Palm Beach, FL – March 31, 2020 – The World Health Organization has urged people and nations to avoid spreading the pathogen in the current global health crisis while the search for treatments continues at a its frenzied pace, but even at their most effective – and draconian – containment strategies have only slowed the spread of this respiratory disease. With the World Health Organization finally declaring a pandemic, all eyes have turned to the prospect of a vaccine, because only a vaccine can prevent people from getting sick. According to The Guardian, about 35 companies and academic institutions are racing to create such a vaccine, and Human trials will begin imminently – but even if they go well and a cure is found, there are many barriers before global immunization is feasible. This unprecedented speed is thanks in large part to early Chinese efforts to sequence the genetic material of the virus. China shared that sequence in early January, allowing research groups around the world to grow the live virus and study how it invades human cells and makes people sick. Active healthcare stocks in news today include: BioSig Technologies, Inc. (NASDAQ: BSGM), Gilead Sciences, Inc. (NASDAQ: GILD), CytoDyn Inc. (OTCQB: CYDY), Novavax, Inc. (NASDAQ: NVAX), Roche Holding AG (OTCQX: RHHBY).
The Guardian reported that there is another reason for the head start. “Though nobody could have predicted that the next infectious disease to threaten the globe would be caused by a coronavirus – flu is generally considered to pose the greatest pandemic risk – vaccinologists had hedged their bets by working on “prototype” pathogens. “The speed with which we have [produced these candidates] builds very much on the investment in understanding how to develop vaccines for other coronaviruses,” says Richard Hatchett, CEO of the Oslo-based nonprofit the Coalition for Epidemic Preparedness Innovations(Cepi), which is leading efforts to finance and coordinate Covid-19 vaccine development.
Clinical trials, an essential precursor to regulatory approval, usually take place in three phases. The first, involving a few dozen healthy volunteers, tests the vaccine for safety, monitoring for adverse effects. The second, involving several hundred people, usually in a part of the world affected by the disease, looks at how effective the vaccine is, and the third does the same in several thousand people. But there’s a high level of attrition as experimental vaccines pass through these phases. “Not all horses that leave the starting gate will finish the race,” says Bruce Gellin, who runs the global immunization program for the Washington DC-based nonprofit, the Sabin Vaccine Institute.
BioSig Technologies, Inc. (NASDAQ:BSGM) BREAKING NEWS – Jerome Zeldis, M.D., Ph.D, Appointed as Executive Chair of ViralClear Pharmaceuticals, Inc. – BioSig Technologies, a medical technology company commercializing a proprietary biomedical signal processing platform, today announced that it appointed Jerome Zeldis, M.D., Ph.D as Executive Chair of ViralClear Pharmaceuticals, Inc., a new division within its majority-owned subsidiary NeuroClear Technologies, Inc., which recently acquired the rights to develop a novel pharmaceutical to treat Coronavirus Disease 2019 (COVID-19).
Jerome (“Jerry”) Zeldis, M.D., Ph.D brings extensive life sciences experience gained primarily through his career at Celgene, Inc. He previously served as Chief Executive Officer of Celgene Global Health and Chief Medical Officer of Celgene Corporation, a publicly traded, fully integrated biopharmaceutical company, where he was employed for nearly 20 years, starting in 1997. Celgene Corporation was recently acquired by Bristol Myers-Squibb (NYSE:BMY]. Dr. Zeldis currently serves as a Director of BioSig.
“From the moment we learned that we may have a possible solution to help address this global pandemic, we have been working tirelessly to bring this pharmaceutical to patients,” commented Dr. Zeldis. “I look forward to pursuing development of Vicromax(tm) and contributing my knowledge and expertise to this important initiative.”
