Stem Cell Clinic

YOUR HEALTH: Something fishy to help improve eyesight – WQAD.com

Macular degeneration is the leading cause of vision loss for adults over the age of 60

NASHVILLE, Tenn Age-related loss of eyesight affects 11 million people in the United States and that number is expected to nearly double by 2050.

But tiny zebrafish may help improve that outlook.

ish might be tiny, but they come with some supersized powers.

"Zebrafish, unlike mammals, are able to regenerate parts of their retina if they become injured," explained David Calkins, director of the Vanderbilt University Vision Research Center.

Researchers from Vanderbilt University Medical Centerare studying how this characteristic of zebrafish can help humans dealing with age-related vision loss due to damage to the retina.

"The cells that make up the retina between the fish and the human eye are very, very similar," said James Patton, a Vanderbilt Biological Sciences professor.

Except for one cell called MG for Muller Glia.

In a zebrafish, when that cell is damaged it will activate and then regenerate.

"So the fish will go from blind to about two-and-a-half weeks later, total regain of eyesight," Patton added.

Humans have the same Muller Glia cell but are incapable of regeneration like the zebrafish.

But Patton said he is trying to find out if suppressing a certain type of micro-RNA in humans could activate Muller Glia the same way it does in zebrafish.

There is a treatment where stem cells are injected into the back of the eye to see if those stem cells will integrate into the retina and then replace lost cell types.

A stem cell that's already a resident cell in the retina is used to replace all the rest of the lost cells

This is similar to the method that the Muller Glia cell naturally does in the zebrafish.

Right now, theeconomic burden for eye disordersand vision loss sits at $35 billion.

"If there were ways to keep people seeing and overcome degenerative disorders, that would have a huge economic impact, not to mention quality of life," said Patton.

Before human testing, they will have to test on smaller mammals, such as mice and see if they can suppress a particular mirco-RNA that regulates the Muller Glia cell.

If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens atjim.mertens@wqad.comor Marjorie Bekaert Thomas atmthomas@ivanhoe.com.

Follow this link:
YOUR HEALTH: Something fishy to help improve eyesight - WQAD.com

First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency…

VANCOUVER, Washington, April 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID-19 patients have been treated with leronlimab under the Companys Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites.

In addition, the Companys investigational new drug, leronlimab, has now been administered to 15 severely ill COVID-19 patients at four hospitals, 10 patients treated at a leading medical center in the New York City area and five patients at three other hospitals, all under an emergency investigational new drug (EIND), which were granted by the U.S. Food and Drug Administration (FDA) for each individual patient.

CytoDyn also anticipates initiating its other COVID-19 trial this week. This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (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 14 days. The Company will perform an interim analysis on the data from 50 patients following two weeks of leronlimab therapy.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, We are encouraged by the positive results demonstrated with leronlimab in the New York patients. Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimabs mechanism of action.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, Our partnership with the New York medical team and now other hospitals has been exemplary. We are collaborating in every aspect to deliver leronlimab to patients in order to provide proof of concept as soon as possible. The outstanding coordination among the physicians, the hospital administrators, the FDA, and our team, will hopefully help mitigate the deleterious effects from this pandemic should we prove leronlimab as a solution. The lead physician in New York is a true medical hero, who deserves to be recognized for his contribution to humanity in the pandemic of COVID-19. We are very hopeful of sending the day three and day seven results of the first ten EIND patients to the FDA by the end of this week.

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

See the rest here:
First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency...

Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular…

- First-in-class oncology therapeutic candidate YIV-906 applies an integrative systems biology approach -- Global study to evaluate efficacy, safety, and quality of life in patients with hepatitis B-positive hepatocellular carcinoma -

NEW YORK and SHANGHAI, China, April 06, 2020 (GLOBE NEWSWIRE) -- Yiviva today announced that the first patient has been dosed in a Phase 2b study of YIV-906 in combination with sorafenib in the treatment of patients with hepatitis B-positive hepatocellular carcinoma (HCC). YIV-906 is a novel, proprietary therapeutic candidate based on molecular profiling of extracts identified from use in traditional botanical medicine. YIV-906 has demonstrated that it can potentiate the anti-tumor activity of sorafenib, enhance innate and adaptive immune function in the tumor microenvironment, protect cells of the gastrointestinal tract by reducing inflammation mediated by IL-6, NF-kappaB, COX2, iNOS, and accelerate regeneration of damaged gastrointestinal tissue by promoting progenitor and stem cell growth via the Wnt signaling pathway.

