BioSig Subsidiary ViralClear Submits Application for Vicromax™ Through FDA’s Coronavirus Treatment Acceleration Program (CTAP) to Seek Acceleration of its Planned Clinical Trials
Westport, CT, April 21, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) today announced that on April 16, 2020 its subsidiary ViralClear Pharmaceuticals, Inc. submitted an application for Vicromax(tm) (merimepodib, or MMPD) through the FDA’s Coronavirus Treatment Acceleration Program (CTAP) to administer the drug to hospitalized patients with COVID-19.
On March 31, 2020, the FDA created the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program for possible therapies, using every available method to move new treatments to patients as quickly as possible. The FDA continues to support clinical trials that are testing new treatments for COVID so that they gain valuable knowledge about their safety and effectiveness.
“We believe that submitting an application through CTAP could help accelerate the momentum for ViralClear as it moves closer to Phase II trials given the FDA’s initiative to bring coronavirus treatments to the market as fast as possible,” stated Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “We believe strongly in Vicromax(tm) and the potential it has to possibly help patients that are suffering from COVID-19.”
Vicromax(tm) is an anti-viral candidate merimepodib that targets RNA-dependent polymerases. The molecule has shown activity against a broad spectrum of RNA viruses and has demonstrated satisfactory safety data from over 300 patients treated for hepatitis C. Recently, ViralClear published its first pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. A manuscript titled “The IMPDH inhibitor merimepodib suppresses SARS-COV-2 replications” was authored by Natalya Bukreyeva, Emily K. Mantlo, Rachel A. Sattler, Cheng Huang, Slobodan Paessler, DVM, Ph.D. of the UTMB Galveston National Laboratory, and Jerome Zeldis, M.D., Ph.D. of ViralClear. In vitro studies referenced in the manuscript demonstrated that merimepodib decreased viral production by over 98%.
To learn more about Coronavirus Treatment Acceleration Program (CTAP), please use the following link: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).
The Company’s first product, PURE EP(tm) System is a computerized system 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.
About ViralClear
BioSig’s subsidiary ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical to treat COVID-19. Vicromax(tm) is intended to be an orally administered, broad-spectrum anti-viral agent that has demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. The product candidate has completed Phase I and three Phase II trials in other indications.
Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133
Released April 21, 2020
