ARCA biopharma Announces Patent Issuance for Methods and Compositions of S-isomer Formulation of Gencaro
February 04 2015 - 8:30AM
Business Wire
Patent Includes Methods for Treating
Multiple Cardiovascular Disease Indications
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically targeted therapies for cardiovascular
diseases, today announced that the U.S. Patent and Trademark Office
(USPTO) has issued a patent on methods and compositions of the
S-isomer formulation of GencaroTM (bucindolol hydrochloride). The
patent (USP# 8946284), entitled “Methods and Compositions involving
(S)-Bucindolol,” provides intellectual property protection in the
United States for the use of S-isomer Gencaro (Gencaro
substantially free of its R-stereoisomer) as a potential treatment
for right ventricular heart failure, congestive heart failure,
hypertension, angina, myocardial infarction, cardiac arrhythmia,
mitral valve prolapse, hypertrophic obstructive cardiomyopathy, or
acute dissecting aortic aneurysm.
“We are pleased with the USPTO’s issuance of this patent, which
we believe broadens our intellectual property protection around
Gencaro in multiple important cardiovascular disease indications
which impact large patient populations globally,” said Michael R.
Bristow, President and Chief Executive Officer of ARCA. “This
patent is a result of ARCA’s continued focus on innovation in
cardiovascular drug development. The S-isomer of Gencaro contains
the high affinity beta-1 and beta-2 receptor-blocking action as
well as nitric oxide generating activity. In GENETIC-AF, our
on-going Phase 2B/3 clinical trial, we are evaluating racemic
(contains both S and R isomers) Gencaro as a potential treatment
for the prevention of atrial fibrillation in a pharmacogenetically
defined heart failure population at high risk of developing
recurrent atrial fibrillation.”
About ARCA biopharma
ARCA is dedicated to developing genetically-targeted therapies
for cardiovascular diseases. The Company's lead product candidate,
GencaroTM (bucindolol hydrochloride), is an investigational,
pharmacologically unique beta-blocker and mild vasodilator being
evaluated as a potential treatment for atrial fibrillation in the
Phase 2B/3 GENETIC-AF clinical trial, which is enrolling patients
in the United States and Canada. ARCA has identified common genetic
variations that it believes predict individual patient response to
Gencaro, giving it the potential to be the first approved
genetically-targeted atrial fibrillation prevention treatment. ARCA
has a collaboration with Medtronic, Inc. for support of the
GENETIC-AF trial. For more information please visit
www.arcabiopharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements" for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. These statements include, but are
not limited to, statements regarding, the potential for S-isomer
Gencaro to possibly be a treatment for several different
cardiovascular indications, the potential for genetic variations to
predict individual patient response to Gencaro, Gencaro’s potential
to treat atrial fibrillation, future treatment options for patients
with atrial fibrillation, and the potential for Gencaro to be the
first genetically-targeted atrial fibrillation prevention
treatment. Such statements are based on management's current
expectations and involve risks and uncertainties. Actual results
and performance could differ materially from those projected in the
forward-looking statements as a result of many factors, including,
without limitation, the risks and uncertainties associated with:
the Company's financial resources and whether they will be
sufficient to meet the Company's business objectives and
operational requirements; results of earlier clinical trials may
not be confirmed in future trials, the protection and market
exclusivity provided by the Company’s intellectual property; risks
related to the drug discovery and the regulatory approval process;
and, the impact of competitive products and technological changes.
These and other factors are identified and described in more detail
in ARCA’s filings with the SEC, including without limitation the
Company’s annual report on Form 10-K for the year ended December
31, 2013, and subsequent filings. The Company disclaims any intent
or obligation to update these forward-looking statements.
Investor & Media Contact:ARCA biopharma, Inc.Derek
Cole, 720-940-2163derek.cole@arcabiopharma.com
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