BioSig Subsidiary ViralClear Submits Application for Vicromax™ Through FDA’s Coronavirus Treatment Acceleration Program (...
April 21 2020 - 10:15AM
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 ViralClearBioSig’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 StatementsThis 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
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