Patients and providers are eager to have evidence-based systemic treatment options for cancer, such as YIV-906, commented Edward Chu, M.D., Chief of the Division of Hematology and Oncology, Deputy Director at the UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine and senior advisor to Yiviva. YIV-906 applies a novel systems biology approach that has been shown in preclinical and preliminary clinical studies to enhance immune function in the tumor microenvironment and protect gastrointestinal tissue. Observations of the effects of YIV-906 in proof of concept clinical studies provide a compelling rationale for conducting this large global study in the first-line treatment setting. In addition, patients with hepatitis B-positive HCC represent a population with particularly limited treatment options where the YIV-906 approach could have a particularly significant impact on care.

The development of YIV-906 is a state-of-the-art approach using modern science, bioinformatics, and current GMP manufacturing to develop a precisely engineered botanical medicine, commented Yun Yen, M.D., Ph.D., Co-Global PI Coordinator of the YIV-906 study and former President of Taipei Medical University. The components of YIV-906 have been selected for their expected effects across multiple targets when administered as a complex mixture in combination. Given the major need for better treatments for patients with liver cancer, and the safety and efficacy profile of YIV-906 as seen to date, we look forward to the results of this global study. This could lead to new therapeutic strategies to treat cancer patients holistically.

The randomized, placebo-controlled Phase 2b study of YIV-906 is evaluating efficacy, safety, and quality of life in patients with hepatitis B-positive HCC. The clinical study is designed to enroll approximately 125 patients at 20 sites in the U.S., mainland China, Hong Kong, and Taiwan, including Memorial Sloan Kettering Cancer Center, Taipei Medical University, Queen Mary Hospital in Hong Kong and the China National Cancer Center in Beijing. Patients will be randomized 2:1 to either the study arm (YIV-906 plus sorafenib) or control arm (placebo plus sorafenib). The primary endpoint of the study is an evaluation of progression free survival. Secondary endpoints include safety and quality of life assessments and additional measures of clinical efficacy, including time to progression, overall survival, objective response rate and disease control rate. Change of quality of life will be assessed according to HCC18 and EORTC QLQ-C30 assessments. Additional information is available at https://clinicaltrials.gov/ct2/show/NCT04000737.

About YIV-906

YIV-906 (also PHY906 or KD018) is a therapeutic candidate comprised of a proprietary cGMP botanical extract of four herbs inspired by a traditional Chinese medicine formulation used for over a millennium. YIV-906 has the potential to be developed as a platform oncology therapeutic when administered in combination with chemotherapy, immunotherapy and radiation therapies, in multiple cancer indications. YIV-906 has been shown to enhance immune function in the tumor microenvironment (by polarizing M1 macrophages and activating T cells), protect the gastrointestinal tract (by inhibiting inflammation via IL-6, NF-kappa-B, COX2, and iNOS pathways) and promote intestinal tissue repair (by increasing activity and expression of components of the Wnt signaling pathway). YIV-906 has been observed to enhance the anti-tumor activity of sorafenib in preclinical models of hepatocellular carcinoma and has shown promise in preliminary clinical studies in liver, pancreatic, colorectal and rectal cancers. YIV-906 has been granted Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for development of YIV-906 in the treatment of hepatocellular carcinoma and pancreatic cancer. Yiviva holds worldwide intellectual property for YIV-906 including 32 patents related to methods of use, manufacturing and quality control. YIV-906 is being developed for approval under the U.S. FDA Botanical Drug regulatory pathway.

Story continues

About Yiviva

Yiviva is a clinical stage biotechnology company developing multi-target botanical therapeutics using a systems biology approach, focused on cancer, inflammatory and chronic diseases. The Yiviva STAR (signal transduction, activity and response) discovery platform accelerates the identification of botanical therapeutics that influence immune function, inflammatory responses, cell growth and metabolic functions and hormone activity. Yiviva applies patented, mechanism-based quality control linked to biological activity to satisfy established regulatory requirements for complex products. The company was launched with Yale University as a co-founder and co-founders include Yung-Chi Cheng, Ph.D., with teams in New York, New Haven, Connecticut and Shanghai. For further information, please visit https://yiviva.com.

Contact:Tel: +1 646-883-3906Email: hello@yiviva.com

See the rest here:
Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular...

Coronavirus Business Tracker: How The Private Sector Is Fighting The COVID-19 Pandemic – Forbes

Alain Mrieux, founder of BioMrieux.

