronavirus attaches to thereby blocking the viruss ability to infect cells. Results were published on peer review website Preprints.

In Israel, there are several companies and trials underway on how CBD can be used to battle COVID-19. One such example is the partnership of InnoCan Pharma and Tel Aviv University who are working on a new treatment for COVID-19 using exosomes loaded with CBD. Exosomes are small particles created when stem cells multiply. The method will utilise the exosomes as homing missiles, as they can uniquely target cell organs that have been damaged.

As it stands, CBD is still an area under development for the treatment of COVID-19. While there have been some promising results on CBDs anti-inflammatory properties, more studies are needed before leading into clinical trials to test effectiveness. This can take anywhere from months to years.

Speed, agility, and innovation are required from governments, businesses, and society in crafting responses to cope with this evolving new normal. In this period of uncertainty, every therapeutic opportunity and avenue must be considered. CBD opens the door to various exciting possibilities.

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COVID is shifting the conversation about the medical application of CBD - Open Access Government

NEW YORK, June 03, 2020 (GLOBE NEWSWIRE) -- Cytovia Therapeutics, Inc (Cytovia), an emerging biopharmaceutical company developing Natural Killer (NK) immunotherapies for cancer, today announces the appointment of Dr. Wei Li as acting Chief Scientific Officer (CSO), effective June 1, 2020.

During her biotech career, Dr. Li co-founded two companies and built up extensive expertise in all aspects of drug research and development, including preclinical development and pharmacology, clinical development and operations, regulatory affairs, biomarker development and biomanufacturing.

Most recently, Dr. Li was Chief Development Officer at OliX Pharmaceuticals, a leading public South Korean biotech company developing siRNA therapeutics for multiple indications. She also served as Executive Vice President, Product Development at Boston Biomedical, Inc (BBI) from 2007-2018, playing a key role in growing it from a start-up in 2007 to an industry leader in cancer stem cell research, including through the acquisition by Sumitomo Dainippon in 2012. Dr. Li led the development of napabucasin (BBI608), a first-in-class drug selected as one of the worlds top ten cancer drugs in late stage clinical development by Fierce Biotech. Dr. Li started her career at ArQule, a public biotech company developing targeted therapies for hematological malignancies and acquired by Merck &Co in 2019.

Wei Li holds a PhD in Molecular Virology from Georgia State University and completed her Postdoctoral Training at Harvard Medical School.

Dr. Wei Li said: I am thrilled to be joining the great team of scientists and entrepreneurs at Cytovia Therapeutics. NK-cell based therapeutics are at an inflection point. Initial clinical trials have shown promising safety and efficacy. Off-the-shelf manufacturing promises broader and faster patient access. Cytovia Therapeutics has an excellent iPSC CAR-NK platform and a strong pipeline in both hematological and solid tumors. It is tremendously exciting to be involved in this stage of the companys development.

Dr Daniel Teper, co-founder, Chairman and CEO of Cytovia Therapeutics, Inc said: We are delighted to welcome Dr. Wei Li to Cytovia Therapeutics as Chief Scientific Officer. Wei has a stellar track record of bringing innovative oncology drugs from discovery to clinical development. Her operational excellence and entrepreneurial drive will be critical to help bring multiple iPSC CAR NK therapeutics to initial clinical trials starting in 2021.

ABOUT CYTOVIA THERAPEUTICS, INCCytovia Therapeutics is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem and Macromoltek.

Learn more at http://www.cytoviatx.com

Contact for media enquiries at Cytovia Therapeutics, IncSophie BadrVP corporate Affairs Sophie.badre@cytoviatx.com1(929) 317 1565

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Cytovia Therapeutics, Inc appoints Dr. Wei Li as Chief Scientific Officer to accelerate the development of iPSC CAR-NK Cell Therapy for Cancer - Yahoo...

A local hospital is using a little-known medicine to treat COVID-19 patients after the FDA authorized compassionate use approval to administer the drug.

Landmark Hospital of Athens treated two patients with its first doses of the medicine last week, according to a press release from Landmark Hospitals, which operates six long-term acute-care hospitals in the Southeast, including its Athens hospital on Sunset Drive.

The medicine, called Organicell Flow, is a biologic product derived from amniotic fluid, which contains stem cells. Amniotic fluid is the protective fluid in the sac containing growing fetuses.

