BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the
“Company”) and its majority owned subsidiary, ViralClear
Pharmaceuticals, Inc., today announced that it has expanded its
patient enrollment centers to include St. David’s South Austin
Medical Center in Austin. The hospital is part of St. David’s
HealthCare, one of the largest healthcare systems in Texas. The
Company intends to commence its Phase II clinical trial for
merimepodib, its broad-spectrum oral anti-viral candidate for the
treatment of COVID-19 in adult patients in the coming weeks.
The clinical trial team consists of Brian Metzger, M.D., MPH,
Medical Director of Infectious Diseases at St. David's Medical
Center, who is is the principal investigator, as well as
Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., Cardiac
Electrophysiologist and Executive Medical Director of the Texas
Cardiac Arrhythmia Institute at St. David’s Medical Center, and
Matthew Robinson, M.D., Medical Director of Infectious Diseases at
St. David's South Austin Medical Center, who are co-investigators
for the study.
“The safety and quality of treatment for our patients is our top
priority, and we take numerous measures to ensure the highest level
of care. As such, we remain steadfast in the pursuit against the
coronavirus, and we look forward to working with ViralClear on the
Phase II trial of its antiviral candidate as a potential solution
against this virus,” commented Dr. Metzger.
“Adding St. David’s South Austin Medical Center as an
investigating center in the ViralClear clinical trial with
merimepodib has the potential to allow the Company to accelerate
clinical development and generate results from a more diverse
population of patients," commented Kenneth L. Londoner, Chairman
and CEO of BioSig Technologies, Inc. and Director at ViralClear
Pharmaceuticals, Inc. “We have been innovating with Dr. Andrea
Natale since we started BioSig over eleven years ago. His guidance
has been vital to us through all stages of product development and
in the early commercialization of our PURE EP(tm) System. We are
thankful for Dr. Natale’s leadership during these unprecedented
times and look forward to collaborating with the whole St. David’s
team on this important mission.”
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 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 St. David’s HealthCareSt.
David’s HealthCare includes seven of the area’s leading
hospitals and is one of the largest health systems in Texas. The
organization has been recognized with a Malcolm Baldrige
National Quality Award—the nation’s highest presidential honor for
performance excellence. St. David’s HealthCare is the
third-largest private employer in the Austin area, with more than
10,600 colleagues across 132 sites of care.
St. David’s HealthCare is a unique partnership between hospital
management company HCA Healthcare and two local non-profits—St.
David’s Foundation and Georgetown Health Foundation. The
proceeds from the operations of the hospitals fund the foundations,
which, in turn, invest those dollars back into the community. Since
the inception of St. David’s HealthCare in 1996, more than $535
million has been given back to the community to improve the health
and healthcare of Central Texans.
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 Viral Clear 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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