BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the
“Company”) and its subsidiary, ViralClear Pharmaceuticals, Inc.,
today announced that it has signed an agreement with Catalent, the
leading global provider of advanced delivery technologies,
development, and manufacturing solutions for drugs, biologics, cell
and gene therapies, and consumer health products, to work on the
development of a potential treatment for adults with advanced
Coronavirus Disease 2019 (COVID-19).
Under the terms of the agreement, Catalent will
be developing two oral dosage forms of ViralClear’s broad-spectrum
anti-viral agent, merimepodib: a solution and a solid oral dosage
form.
ViralClear is undertaking research to
investigate the potential of Merimepodib to fight the SARS-CoV-2
virus, either as a standalone treatment, or in combination with
other anti-viral agents or immune modulators.
“We are pleased to be working with Catalent that
has already manufactured clinical trial materials of our
merimepodib oral solution for the current Phase 2 clinical trial
and is performing further product development on liquid-filled oral
formulations,” commented Steve King, Chief Operating Officer of
ViralClear. He continued, “ViralClear is committed to using
US-based contract development and manufacturing organizations for
the development and commercialization of merimepodib.”
Catalent will work on the program at its St.
Petersburg, Florida, facility, manufacturing oral solution for
clinical studies, as well as undertaking feasibility studies on
other liquid-filled oral formulations. Catalent’s 453,000-square
foot facility at St. Petersburg is its primary softgel development
and manufacturing facility in the U.S., with a capacity of 18
billion capsules per year.
“Finding treatments for the pandemic we are
faced with is a global priority, and, as a world leader in softgel
development and manufacturing, Catalent is ideally suited to work
on this program with ViralClear,” commented Dr. Aris Gennadios,
President, Softgel & Oral Technologies. “Our expertise and more
than 85 years of experience in lipid-based formulation will
facilitate rapid clinical manufacturing and provide drug product
that can be tested against the threat the virus poses as soon as
possible.”
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, Inc. and Merimepodib
(MMPD) BioSig Technologies, Inc.’s (Nasdaq: BSGM)
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.
About Catalent Catalent is the leading global
provider of advanced delivery technologies, development, and
manufacturing solutions for drugs, biologics, cell and gene
therapies, and consumer health products. With over 85 years serving
the industry, Catalent has proven expertise in bringing more
customer products to market faster, enhancing product performance
and ensuring reliable global clinical and commercial product
supply. Catalent employs over 13,500 people, including over 2,400
scientists and technicians, at more than 40 facilities, and in
fiscal year 2019 generated over $2.5 billion in annual revenue.
Catalent is headquartered in Somerset, New Jersey. For more
information, visit http://www.catalent.com.
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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