Landmark is providing the product to patients with advanced COVID-19 conditions, according to the company.

After receiving Organicell Flow intravenously last week, the two patients were clinically stable as of Wednesday, according to Landmark.

Organicell Regenerative Medicine of Boca Raton, Fla., manufactures the medicine from human amniotic fluid voluntarily donated during Cesarean section surgeries, according to Landmark.

Developed to promote wound healing, Organicell Flow contains more than 300 growth factors, cytokines and chemokines, as well as hyaluronic acid and exosomes, according to the press release.

The medicine can modulate a patients immune response. In some COVID-19 patients, their supercharged immune response can be as harmful as the actual coronavirus that causes COVID-19.

The condition, called cytokine storm syndrome, can damage lungs and other organs and can lead to death, said Landmark Hospitals Chairman Dr. William Kapp.

The data collected from the patients receiving compassionate use treatments will guide us to interventions that modulate COVID-19 immune response in the lungs and reduce systemic organ damage, Kapp said in Landmarks press release.

Organicell Flow is one of a number of medicines health providers around the world are trying out to treat COVID-19, which has claimed more than 100,000 lives in the United States so far and nearly 2,000 in Georgia.

Two other Athens hospitals have also recently received shipments of another drug that may help patients with COVID-19, remdesivir.

Gov. Brian Kemp announced earlier this week that the state was distributing more than 18,000 vials of remdesivir to more than 80 Georgia hospitals, enough to treat nearly 17,000 patients. The hospitals include Athens St. Marys Healthcare System and the Piedmont system that includes Piedmont Athens Regional and several other Georgia hospitals.

Remdesivir is being used to treat patients with serious symptoms such as low oxygen levels or pneumonia, according to the Georgia Department of Public Health.

Developed to treat people with Ebola virus disease, remdesivir has been shown to shorten the time of recovery from COVID-19 illness in hospitalized patients, but in the absence of thorough studies is considered investigational.

Standard treatment for COVID-19 includes oxygen therapy, mechanical ventilation and medicine to maintain blood pressure.

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Athens hospital using biologic treatment on COVID-19 patients - Online Athens

Research focuses on mans exposure prior to contraception

A new study from the University of Georgia has shown that exposure to a now-banned flame retardant can alter the genetic code in sperm, leading to major health defects in children of exposed parents.

Published recently in Scientific Reports, the study is the first to investigate how polybrominated biphenyl-153 (PBB153), the primary chemical component of the flame retardant FireMaster, impacts paternal reproduction.

In 1973, an estimated 6.5 million Michigan residents were exposed to PBB153 when FireMaster was accidentally sent to state grain mills where it made its way into the food supply. In the decades since, a range of health problems including skin discoloration, headache, dizziness, joint pain and even some cancers have been linked to the exposure.

More striking, the children of those who were exposed seemed to experience a host of health issues as well, including reports of hernia or buildup in the scrotum for newborn sons and a higher chance of stillbirth or miscarriage among adult daughters.

Yet, little work has been done to understand how the chemical exposure could have impacted genes passed from an exposed father, said study author Katherine Greeson.

It is still a relatively new idea that a mans exposures prior to conception can impact the health of his children, said Greeson, an environmental health science doctoral student in Charles Easleys lab at UGAs College of Public Health and Regenerative Bioscience Center.

Most studies where a toxic effect is observed in children look only to the mothers and the same has been true of studies conducted on PBB153, she said.

Greeson and a team of researchers from UGA and Emory University used a unique combination of observational and laboratory approaches to demonstrate how PBB153 acted on sperm cells.

Typically, scientific studies are either epidemiological in nature and inherently observational or focus on bench science, but in this study, we did both, said Greeson.

This approach allowed the researchers to mimic the known blood exposure levels of PBB153 in a lab environment.

We were uniquely able to recreate this effect using our previously characterized human stem cell model for spermatogenesis, she said, which allowed us to study the mechanism that causes this effect in humans.

The team looked at the expression of different genes in their human spermatogenesis model after dosing with PBB153 and found marked alterations in gene expression between dosed and undosed cells, specifically at genes important to development, such as embryonic organ, limb, muscle, and nervous system development.

