ARCA biopharma Announces IND Submission to US FDA for Gencaro for the
Treatment of Atrial Fibrillation
GENETIC-AF Trial Data Safety Monitoring Board Established
WESTMINSTER, Colo. -- October 29, 2013
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing
genetically targeted therapies for cardiovascular diseases, today announced
that it has submitted an Investigational New Drug (IND) application to the
U.S. Food and Drug Administration (FDA) for the GENETIC-AF clinical trial of
Gencaro (bucindolol hydrochloride), a pharmacologically unique beta-blocker
and mild vasodilator being developed for atrial fibrillation (AF). ARCA has
identified common genetic variations that it believes predict individual
patient response to Gencaro, giving it the potential to be the first
genetically-targeted AF prevention treatment.
The Data Safety Monitoring Board (DSMB) for the GENETIC-AF trial has been
established. It is comprised of experts in the fields of cardiology,
electrophysiology and statistical analysis, particularly in clinical
GENETIC-AF Clinical Trial
GENETIC-AF is planned as a Phase 2B/3, multi-center, randomized, double-blind
clinical trial comparing Gencaro to Toprol XL for prevention of AF in patients
with heart failure and reduced left ventricular ejection fraction (HFREF).
ARCA plans to enroll only patients with the genetic variant of the beta-1
cardiac receptor which the Company believes responds most favorably to
Gencaro. GENETIC-AF has an adaptive design, under which the Company plans to
initiate it as a Phase 2B study in approximately 200 patients and then,
depending on the results of an interim analysis by the trial Data Safety
Monitoring Board (DSMB), expand the trial to a Phase 3 study by enrolling an
estimated additional 420 patients. The Company anticipates that patient
enrollment in GENETIC-AF will begin in the first quarter of 2014.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies for
cardiovascular diseases. The Company's lead product candidate, Gencaro^TM
(bucindolol hydrochloride), is an investigational, pharmacologically unique
beta-blocker and mild vasodilator being developed for atrial fibrillation.
ARCA has identified common genetic variations that it believes predict
individual patient response to Gencaro, giving it the potential to be the
first 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,
potential timing for patient enrollment in the GENETIC-AF trial, the
sufficiency of the Company’s capital to support its operations, 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, the role of AF burden in diagnosis and
treatment of 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, 2012, and subsequent filings. The Company
disclaims any intent or obligation to update these forward-looking statements.
Derek Cole, 720-940-2163
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