Latest update: April 6, 2020, at 5:46 pm ET.

Businesses around the world are shifting into overdrive to help battle the coronavirus, providing everything from rubber gloves and ventilators to diagnostic tools and, hopefully soon, vaccines. While the pandemic continues to wreak havoc, large corporations and small businesses are developing creative solutions to halt the spread of the virus.

Just as automakers famously shifted to make tanks and planes during World War II, todays global giants LVMH, Ford and GE to name a few are retooling their production lines to help make everything from hand sanitizers to respirators. On the medical front, there are more than three dozen COVID-19 vaccines under development, a smart move considering that two out of every three vaccines for infectious diseases fail, according to a study by the Massachusetts Institute of Technology.

Forbes will continue to update this list of private companies and how they are stepping up to fight the COVID-19 pandemic:

Testing:

Abbott Laboratories: Abbott Park, Illinois healthcare firm obtained emergency FDA authorization for its 5-minute coronavirus testing kit on March 27, with plans to start manufacturing 50,000 kits a day.

Alphabet: Through its healthcare arm Verily, Googles parent company launched a website where users can find nearby testing sites in four California counties.

Jeff Bezos.

Amazon: Jeff Bezos retail behemoth invested $20 million in the Amazon Web Services Diagnostic Initiative, which aims to speed up delivery of COVID-19 tests to the market.

BioMrieux: French biotech company, founded by billionaire Alain Mrieux,received emergency FDA approval for its subsidiarys new testing kit, which cuts testing times for the virus down to 45 minutes.

Carbon: California-based 3D printing unicorn backed by Russian tech investor Yuri Milner will soon be distributing testing swabs and face shields to hospitals in the Bay Area.

Cellex: North Carolina biopharma firms antibody-based test for COVID-19 received emergency approval from the FDA.

Cepheid: Sunnyvale, California molecular diagnostics company gained emergency FDA authorization for its new 45-minute COVID-19 testing kit.

Copan Diagnostics: Family-owned company located at the heart of Italys hard-hit Lombardy region makes diagnostic swabs for testing, airlifting 500,000 swabs to the U.S.

DiaSorin: Italian biotech company owned by billionaire Gustavo Denegri obtained emergency authorization from the FDA for its new 60-minute testing kit for COVID-19.

Ipsum Diagnostics: Sandy Springs, Georgia diagnostic company gained emergency FDA authorization for its COVID-19 testing kit.

Mammoth Biosciences: South San Francisco-based biotech startup, founded by three 30 Under 30 alums, prototyped a rapid test by using the gene-editing tool Crispr to detect the disease.

Mesa Biotech: San Diego biotech business obtained FDA approval for its new 30-minute testing kit for COVID-19.

Puritan Medical Products: Maine-based diagnostic maker, one of the worlds largest makers of diagnostic swabs along with Italys Copan Diagnostics, is reportedly increasing production to make one million COVID-19 testing swabs a week.

QIAGEN: Hilden, Germany-based molecular diagnostics firm received emergency approval from the FDA for its new COVID-19 testing kit.

Siemens Healthineers: The German conglomerates healthcare unit received FDA clearance for its blood gas analyzer, which helps doctors monitor the conditions of critical COVID-19 patients in ICUs.

Treatments:

AbbVie: North Chicago-based, publicly traded pharma firm is collaborating with authorities in the EU, the U.S. and China on experimental use of its HIV drug lopinavir/ritonavir to treat COVID-19.

AIM Immunotech: Florida-based pharmaceutical company announced on March 9 it would begin experimental testing of its chronic fatigue syndrome drug rintatolimod as a treatment for COVID-19 in Japan, at the National Institute of Infectious Diseases and the University of Tokyo.

AlloVir: Houston-based cell and gene therapy company is collaborating with Baylor College of Medicine to discover and develop T-cell therapies to fight COVID-19.

Amgen: Thousand Oaks, California biotech outfit is working with Seattle-based Adaptive Technologies to develop antibody-based treatments for COVID-19.

Apeiron Biologics: Vienna-based biotech firm announced it would begin a trial of its immunotherapy treatment on 200 COVID-19 patients in Austria, Germany and Denmark.

Applied Therapeutics: New York-based biopharma outfit is conducting trials of its lung inflammation and cardiomyopathy drug, AT-001, on COVID-19 patients at several hospitals in New York City, including Mount Sinai.

