BioSig Subsidiary ViralClear Submits Investigational New Drug Application to the FDA for Phase II Clinical Trials for Merimep...
April 24 2020 - 9:25AM
- In vitro studies demonstrated decrease of viral
production by over 98%
- Upon approval, clinical trial to be conducted at Mayo
Clinic under the leadership of Andrew D. Badley, M.D., Professor
and Chair of Department of Molecular Medicine and
the Enterprise Chair of COVID-19 Task Force
BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the
“Company”) today announced that its subsidiary ViralClear
Pharmaceuticals, Inc. submitted an Investigational New Drug (IND)
Application to the Food and Drug Administration (FDA) for its Phase
II clinical trial with Merimepodib as a treatment for COVID-19.
The study will be a randomized, placebo-controlled trial to
evaluate the efficacy and safety of Merimepodib in patients with
COVID-19. The placebo-controlled Phase II clinical trial calls for
20 planned patients from three Mayo Clinic sites: Rochester, MN;
Scottsdale, AZ; and Jacksonville, FL. Data from the Phase II trial
is expected within three months of the commencement of the trial.
Upon approval from the FDA to commence, the Phase II clinical trial
will be conducted at Mayo Clinic under the leadership of Andrew D.
Badley, M.D., Professor and Chair of Department of Molecular
Medicine and the Enterprise Chair of COVID-19 Task Force.
“We are very pleased that the Mayo Clinic IRB Committee has
approved our protocol,” commented Jerome Zeldis, M.D., Ph.D.,
Executive Chairman of ViralClear Pharmaceuticals, Inc. “We are now
waiting for the submitted IND to be filed before we can commence
the trial”.
“Our internal team and our colleagues at Mayo Clinic have moved
with focus and speed over the past few weeks. We have been
gratified by the professionalism and commitment that has been
brought to this critical work,“ commented Nick Spring, CEO of
ViralClear Pharmaceuticals, Inc.
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 advanced COVID-19. Merimepodib is a broad-spectrum
anti-viral agent that has demonstrated strong activity against the
COVID-19 virus in cell cultures in laboratory testing. ViralClear
plans to initiate a multi-center, phase 2, randomized,
double-blind, placebo-controlled study of the efficacy and safety
of merimepodib administered orally every eight hours for 10 days in
adult patients with advanced COVID-19 upon FDA clearance to
proceed. Merimepodib has been studied in twelve clinical trials
prior to this study, including five trials in patients with
hepatitis C (one phase 1b, one phase 2, two phase 2a, and one phase
2b), one trial in patients with psoriasis (phase 2), and six trials
in healthy volunteers (all phase 1).
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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