ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular diseases,
today announced the activation of the first GENETIC-AF clinical trial
site in Canada. The site activation follows on the August 2014
acceptance by Health Canada of the Company’s Clinical Trial Application
(CTA) for the GENETIC-AF clinical trial evaluating GencaroTM
as a potential treatment for atrial fibrillation (AF). This site brings
the total current number of active trial sites to thirty-three. ARCA
plans to activate a total of approximately 60 clinical trial sites in
the United States and Canada for the Phase 2B portion of the trial.
ARCA is evaluating Gencaro, a pharmacologically unique beta-blocker and
mild vasodilator, as a potential treatment for AF in the Phase 2B/3
GENETIC-AF clinical trial, which is now 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
potential to be the first genetically-targeted therapy for the
prevention of atrial fibrillation.
Stuart Connolly, MD, Director of the Division of Cardiology at McMaster
University in Hamilton, Ontario, Canada, and Co-Chairman of the
GENETIC-AF Steering Committee, commented, “This trial is an innovative
pharmacogenetic approach to evaluating the potential efficacy of
bucindolol as a treatment for atrial fibrillation. Atrial fibrillation
is a growing problem where current medical therapy does not provide
adequate treatment, particularly in heart failure populations.”
Jeff Healey, MD and Country Principal Investigator, commented further,
“Canadian health care and its clinical trial culture is ideally suited
for a trial such as GENETIC-AF, which investigates a potential advance
in the unmet need areas of atrial fibrillation prevention and/or rate
control in a heart failure population. I hope the Canadian GENETIC-AF
trial sites will contribute a substantial number of patients to this
program to help advance a potential new treatment for patients at high
risk for developing, or living with, atrial fibrillation.”
About Atrial Fibrillation (AF)
Atrial fibrillation, the most common sustained cardiac arrhythmia, is
considered an epidemic cardiovascular disease and a major public health
burden. The estimated number of individuals with AF globally in 2010 was
33.5 million. According to the 2014 American Heart Association report on
Heart Disease and Stroke Statistics, the estimated number of individuals
with AF in the U.S. in 2010 ranged from 2.7 million to 6.1 million
people. Hospitalization rates for AF increased by 23% among US adults
from 2000 to 2010 and hospitalizations account for the majority of the
economic cost burden associated with AF.
AF is a disorder in which the normally regular and coordinated
contraction pattern of the heart’s two small upper chambers (the atria)
becomes irregular and uncoordinated. The irregular contraction pattern
associated with AF causes blood to pool in the atria, predisposing the
formation of clots potentially resulting in stroke. AF increases the
risk of mortality and morbidity due to stroke, congestive heart failure
and impaired quality of life. The approved therapies for the treatment
or prevention AF have certain disadvantages in patients with heart
failure and/or reduced left ventricular ejection fraction (HFREF)
patients. These include toxic or cardiovascular adverse effects, and
most of the approved drugs for AF are contra indicated or have warnings
in their prescribing information for such patients. The Company believes
there is an unmet medical need for new AF treatments that have fewer
side effects than currently available therapies and are more effective,
particularly in HFREF patients.
GENETIC-AF Clinical Trial
GENETIC-AF is a Phase 2B/3, multi-center, randomized, double-blind
clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL
for prevention of symptomatic AF/atrial flutter in HFREF patients. 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
initiated the trial as a Phase 2B trial in approximately 200 patients.
The GENETIC-AF Data Safety Monitoring Board (DSMB) will analyze certain
data from the Phase 2B portion of the trial and recommend, based on a
comparison to the pre-trial statistical assumptions, whether the trial
should proceed to Phase 3 and seek to enroll an additional 420 patients.
The AF indication for Gencaro was chosen based on clinical data from the
previously conducted Phase 3 heart failure trial of 2,708 patients (the
BEST trial). The Company believes data from the BEST trial indicate that
Gencaro may have a genetically regulated effect in reducing or
preventing AF, whereas the Company believes the therapeutic benefit of
Toprol-XL does not appear to be enhanced in patients with this genotype.
A retrospective analysis of data from the BEST trial shows that the
entire cohort of patients in the BEST trial treated with Gencaro had a
41% reduction in the risk of new onset AF (time-to-event) compared to
placebo (p = 0.0004). In the BEST DNA substudy, patients with the beta-1
389 arginine homozygous genotype experienced a 74% (p = 0.0003)
reduction in risk of AF when receiving Gencaro, based on the same
analysis.
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, 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, 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.
Copyright Business Wire 2014