Ascletis: Hangzhou, China pharmaceutical company announced results of clinical trials of its antiviral drug danoprevir on COVID-19 patients in China; the small-scale study found that danoprevir combined with ritonavir is safe and well tolerated in all patients.

Celltrion: South Korean healthcare firm is developing an antiviral treatment for COVID-19, with plans to start human trials in July; the company is also developing rapid self-testing kits that would provide results within fifteen to twenty minutes, expected by the summer.

Celularity: New Jersey-based therapeutics startup obtained FDA clearance to begin trials of a potential stem cell treatment against COVID-19.

Cocrystal Pharma: Bothell, Washington pharma outfit is developing antivirals to treat COVID-19 using patents it recently acquired from the Kansas State University Research Foundation.

CytoDyn: Vancouver, Washington biotech firm announced preliminary results from three days of testing its antiviral drug leronlimab on COVID-19 patients in New York; the company stated in a press release that test results from the first four patients suggests immunological benefit within three days following treatment with leronlimab.

Eli Lilly: Indianapolis pharma company is partnering with Vancouver-based biotech outfit AbCellera to develop antibody-based treatments for COVID-19.

Emergent BioSolutions: Maryland drugmaker is developing treatments derived from the antibodies found in the blood of people who tested positive for the disease.

EUSA Pharma: British pharmaceutical firm initiated trials of its siltuximab antibody treatment on COVID-19 patients at the Papa Giovanni XXIII hospital in Bergamo, Italy; the company released initial data on April 1 showing that one third of patients experienced clinical improvement with reduced need for oxygen support and a further 43% saw their disease stabilise.

Fujifilm: Tokyo-based conglomerates pharmaceutical arm, Fujifilm Toyama Chemical, recently started phase 3 clinical trials of its flu drug favipiravir on COVID-19 patients in Japan and is accelerating production.

Gilead: The Californian biotech giant initiated clinical trials in March for its antiviral drug remdesivir on patients in the U.S.

Grifols: Spanish pharmaceutical company is working with the FDA and the U.S. Department of Health and Human Services to develop a COVID-19 treatment using the blood plasma of former patients.

Harbour BioMed: Cambridge, Massachusetts biomedical firm announced a collaboration with New Yorks Mount Sinai Health System to develop new human antibodies to treat COVID-19.

Humanigen: Burlingame, California pharma company received emergency FDA approval for compassionate use of its antibody lenzilumab in COVID-19 patients.

I-Mab Biopharma: Shanghai-based biopharma outfit announced it would begin clinical trials of its TJM2 antibody treatment on COVID-19 patients in the United States, with plans to expand to other countries affected by the pandemic.

Innovation Pharmaceuticals: Wakefield, Massachusetts biopharma firm is researching the use of its drug brilacidin part of a category of investigational new drugs called defensin mimetics, which could have antimicrobial effects as both a treatment and a vaccine for COVID-19, in separate efforts with a major U.S. university and with the Department of Health and Human Services.

ISR Immune System Regulation: Swedish immunotherapy firms subsidiary, ISR HBV, is conducting toxicological studies to determine whether its Immunolid ISR50 treatment could be used against COVID-19.

Kamada: Israeli pharmaceutical company is working on an antibody-based treatment for COVID-19 using the blood plasma of patients who recovered from the disease.

Merck KGaA: Darmstadt, Germany-based pharma multinational donated a supply of its multiple sclerosis drug interferon beta-1a to the French National Institute of Health and Medical Research in Paris for clinical trials on COVID-19 patients. The companys North American life sciences arm, MilliporeSigma, is supplying several vaccine efforts with reagents and other essential raw products for vaccine development.

Mesoblast: Australian medical firm is working with authorities in the U.S., Australia, China and Europe to evaluate the use of its remestemcel-L drug to treat COVID-19.

Mylan: Pennsylvania-based pharmaceutical firm restarted production of hydroxychloroquine, a drug used to fight lupus, malaria and arthritis, at its West Virginia factory; the drug is being tested as a treatment for COVID-19 in human trials in New York.

Partner Therapeutics: Lexington, Massachusetts biotech startup began clinical trials of its bone marrow stimulant drug sargramostim on COVID-19 patients at University Hospital Ghent in Belgium.

PharmaMar: Spanish drugmaker is preparing to start clinical trials of its multiple myeloma drug plitidepsin to treat COVID-19 patients at several hospitals in Spain.