PBB153 causes changes to the DNA in sperm in a way that changes how the genes are turned on and off, said Greeson. PBB153 seems to turn on these genes in sperm which should be turned off, said Greeson, which may explain some of the endocrine-related health issues observed in the children of exposed parents.

Though the study used this model to directly replicate exposure to PBB153, Greeson says this approach could be used to better understand the impact of other environmental exposures on reproduction, including large-scale accidental exposures to toxic chemicals or everyday exposures.

Hopefully this work will lead to more studies combining epidemiology and bench science in the future, which will tell us more about why were seeing an effect from an environmental exposure in human populations and encourage experimental studies to more closely mimic human exposures, she said.

The study, Detrimental Effects of Flame Retardant, PBB153, Exposure on Sperm and Future Generations, published May 22. It is available online.

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Study reveals birth defects caused by flame retardant - University of Georgia

FDA has approved 54 Emergency INDs to allow access to leronlimab for severely and critically ill COVID-19 patients

VANCOUVER, Washington and WINSTON-SALEM, N.C., May 07, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (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 Novant Health is initiating patient enrollment in CytoDyns Phase 2b/3 trial for severely and critically ill COVID-19 patients.

Leronlimab has been administered to 54 severely and critically ill COVID-19 patients thus far under Emergency Investigational New Drug (EINDs) authorizations granted by the U.S. Food and Drug Administration (FDA). Preliminary results from this patient population led to the FDAs recent clearance for CytoDyns Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.

Were grateful for our partnership with CytoDyn and the opportunity to bring cutting edge, innovative and investigative treatments to our community, said Eric Eskioglu, M.D. Executive Vice President and Chief Medical Officer for Novant Health. Since initiating the leronlimab mild/moderate last month, Novant Health has screened nearly 400 patients for eligibility. A number of these patients have been enrolled and treated on the mild/moderate clinical trial. Expanding treatment options for our more critically ill patients is a vital step in our fight against COVID-19. We are encouraged by early reports of efficacy of leronlimab from critically ill patients treated under an Emergency Use IND and we are eagerly awaiting the full results of both blinded studies for leronlimab in the near future from CytoDyn.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, added, We are once again very pleased Novant Health is seeking to partner with our health care professionals to help provide a potential therapeutic benefit to these COVID-19 patients. Thus far, we are grateful for the benefits leronlimab has provided to so many patients, as expressed to us by their families.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals and clinics throughout the country.

SARS-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) and BLA Submission for the HIV Combination TherapyThe 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).

Story continues

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. We would like to provide an update that the Biologics License Application (BLA) for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients will be considered completed after the clinical datasets are submitted on May 11, 2020. The clinical datasets are updated to address FDA comments for mock datasets from March 12 and March 20, 2020. After the BLA submission is considered completed, FDA makes a filing decision and sets a PDUFA goal date. CytoDyn has Fast Track designation and a rolling review previously assigned by the FDA and plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

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 aPhase 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 Novant Health Novant Health is an integrated network of physician clinics, outpatient facilities and hospitals that delivers a seamless and convenient healthcare experience to communities in Virginia, North and South Carolina, and Georgia. The Novant Health network cares for approximately 5 million patients annually at nearly 700 locations, including 15 hospitals and hundreds of outpatient facilities and physician clinics.

About CytoDynCytoDyn 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 atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains 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 Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-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, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

Excerpt from:
Novant Health Initiates Phase 2b/3 Trial with CytoDyns Leronlimab for Severely and Critically Ill COVID-19 Patients - Yahoo Finance

54 eINDs approved by FDA and 49 patients have been treated with leronlimab thus far

VANCOUVER, Washington, April 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced updates on 49 COVID-19 patients who have received leronlimab under the U.S. Food and Drug Administrations (FDA) emergency Investigational New Drug (eIND) program:

Eleven (11) Patients in NY hospital: All treated patients were in Intensive Care Units (ICU) because of acute respiratory failure, eight of whom were intubated (placed on mechanical ventilation). One patient was not intubated because of poor baseline pulmonary status (history of lung cancer and had undergone bilateral upper lobectomy). Seven patients were organ-transplant recipients (six patients were renal-transplant recipients and one patient had a history of heart transplant) and were on immunosuppressive regimen. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, we believe we were able to save the lives of four patients. All patient blood samples were evaluated and important powerful results from the effect of leronlimab were demonstrated in almost all of these patients. This data has been submitted to a prestigious journal and we expect the publication on Friday, May 1.