From 2016 to recently, Dr. Zeldis served as Chief Medical Officer and President of Clinical Research, Medical Affairs Drug Safety, Quality, and Regulatory at Sorrento Therapeutics, Inc. He attended Brown University for an AB, MS, followed by Yale University for an M Phil, MD, PhD in Molecular Biophysics and Biochemistry. Dr. Zeldis trained in Internal Medicine at the UCLA Center for the Health Sciences and in Gastroenterology at the Massachusetts General Hospital and Harvard Medical School. He was Assistant Professor of Medicine at the Harvard Medical School, Associate Professor of Medicine at University of California, Davis, Clinical Associate Professor of Medicine at Cornell Medical School and Professor of Clinical Medicine at the Robert Wood Johnson Medical School in New Brunswick, New Jersey. Dr. Zeldis is a named inventor on 43 US patents, has published 122 peer reviewed articles and 24 reviews, book chapters and editorials.
In a preliminary internal review, the orally administered, broad-spectrum anti-viral agent Vicromax(tm) demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. In this analysis, Vicromax(tm) was added to a tissue culture assay for SARS-CO-2 coronavirus (the causative agent for COVID-19) and an anti-viral effect was observed, which led to a reduction of over 90% of infectious viruses. The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials. The product candidate already completed Phase I and three Phase II clinical trials involving over 134 subjects for indications other than COVID-19, and underwent extensive animal testing and human clinical experience. The Company expects that Vicromax(tm) might be used alone or in a combination with other anti-viral agents or immune modulators. Read this entire press release and more news for BSGM at: https://financialnewsmedia.com/news-bsgm
In other healthcare news of note:
CytoDyn Inc. (OTCQB: CYDY) recently announced that an additional three critically ill COVID-19 patients have been treated with leronlimab. These additional patients increase the total to 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug (EIND) granted by the U.S. Food and Drug Administration (FDA).
The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in these patients. The laboratory evaluation of the first four patients treated with leronlimab revealed that the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm (including IL-6 and TNF alpha) were much improved. The results of the three additional patients are expected this week.
Roche Holding AG (OTCQX: RHHBY) recently provided an update on the various actions the company is taking to address the COVID-19 pandemic.
On March 19, 2020, Roche confirmed initiation of a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). The study, COVACTA, will evaluate the safety and efficacy of intravenous Actemra®/RoActemra® (tocilizumab) on top of standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo on top of standard of care. This is the first global study of Actemra/RoActemra in this setting. In addition to the Roche trial, Roche is also carefully following independently-led clinical trials, on multiple medicines including Actemra, that are taking place around the world.
Novavax, Inc. (NASDAQ: NVAX) recently announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant, in adults aged 65 and older. Using the Food and Drug Administration’s (FDA) criteria for accelerated approval of seasonal influenza vaccines, the trial evaluated the immunogenicity and safety of NanoFlu compared to Fluzone® Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.
The trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to Fluzone Quadrivalent using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. NanoFlu achieved the primary endpoints, both GMT and SCR, for all four strains included in the vaccine. NanoFlu was well-tolerated and had a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs).
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced data from clinical and preclinical studies exploring the use of GS-6207, an investigational, novel, first-in-class inhibitor of HIV-1 capsid function, as a potential long-acting therapy for people living with HIV. Results from a Phase 1b proof-of-concept study of a subcutaneous formulation showed antiviral activity with GS-6207 through the last day of monotherapy, Day 10, with significantly greater reductions in HIV-1 RNA versus placebo across all treatment groups (20 to 750 mg; all p<0.0001). These data were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2020 in Boston.
Additional data presented at CROI provided further information on the potential utility of GS-6207 that support further development of the compound. Phase 1 data in healthy volunteers evaluating an oral tablet formulation found GS-6207 to be generally safe and well-tolerated with a pharmacokinetic profile supporting once a week administration without regard to food. Results from a preclinical study evaluating the impact of resistance mutations on the in vitro antiviral activity of GS-6207 were also presented. In this in vitro study, GS-6207 was not affected by mutations at the gag cleavage sites or by mutations associated with resistance to the four main classes of antiretroviral agents.
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