BioSig Technologies Inc’s (NASDAQ:BSGM) subsidiary ViralClear Pharmaceuticals Inc has formed its Scientific Advisory Board (SAB) with two industry veterans experienced as both regulators and corporate executives.
In a statement Monday, the company said the SAB will review all aspects of drug discovery and development and will advise its parent on its mission to control emerging infections and viral diseases of special interest, including the coronavirus (COVID-19).
ViralClear’s announcement comes as it begins enrolling patients for its Phase 2 trial of merimepodib -- and orally administered drug that has demonstrated broad-spectrum in-vitro antiviral activity, including strong activity against SARS-CoV-2 (the virus that causes the COVID-19 disease) in cell cultures.
READ: BioSig and subsidiary ViralClear enroll patients at four sites for coronavirus trial of merimepodib
Initially, the external advisors of the SAB will consist of Robin Robinson, the former Head of Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Department of Health and Human Services, and Dr J Paul Waymack, formerly of the US Food and Drug Administration.
BioSig said Robinson, who serves currently as the chief scientific officer for RenovaCare Inc (OCTMKTS:RCAR) brings extensive experience in the development of vaccines and pharmaceutical products from discovery and early development through advanced development towards regulatory approval.
For example, BigSig noted that 38 products supported by BARDA during his tenure (2004-2016) were approved, licensed, or cleared by the FDA.
Dr Waymack is a former FDA medical officer, a former Associate Professor of Medicine at the New Jersey School of Medicine and Dentistry, and the former chairman of the board of directors and chief medical officer of Israel-based Kitov Pharma.
BioSig noted that Dr Waymack has had multiple patents granted and over 100 scientific publications in medical journals primarily related to the fields of immunology and infections. During his career, he has also successfully brought multiple drugs and medical devices through clinical development to FDA approval.
“The quality of the SAB members reflects the interest in ViralClear’s assets, including merimepodib, for addressing the current COVID-19 pandemic and other serious viral infectious diseases that cause major economic disruptions,” said Dr Jerome Zeldis, the acting chief medical officer and head of ViralClear. “We are fortunate to be able to tap into their collective wisdom.”
Dr. Waymack commented: “As society now faces its greatest biological threat in over a century, it is critical that we develop new therapies to treat this pandemic. Based upon in vitro data, merimepodib appears to offer significant potential in treating COVID-19 patients. I am therefore honored to be able to participate in its development and to serve on ViralClear’s scientific advisory board. I look forward to working with the talented individuals serving on this board and with the company’s physicians and scientists.”
BioSig, based in Westport, Connecticut, said it is expected that other experienced scientists and clinicians will join the SAB over the next three to six months.
Aside from the development of merimepodib, the company is also commercializing a proprietary biomedical processing platform designed to improve signal fidelity and uncover the full range of electrocardiogram (ECG) and intracardiac signals.
Its first product, PURE EP System, is intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.
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