Pluristem Therapeutics: Haifa, Israel-based medical company is developing a cell-based therapy to treat COVID-19, announcing on March 30 it had dosed three Israeli patients under a compassionate use program, with plans to enroll more.

Leonard Schleifer.

Regeneron Pharmaceuticals: Westchester, New York biotech outfit, run by billionaires Leonard Schleifer and George Yancopoulos, is conducting clinical trials of its rheumatoid arthritis drug sarilumab, developed with French firm Sanofi, on patients in New York.

Roche: Swiss pharma titan, part-owned by billionaire Maja Oeri, is testing its arthritis drug tocilizumab to treat patients in China and received FDA approval to begin U.S. trials.

Roivant Sciences: Swiss pharma company is working with U.S. authorities to begin trials of its antibody treatment, gimsilumab, on COVID-19 patients.

Synairgen: Southampton, UK-based drugmaker began clinical trials of its SNG001 treatment on COVID-19 patients on March 31.

Takeda: Japanese medical firm is working on hyperimmune therapy using blood plasma from previously infected patients.

Teva Pharmaceuticals: Pharma multinational is ramping up production of hydroxychloroquine, which is being tested as a treatment for COVID-19 in human trials in New York.

Vir Biotechnology: The San Francisco-based firm is collaborating with Biogen and Chinese medical firm WuXi Biologics to manufacture antibodies that could treat the virus; on April 6, British pharma giant GlaxoSmithKline purchased a stake in the company for $250 million, with the goal of collaborating on treatments for COVID-19.

Vaccines:

AJ Vaccines: Danish vaccine developer is working on a COVID-19 vaccine that could hit the market in 2021.

Altimmune: The company is developing a novel intranasal vaccine for the coronavirus, making it one of three firms based in Gaithersburg, Maryland along with Emergent Biosolutions and Novavax thats working on treatments and vaccines for COVID-19.

Arcturus Therapeutics: San Diego-based vaccine maker is developing a COVID-19 vaccine with researchers at the Duke-National University of Singapore medical school in Singapore.

Biocad: Russian drug developer is researching a COVID-19 vaccine, with animal trials scheduled for late April.

Thomas and Andreas Struengmann.

BioNTech: German biotech firm backed by billionaire twins Thomas and Andreas Struengmann is working to develop a coronavirus vaccine in partnership with Pfizer and Fosun Pharma, chaired by billionaire Guo Guangchang.

CanSino Biologics: Tianjin, China-based pharma company isstarting clinical trials for its COVID-19 vaccine, using the vaccine technology deployed to develop the Ebola vaccine.

Codagenix: Melville, New York biotech firm is teaming up with the Serum Institute of India to develop a live-attenuated COVID-19 vaccine, which uses a live but weakened form of the virus.

Dietmar Hopp.

CureVac: German firm, funded by billionaire Dietmar Hopp and the Bill and Melinda Gates Foundation, received $87 million from the European Commission to scale up development of its coronavirus vaccine.

Dyadic: Jupiter, Florida company is collaborating with the Israel Institute for Biological Research on both treatment and a vaccine against COVID-19, using the firms gene expression platform.

Dynavax: Emeryville, California vaccine maker is working with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Queensland to develop a COVID-19 vaccine.

EpiVax: Providence-based immunology firm is working with the University of Georgia and Miramar, Florida biotech outfit Generex on separate COVID-19 vaccine efforts.

ExpreS2ion: Danish biotech company received a grant of nearly $1 million from the European Union to develop a vaccine for COVID-19.

GeoVax: Atlanta-based medical company is collaborating with Wuhan-based BioVax to jointly produce a COVID-19 vaccine.

GlaxoSmithKline: British pharma titan is partnering with CEPI and Chengdu, China-based Clover Pharmaceuticals to use its pandemic vaccine adjuvant platform which boosts the immune response in patients receiving a shot to speed up development of COVID-19 vaccines; on April 6, the company purchased a stake in San Francisco-based Vir Biotechnology for $250 million, with the goal of collaborating on treatments for COVID-19.

Greffex: Houston-based genetic engineering firm is preparing to begin animal trials for its COVID-19 vaccine.

Heat Biologics: North Carolina biopharma company is developing a COVID-19 vaccine with the University of Miami.

iBio: Newark, Delaware biotech upstart is collaborating with Beijing-based CC-Pharming on the rapid development of a COVID-19 vaccine.

