Arca biopharma Announces Activation of First Canadian Genetic-AF Clinical Trial Site
December 11 2014 - 8:30AM
Business Wire
Clinical Trial is Evaluating Gencaro as a
Potential Treatment for Atrial Fibrillation
Approximately 60 Trial Sites Planned in the
United States and Canada
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.
ARCA biopharma, Inc.Derek Cole,
720-940-2163derek.cole@arcabiopharma.com
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