Phase II Human Trial of ViralClear's Anti-Viral for SARS-CoV-2 Coronavirus Underway at 4 Key Trial Sites
July 13 2020 - 1:42PM
BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the
"Company") and its subsidiary, ViralClear Pharmaceuticals, Inc.,
today announced the enrollment of adult patients for its Phase II
trial for merimepodib, a broad-spectrum, orally administered
antiviral drug candidate for the treatment of COVID-19, at four key
trial sites. The trial sites are located in Austin, TX, Rochester,
MN, Jacksonville, FL, and Scottsdale, AZ.
Merimepodib is intended to be orally administered and has
demonstrated broad-spectrum in-vitro antiviral activity, including
strong activity against SARS-CoV-2 in cell cultures.
"Three of our four trial sites where our partners are enrolling
patients are in the recognized hot spots of Texas, Arizona, and
Florida. The patients in this trial are hospitalized and requiring
oxygen; therefore, providing effective treatment is of the utmost
importance to all," commented Kenneth L. Londoner, Chairman and CEO
of BioSig Technologies, Inc., the majority shareholder of
ViralClear Pharmaceuticals, Inc. "Arizona, Florida, and Texas
are unfortunately seeing spikes in COVID-19 cases resulting in
hospitals reaching near capacity. We would like to thank our
clinical partners for the steady progress with the trial and expect
to report the trial data later this summer".
The Phase II randomized, double-blind, placebo-controlled study
is designed to enroll adult patients with advanced Coronavirus
Disease 2019 (COVID-19). A description of this clinical trial can
be accessed via www.clinicaltrials.gov.
Preclinical in vitro laboratory studies performed by
the Galveston National Laboratory at The University of Texas
Medical Branch demonstrated that merimepodib, provided in
combination with remdesivir, showed a reduction in SARS-CoV-2
replication to undetectable levels. Peer-reviewed publication of
these findings can be found at F1000
Research: https://f1000research.com/articles/9-361
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 Pharmaceuticals and Merimepodib
(MMPD)BioSig's subsidiary, ViralClear Pharmaceuticals,
Inc., is seeking to develop a novel pharmaceutical called
merimepodib to treat patients with COVID-19. Merimepodib is
intended to be orally administered and has demonstrated
broad-spectrum in vitro anti-viral activity, including strong
activity against SARS-CoV-2 in cell cultures. Merimepodib was
previously in development as a treatment for chronic hepatitis C
and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with
12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400
subjects and patients and an extensive preclinical safety package
was completed. A manuscript titled, "The IMPDH inhibitor
merimepodib provided in combination with the adenosine analogue
remdesivir reduces SARS-CoV-2 replication to undetectable levels in
vitro", was submitted to an online peer-reviewed life sciences
journal. This manuscript is authored by Natalya Bukreyeva, Rachel
A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and
Slobodan Paessler of the UTMB Galveston National Laboratory and Dr.
Jerome Zeldis of ViralClear Pharmaceuticals, Inc. ("ViralClear") as
a corresponding author. This article highlights pre-clinical data
generated under contract with Galveston National Laboratory at The
University of Texas Medical Branch.
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
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