ARCA biopharma Announces Health Canada Acceptance of Genetic-AF Clinical Trial Application
August 18 2014 - 8:30AM
Business Wire
Canadian Site Activation for Phase 2B/3
Clinical Trial to Begin in 2014
Gencaro Potentially the First
Genetically-Targeted Cardiovascular Treatment
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically targeted therapies for cardiovascular
diseases, today announced that the Company’s Clinical Trial
Application (CTA) for the GENETIC-AF clinical trial evaluating
GencaroTM as a potential treatment for atrial fibrillation (AF) has
been accepted by Health Canada. ARCA anticipates that clinical
trial sites in Canada will be active in the fourth quarter of
2014.
Dr. Michael R. Bristow, President and
CEO, ARCA biopharma, Inc. (Photo: Business Wire)
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 currently
enrolling patients in the United States. 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.
Dr. Michael R. Bristow, Founder and CEO of ARCA, commented, “At
ARCA, we believe a personalized medicine approach to drug
development, tailoring medical treatment to the individual genetic
characteristics of each patient, can enable more effective
therapies, improve patient outcomes and reduce healthcare costs. If
the GENETIC-AF trial successfully confirms the atrial fibrillation
data analysis from a prior Phase 3 clinical trial, Gencaro has the
potential to be the first genetically targeted treatment for the
prevention of this important cardiovascular disorder and provide a
much needed treatment option for patients in an area of high unmet
medical need.”
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.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20140818005083/en/
ARCA biopharmaInvestor & Media Contact:Derek
Cole, 720-940-2163derek.cole@arcabiopharma.com
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Aug 2024 to Sep 2024
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Sep 2023 to Sep 2024