Twenty-three (23) patients in Southern California hospital: Six patients were in critical condition (intubated) and 17 patients were severely-ill, needing oxygen support. No death was reported. Out of 6 critical patients, all were intubated patients, 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator and one patient has shown deterioration in respiratory parameters. Of 17 severe condition (but not critical) patients, 11 patients demonstrated improvement in respiratory parameters (8 of them were discharged from hospital, including one patient in the news, Samantha Mottet), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients.

Three (3) patients in Georgia hospital: All three ICU patients were intubated and two of them had renal failure at the start of leronlimab treatment. Of these 3 patients, 2 were extubated (taken off ventilator) and 1 patient remains on a ventilator but improving.

One (1) patient in another NY hospital: Patient was taken off oxygen and discharged from hospital after leronlimab treatment.

One (1) patient in Northern California hospital: Patient is now weaning from ventilator and transferred to rehabilitation hospital.

Updates are pending for 10 other patients. Five additional patients have been approved to receive leronlimab under eINDs, which increases the total eINDs approved by the FDA to 54 patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostics company and an advisor to CytoDyn, expanded on these findings by stating, We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system. With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

Story continues

SARS-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 aPhase 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 CytoDynCytoDyn 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 completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. 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 atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains 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. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. 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 Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-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, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries -...

Scientists are skilled at tackling unexpected problems that threaten the integrity of their experiments it comes with the territory. But the coronavirus pandemic poses a new and entirely unprecedented challenge.

The global health emergency has shut down scientific research labs across the country in a crisis that has left some scientists scrambling to save their work and has left others grieving the loss of experiments they had dedicated months or even years to carrying out. Many are grappling with an overwhelming sense of uncertainty about how theyll continue their work.

The situation has hit early-career researchers particularly hard. Their funding and their futures depend on quickly gathering data to publish in prestigious journals. Without additional financial support and an extension of tenure clocks, some scientists who have just started their own labs fear the delays to their studies may be too disruptive to overcome.

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Early-career scientists will be very vulnerable, said Cullen Taniguchi, assistant professor at University of Texas MD Anderson Cancer Center. Taniguchi said it will be crucial to properly support researchers when labs reopen or, he warned, we may lose a whole generation of researchers because of this.

Despite these struggles, many researchers say that shutting down the labs was necessary to stem the spread of the virus. And some labs are still up and running, though not all are doing so at full capacity. But for scientists whose work has been deferred, the closures have fueled a devastating ripple effect of consequences, both big and small.

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Even when laboratories are reopened, it may take months to a year for research to resume as normal.

I have [new hires] in the lab that havent even met each other physically, said Alice Soragni, a cancer researcher and assistant professor who runs a lab at the University of California, Los Angeles. There is a lot of training that needs to have happened that hasnt happened, she added.

STAT spoke to scientists across the country to better understand the wide-ranging impacts of lab shutdowns.

Scientists have transitioned from long hours in the laboratory to working from home but the abrupt halt to their research projects has left a lingering sense of disorientation for researchers like Kathleen Beeson, a sixth-year graduate student at Oregon Health and Science University.

Like many of her colleagues, Beeson was caught off guard by her labs closure.

We were given a weeks notice,she said. Immediately, I and others were in a race to finish experiments, collect any data that we could, and get the lab prepared for a minimum of six weeks of shutdown.

Beeson had been completing a final experiment for a publication she needs to earn her Ph.D. and move onto a postdoc research position at Harvard Medical School.

The shutdown has upended Beesons research, which involves measuring electrical activity in the brains of genetically engineered mice. Her work aims to describe how proteins at the junction of nerve cells help transmit chemical signals an important step in understanding neurological dysfunctions such as epilepsy.

While other scientists were able to freeze cells or preserve tissue samples in formaldehyde, Beesons research relied on analyzing freshly dissected brain tissue. Because she could no longer come into the lab, she had to sacrifice most of her mouse colony, which she had painstakingly raised from one male and one female to approximately 200 animals.

In the end, I found myself euthanizing mice by the masses in the university basement, she said. It was the punctuation on a sad and disorienting week.

