ViralClear Opens Enrollment with First Patient Dosing in Phase II Human Trial of Anti-Viral MMPD Oral Solution for Treatment ...
June 17 2020 - 7:55AM
BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the
“Company”) and its subsidiary, ViralClear Pharmaceuticals, Inc.,
today announced that it has commenced patient enrollment with the
dosing of the first patient in its Phase II trial for merimepodib,
a broad-spectrum, orally administered anti-viral drug candidate for
the treatment of COVID-19 in adult patients. Confirmed trial sites
include 3 sites from the Mayo Clinic including Rochester, MN,
Jacksonville, FL, Phoenix, AZ and St. David’s South Austin Medical
Center in Austin, TX and the Atlantic Health System -Overlook
Hospital in Summit, NJ and Morristown Medical Center in Morristown,
NJ.
The Phase II trial is titled “A Phase 2, Randomized,
Double-Blind, Placebo-Controlled Study of the Efficacy and Safety
of Oral Merimepodib in Combination with Intravenous Remdesivir in
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 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 antiviral 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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