Gencaro™ Potential Efficacy Preventing Atrial Flutter in Heart Failure Paper to Be Presented at 2015 HFSA Annual Scientific...
September 09 2015 - 9:00AM
Business Wire
The Paper, Which Describes Pharmacogenetic
Enhancement of Effectiveness for Prevention of Atrial Flutter, Was
Also Published in the Journal of Cardiac Failure
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular
diseases, today announced that the paper “Bucindolol Prevents
Atrial Flutter via the Beta-1 389 Arg/Gly Adrenergic Receptor
Polymorphism” will be presented at the 19th Annual Scientific
Meeting of the Heart Failure Society of America (HFSA) to be held
in Washington, D.C. September 26-29, 2015. The paper was recently
published in the Journal of Cardiac Failure
[http://www.onlinejcf.com/article/S1071-9164(15)00366-8/fulltext],
the official journal of the Heart Failure Society of America and
the Japanese Heart Failure Society. The lead author on the paper is
cardiologist-electrophysiologist Ryan G. Aleong of the University
of Colorado, Anschutz Medical Campus, and a co-author on the paper
is Dr. Michael R. Bristow, the Company’s Chief Executive
Officer.
Based on prior data from the Beta-Blocker Evaluation of Survival
Trial (BEST) which suggested that Gencaro (bucindolol
hydrochloride) decreased incident atrial fibrillation (AF) in
patients with heart failure with reduced left ventricular ejection
fraction (HFREF), the authors sought to investigate whether
bucindolol prevented atrial flutter (AFL) to the same degree as AF
in BEST. The author’s retrospective analysis was performed on data
from BEST, which enrolled 2,708 NYHA class III or IV patients and
included a 1,040 patient DNA substudy that genotyped patients for
the β1 -AR 389 Arg/Gly polymorphism.
The author’s results indicated that in BEST there were 17
patients with AFL and 303 patients with AF on their
pre-randomization baseline electrocardiogram (ECG). In patients
with baseline AFL, bucindolol was associated with a higher rate of
reversion to sinus rhythm compared to placebo (bucindolol 8/9 (89%)
vs. placebo 2/8 (25%); p = 0.0075). In patients who entered the
trial not in AF or AFL, there were a total of 45 incident episodes
of AFL during the trial, with fewer new onset AFL cases in the
bucindolol group [bucindolol 17/1193 (1.4%) vs. Placebo 28/1182
(2.4%); HR = 0.55 (95% CI 0.30, 1.01)]. This prevention of AFL was
similar to previous reports of AF prevention by bucindolol and,
therefore, AF and AFL were grouped into one endpoint (AFL/AF).
There was significantly less new onset AFL/AF with bucindolol
compared to placebo [bucindolol 88/1193 (7.4%) vs. placebo 137/1182
(11.6%); HR 0.58 (95% CI 0.45, 0.76)]. In the BEST DNA substudy,
prevention of AFL/AF was observed exclusively in the β1 Arg/Arg
subgroup [HR 0.29(0.14,0.60)] compared to the β1 Gly carrier group
[HR 0.91 (0.53, 1.56)] with a significant interaction between the
genotype and treatment (p = 0.019).
The authors concluded: “Bucindolol appears to prevent atrial
flutter to a similar degree and by a similar mechanism as atrial
fibrillation and, therefore, grouping atrial flutter with atrial
fibrillation appears to be a legitimate endpoint in HFREF AF
prevention trials.”
Atrial Flutter (AFL)
Atrial flutter is the second most common abnormal heart rhythm,
or tachyarrhythmia, after atrial fibrillation. The condition is a
type of supraventricular (above the ventricles) tachycardia (rapid
heartbeat). In AFL, the upper chambers, or atria, of the heart beat
too fast, which results in atrial muscle contractions that are
faster than and out of sync with the lower chambers, or ventricles.
AFL itself is not life threatening. If left untreated, the side
effects of AFL can be potentially life threatening. Without
treatment, AFL can also cause another type of arrhythmia called
atrial fibrillation, the most common type of abnormal heart rhythm.
Approximately 200,000 new cases of atrial flutter are estimated to
be diagnosed in the United States each year.
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 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, potential timeline for
GENETIC-AF trial activities, 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, Gencaro’s
potential efficacy in treating atrial flutter, future treatment
options for patients with atrial fibrillation or atrial flutter,
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, 2014, and subsequent
filings. The Company disclaims any intent or obligation to update
these forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20150909005641/en/
ARCA biopharma, Inc.Derek Cole,
720-940-2163derek.cole@arcabiopharma.com
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