Beeson said it will likely take her months to raise enough animals for experiments again. In the meantime, she has been working on her Ph.D. dissertation and a second publication from home although not at the pace that she had hoped for.

I applaud anyone making any progress, on anything, during this time, she said. Sometimes my progress is processing my grief.

Disruptions to research and long startup times pose an especially daunting challenge to early-career scientists who have just a few years to establish themselves as experts in their fields and obtain critical funding for their laboratories.

With experiments on hold, some early-career scientists cant collect the kind of preliminary data that is crucial for them to compete with more established researchers who have a decade or more of experimental findings to build on.

[All researchers] are impacted but I think there are exquisite challenges for early-career investigators like myself, said UCLAs Soragni.

To protect early-career scientists, the NIH has extended the time frame for which researchers can be considered early stage investigators a status that helps government institutes and centers prioritize funding for scientists running new laboratories. The agency has also relaxed some of the eligibility requirements for maintaining grants and added additional flexibility for spending funds.

Despite these welcome efforts, early-career researchers especially those lacking data needed to apply for new grants remain in a precarious position. Soragni and others said they hoped the NIH would take the impact of Covid-19 into account and temporarily adjust its criteria for reviewing applications. However, the agency has recommended that scientists without enough preliminary data submit their applications at a later date.

For Soragni, the most difficult challenge has been the uncertainty.

You are kind of left not knowing what you should do. Should you be ramping up completely? But what if you are switched down again?

Alice Soragni, UCLA cancer researcher

We really dont know if we are going to have a second wave of infections and what will be the consequences, she said. You are kind of left not knowing what you should do. Should you be ramping up completely? But what if you are switched down again? Should you be hiring? Will the economy bounce back? What is going to happen to your grants?

We are just at a more vulnerable stage of our career, Soragni said. I believe we may lose some laboratories to this, so that will be very painful to witness.

The shutdowns have taken a toll not only research, but also on the close professional relationships at the heart of scientific collaboration.

For Stephanie Campos, Covid-19 meant that she would not complete her research or be able to say goodbye to her mentor, Walter Wilczynski, in person. Campos had come to Georgia State University for a postdoctoral fellowship with Wilczynski, a pioneer in the field of behavioral neuroscience and the first director of the universitys Neuroscience Institute. But after 37 years of research, the lab was scheduled to close this summer after Wilczynskis cancer, once in remission, returned.

Campos and her colleagues were wrapping up their research a study of the brain activity in lizards aimed at unraveling the neural underpinnings of social behaviors when the pandemic hit. The lab shuttered earlier than expected.

With the laboratory closed, Campos has been limited to writing manuscripts from home and analyzing old videos of lizard behavior. She cant see Wilczynski who is immunocompromised again in person before she moves to a new role as a visiting assistant professor at Swarthmore College.

[This experience] has really affected me emotionally in the way that I knew I was going to be his last student, Campos said. And so I had really wanted to get as much as I could.

With Georgia easing restrictions on social distancing, there is a possibility that Campos could return to the lab late in the summer, but she is still unsure if returning to work would be socially responsible. Instead, she is planning on mailing the bulk of her delayed research project which involves 68 lizard brains preserved in vials of paraformaldehyde to Pennsylvania, where she will begin work in August.

Campos credits Wilczynski, who was at times too fatigued to read papers, for guiding her through the gauntlet of an academic job search and giving her the confidence to continue in academia.

His kindness during this time is what Ill remember the most, Campos said. For me it is all about the personal connection, how well your mentors make you feel. Those are the things that I will take away.

Waiting for their labs to reopen, principal investigators are steeling themselves for the months of effort that will be needed to reestablish the rhythms of a productive laboratory.

Theres a mountain of work to muddle through before experiments can get off the ground again.

We will have to first retest [our equipment] to make sure it is working, regrow our [bacterial] cultures, which takes a while, before we can even consider doing an experiment, said Eric Rubin, an immunology and infectious diseases researcher and professor at the Harvard T.H. Chan School of Public Health. Rubin also the editor-in-chief the New England Journal of Medicine.

