Gencaro cardiovascular effect on patients with atrial
fibrillation paper published in European Journal of Heart Failure.
SOURCE: ARCA biopharma, www.arcabiopharma.com
Full press release
follows.
BROOMFIELD, Colo.--(BUSINESS WIRE)—Dec. 12, 2012 -- ARCA
biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing
genetically-targeted therapies for atrial fibrillation and other cardiovascular
diseases, today announced that the paper "Effect of Bucindolol (Gencaro)
on Heart Failure Outcomes and Heart Rate Response in Patients with Reduced
Ejection Fraction Heart Failure and Atrial Fibrillation” was published in the
European Journal of Heart Failure (www.escardio.org/journals/european-journal-heart-failure),
a publication of the Heart Failure Association of the European Society of Cardiology.
The paper discusses post-hoc analyses of data from the Phase 3
clinical study of Gencaro in heart failure, known as the Beta-Blocker
Evaluation of Survival Trial (BEST), which was sponsored by the National Heart,
Lung and Blood Institute of the National Institutes of Health, and the
Cooperative Studies Program of the Department of Veterans Affairs. These data
demonstrate that patients with established atrial fibrillation (AF) in BEST who
received Gencaro had improvements in heart failure clinical endpoints. Compared
to placebo, the effects of Gencaro on improving heart failure clinical
endpoints in the 303 patients in BEST with established AF were generally
similar to the effects of Gencaro on these endpoints in the 2,176 patients in
BEST with normal sinus rhythm.
The data also demonstrate that Gencaro made it more likely for
patients with established AF to achieve ventricular rate control, and that
Gencaro improved cardiovascular clinical endpoints for those AF patients who
did achieve rate control. 67% of AF patients who received Gencaro achieved
ventricular response rate control, defined as a resting heart rate of less than
or equal to 80 beats per minute without symptomatic bradycardia (p < 0.005).
In AF patients who achieved ventricular response rate control, Gencaro produced
a 39% reduction (p = 0.025) in cardiovascular mortality/cardiovascular
hospitalizations. In addition, Gencaro also improved cardiovascular clinical
endpoints for those AF patients possessing the genotype which ARCA believes is
most favorable for Gencaro response. In a substudy of 1,040 patients in BEST in
which patient genotypes were analyzed, Gencaro was associated with a 72%
decrease (p = 0.039) in cardiovascular mortality/cardiovascular
hospitalizations in those 52 AF patients in the substudy with the beta-1 389
arginine homozygous genotype. ARCA believes that this genotype predicts a
favorable response to Gencaro, and is estimated to be present in about 50% of
the population in the U.S. These data are in contrast to the data reported for
studies of other beta-blockers, including carvedilol, in which AF patients with
the beta-1 389 arginine homozygous genotype who received those drugs exhibited
evidence of resistance to heart rate reduction.
Christopher O'Connor, MD, Professor of Medicine and
Cardiologist, Duke University Medical Center, and a co-author of the paper
commented, "In placebo controlled trials of patients with heart failure
and reduced left ventricular ejection fraction (HFREF) who also have permanent
AF, currently approved beta blockers have not shown benefit by improving
clinical endpoints. In this study, Gencaro exhibited evidence of
efficacy against clinical endpoints in patients with HFREF and AF. In addition,
this efficacy appears to be pharmacogenetically enhanced in patients with the
beta-1 389 arginine homozygous genotype, and rate control was also effective in
this genotype. This evidence of rate control by Gencaro in this genotype is
important because it has been reported that other beta-blockers do not provide
adequate rate control in AF patients with this genotype."
Michael Bristow, MD, PhD, President and CEO of ARCA biopharma
and Professor of Medicine (Cardiology) at the University of Colorado Anschutz
Medical Campus, and a senior author of the paper added, "These data from
the BEST study suggest that Gencaro may be safe and effective in patients with
permanent AF. ARCA would be able to further test this hypothesis in its
proposed trial of Gencaro in AF prevention."
ARCA has been granted patents in the U.S., Europe, and other
jurisdictions for methods of identifying and treating patients with the beta-1
389 arginine homozygous genotype. The Company plans to conduct a Phase 3
clinical trial to evaluate Gencaro as a potential treatment for the prevention
of AF in patients with this genotype, subject to receiving the necessary
funding.
About ARCA biopharma
ARCA biopharma 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 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 the Laboratory Corporation of America
(LabCorp), under which LabCorp has developed a companion genetic test for
Gencaro. For more information please visit www.arcabiopharma.com.
Safe Harbor Statement
This press release and the associated presentation may contain
"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 ability of genetic variations
to predict individual patient response to Gencaro, Gencaro’s potential to treat
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, 2011 and subsequent filings. The Company disclaims
any intent or obligation to update these forward-looking statements.
Contacts
ARCA biopharma, Inc.
Christopher D. Ozeroff
Senior Vice
President and General Counsel
720-940-2100
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