Inovio: Plymouth Meeting, Pennsylvania biotech business is the second company to start human trials of a COVID-19 vaccine, announcing on April 6 it would begin testing in Philadelphia and Kansas City; the company also received $11.9 million in funding from the Department of Defense to rapidly produce the vaccine.

Johnson & Johnson: The companys pharma unit, Janssen, will start manufacturing its vaccine developed with the Department of Health and Human Services this month, with human trials set to begin by September and a public rollout hoped for early 2021. The company and the federal government are investing more than $1 billion in the vaccine effort.

Medicago: Quebec City-based biotech company received more than $7 million from the Canadian and Quebec governments to fund development of its COVID-19 vaccine.

Moderna: Massachusetts biotech company, led by billionaire CEO Stphane Bancel, was the first tobegin human trials of its vaccine on March 16 in Seattle and could deploy it to health workers for emergency use by the fall.

Novavax: Maryland-based vaccine maker received $4 million in funding from CEPI to accelerate development of its vaccine candidates, with clinical trials expected in the late spring.

Sanofi: French medical firm is working with the federal government and Massachusetts-based Translate Bio to expedite its coronavirus vaccine, using technology previously used to develop one for SARS.

SK Group: South Korean conglomerates pharmaceutical arm, SK Bioscience, is conducting animal trials of its COVID-19 vaccine.

Sorrento Therapeutics: San Diego-based biotech firm is teaming up with Cambridge, MA gene therapy company SmartPharm Therapeutics to develop a gene-encoded COVID-19 vaccine; its also working with Chinese drugmaker Mabpharm on a fusion protein treatment for the disease.

Takis Biotech: Italian startup with just 25 employees is developing a vaccine with Stony Brook-based Applied DNA Sciences, with plans to begin human trials before the end of the year.

Themis Bioscience: Austrian biotech firm is part of a group, with the Institut Pasteur and the University of Pittsburgh, which received $4.9 million in initial funding from CEPI to build a COVID-19 vaccine modeled on the vaccine for measles.

Tonix Pharmaceuticals: New York-based pharma outfit is researching a potential COVID-19 vaccine based on the virus that causes horsepox.

Vaxart: San Francisco vaccine manufacturer Vaxart is working with Emergent Biosolutions to develop and manufacture an oral vaccine that can be taken as a tablet.

Vaxil: Israeli biotech startup began preclinical trials for its COVID-19 vaccine candidate.

VBI Vaccines: Massachusetts-based vaccine developer is collaborating with the National Research Council of Canada on a pan-coronavirus vaccine, which would target COVID-19 as well as SARS and Middle East respiratory syndrome, or MERS.

Protective Equipment And Sanitizer:

Anheuser-Busch InBev: The worlds largest beer company is making more than one million bottles of hand sanitizer from surplus alcohol at its breweries around the world.

Aria Designs: North Carolina furniture manufacturer received financing from CIT Group to procure millions of N95 surgical masks with its international suppliers.

Giorgio Armani.

Armani: Billionaire Giorgio Armanis luxury fashion brand converted all production at its Italian factories to manufacture single-use medical overalls on March 26.

Bacardi: The Bermuda-based spirits giant converted production at nine production facilities in Mexico, France, England, Italy, Scotland, Puerto Rico and the continental U.S. to make hand sanitizer.

Read this article:
Coronavirus Business Tracker: How The Private Sector Is Fighting The COVID-19 Pandemic - Forbes

Treatment with CytoDyn’s Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients – Associated Press

VANCOUVER, Washington, April 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the three-day effect of leronlimab in eight severely ill COVID-19 patients demonstrated a significant improvement in several important immunologic bio-markers. Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.

The Companys investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The Company recently initiated enrollment in a Phase 2 trial for leronlimab treatment of COVID-19 patients with mild-to-moderate indications and under the same IND, is now proceeding with its second COVID-19 clinical, a Phase 2b/3 trial for the treatment of critically ill patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, We are very pleased with our most recent laboratory data for patients treated with leronlimab for COVID-19 infection. We continue to see increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function and mitigation of the cytokine storm. This is consistent with prior laboratory results in the first four patients treated for COVID-19 with leronlimab.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, As leronlimab continues to provide hope for many patients, our management team is focused to ensure we can distribute the drug across the country in a timely fashion. These results, although anecdotal, appear to be very promising. We are now initiating enrollment for two clinical trials, first trial is a Phase 2 for mild-to-moderate and second trial is a Phase 2b/3 for a severely ill population.

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

See the original post here:
Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients - Associated Press