Regrowing bacteria in Rubins laboratory is not a job for the impatient. The focus of his studies, Mycobacterium tuberculosis, causes tuberculosis and kills more people worldwide than any other infectious pathogen. M. tuberculosis also grows approximately 50 times more slowly than other microorganisms. Experiments that would take a day with other commonly studied bacteria typically take weeks in the Rubin lab.

When laboratories closed, Rubins team was in the midst of testing a batch of promising drug compounds for the ability to kill the bacteria. To resume the study, researchers will have to thaw out stocks of frozen bacteria and coax them to replicate in liquid broth.

We normally always have things growing so that we can grab them and do our next experiment, said Rubin. [But now] it will likely take four months before we will have enough cells to do experiments at full tilt again.

Restarting research may take even longer up to a year for those working with laboratory animals, such as Subhash Kulkarni, a scientist and assistant professor at Johns Hopkins University School of Medicine.

In 2017, Kulkarni showed that, contrary to established dogma, nerve cells lining the intestines continue to grow and divide in adult animals. To understand how this discovery could lead to new treatments for digestive disorders, Kulkarni had begun analyzing how neurons behaved over the lifespan of a mouse. This project required raising genetically engineered mice at staggered times to have enough of each age group at the start of the study.

With his lab closed, the entire effort will have to be repeated once Kulkarni is allowed to work again. That timeline is daunting.

Think of this as the time when the planets are in perfect alignment, Kulkarni said. Once that time is lost, making the next time requires [new] breedings, which can take anywhere from six to 12 months.

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Covid-19 has shuttered labs. It could put a generation of researchers at risk - STAT

VANCOUVER, Washington, Apr 30, 2020 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, today announced updates on 49 COVID-19 patients who have received leronlimab under the U.S. Food and Drug Administrations (FDA) emergency Investigational New Drug (eIND) program:

Eleven (11) Patients in NY hospital: All treated patients were in Intensive Care Units (ICU) because of acute respiratory failure, eight of whom were intubated (placed on mechanical ventilation). One patient was not intubated because of poor baseline pulmonary status (history of lung cancer and had undergone bilateral upper lobectomy). Seven patients were organ-transplant recipients (six patients were renal-transplant recipients and one patient had a history of heart transplant) and were on immunosuppressive regimen. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, we believe we were able to save the lives of four patients. All patient blood samples were evaluated and important powerful results from the effect of leronlimab were demonstrated in almost all of these patients. This data has been submitted to a prestigious journal and we expect the publication on Friday, May 1.

Twenty-three (23) patients in Southern California hospital: Six patients were in critical condition (intubated) and 17 patients were severely-ill, needing oxygen support. No death was reported. Out of 6 critical patients, all were intubated patients, 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator and one patient has shown deterioration in respiratory parameters. Of 17 severe condition (but not critical) patients, 11 patients demonstrated improvement in respiratory parameters (8 of them were discharged from hospital, including one patient in the news, Samantha Mottet), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients.

Three (3) patients in Georgia hospital: All three ICU patients were intubated and two of them had renal failure at the start of leronlimab treatment. Of these 3 patients, 2 were extubated (taken off ventilator) and 1 patient remains on a ventilator but improving.

One (1) patient in another NY hospital: Patient was taken off oxygen and discharged from hospital after leronlimab treatment.

One (1) patient in Northern California hospital: Patient is now weaning from ventilator and transferred to rehabilitation hospital.

Updates are pending for 10 other patients. Five additional patients have been approved to receive leronlimab under eINDs, which increases the total eINDs approved by the FDA to 54 patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostics company and an advisor to CytoDyn, expanded on these findings by stating, We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system. With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results.

About Coronavirus Disease 2019

CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-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 completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. 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. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. 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.

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CytoDyn (OTC: CYDY) Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable...

Stem cell therapy is an incredibly versatile treatment, and one that we specialize in at Southeastern Interventional Pain Associates. If you suffer from pain, muscle tears, stiffness, or other discomforts, you may be able to benefit from stem cell therapy. We offer this treatment to patients in Atlanta, Alpharetta, Sandy Springs, and the surrounding Georgia communities.

Stem cell therapy is an innovative and versatile treatment that uses stem cells to amplify your bodys natural repair process, helping individuals avoid invasive surgery and joint replacement. Stem cells are a special type of cell that have the ability to replace damaged cells in the body. These cells, although small in number, can develop into many different types of cells depending on what the body necessitates. Stem cell therapy involves collecting these unique cells and placing them into the body where a patient is injured. These cells then develop into the necessary cell structure and stimulate natural healing. This process can aid the healing of bone, tissue, tendons, and cartilage.

Adult stem cells are often found in the blood and bone marrow. To begin stem cell therapy, blood and bone marrow samples are taken in order to obtain a concentrated amount of stem cells. After the stem cells are prepared, they are injected directly into the injury site. These cells begin to develop and heal immediately, resulting in a reduction in pain and improvement quickly after treatment.

If you have experienced any significant injuries, you may be able to benefit from stem cell therapy. Stem cell therapy can also be beneficial for patients experiencing:

During your initial appointment, a doctor at Southeastern Interventional Pain Associates in Atlanta, Georgia, will review your medical history and complete a thorough exam to ensure you are a good candidate for stem cell therapy.

Stem cell therapy is an innovative technique that can eliminate the need for surgery during a patients recovery. Contactus today to learn more about the treatment or schedule an appointment. Southeastern Interventional Pain Associates welcomes patients from Atlanta, Alpharetta, Sandy Springs, and the neighboring areas of Georgia.

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Stem Cell Therapy in Atlanta, GA - sipapain.com

Data Bridge Market ResearchLorea is a professional writer with expertise in industry research.

She had worked with many corporates prior to joining research

Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market,By Applications (Eurodegenerative Disorders, Autoimmune Diseases, Cancer & Tumors, Cardiovascular Diseases), By Product (Blood Pressure (BP) Monitoring Devices, Pulmonary Pressure Monitoring Devices, Intracranial Pressure (ICP) Monitoring Devices), By End User (Hospitals And Ambulatory Surgical Center), By Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) Industry Trends and Forecast to 2025

The Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market is expected to reach USD113.04 billion by 2025, from USD 87.59 billion in 2017 growing at a CAGR of 3.7% during the forecast period of 2018 to 2025. The upcoming market report contains data for historic years 2015 & 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.

For In depth Information Get Sample Copy of this Report @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market

In autologous stem-cell transplantation persons own undifferentiated cells or stem cells are collected and transplanted back to the person after intensive therapy. These therapies are performed by means of hematopoietic stem cells, in some of the cases cardiac cells are used to fix the damages caused due to heart attacks. The autologous stem cell and non-stem cell based therapies are used in the treatment of various diseases such as neurodegenerative diseases, cardiovascular diseases, cancer and autoimmune diseases, infectious disease. According to World Health Organization (WHO), cardiovascular disease (CVD) causes more than half of all deaths across the European Region. The disease leads to death or frequently it is caused by AIDS, tuberculosis and malaria combined in Europe. With the prevalence of cancer and diabetes in all age groups globally the need of steam cell based therapies is increasing, according to article published by the US National Library of Medicine National Institutes of Health, it was reported that around 382 million people had diabetes in 2013 and the number is growing at alarming rate which has increased the need to improve treatment and therapies regarding the diseases.

Major Market Drivers and Restraints:

Introduction of novel autologous stem cell based therapies in regenerative medicine

Reduction in transplant associated risks

Prevalence of cancer and diabetes in all age groups

High cost of autologous cellular therapies

Lack of skilled professionals

Browse Detailed TOC, Tables, Figures, Charts and Companies @https://www.databridgemarketresearch.com/toc/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market

The global autologous stem cell and non-stem cell based therapies market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of autologous stem cell and non-stem cell based therapies market for global, Europe, North America, Asia Pacific and South America.

Some of the major players operating in the global autologous stem cell and non-stem cell based therapies market are Antria (Cro), Bioheart, Brainstorm Cell Therapeutics, Cytori, Dendreon Corporation, Fibrocell, Genesis Biopharma, Georgia Health Sciences University, Neostem, Opexa Therapeutics, Orgenesis, Regenexx, Regeneus, Tengion, Tigenix, Virxsys and many more.

Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analysed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more pleaseRequest an Analyst Callor can drop down your inquiry.

Demand Side Primary Contributors: Group Purchasing Organizations, Associations, Insurers, Universities, Technological Writers, Scientists, Promoters, and Investors among others.

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Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market Industry Trends and Forecast to 2025 - News Distribute