ARCA biopharma, Inc. (ARCA) (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular diseases,
today announced that a joint Laboratory Corporation of America®
Holdings (LabCorp®) (NYSE:LH) and ARCA personalized medicine
abstract was presented yesterday evening at the 18th Annual
Scientific Meeting of the Heart Failure Society of America, being held
September 14-17, 2014 in Las Vegas, Nevada. The poster describes the
genetic test that is being used to select patients for GENETIC-AF, a
Phase 2B/3 adaptive design clinical trial. The GENETIC-AF trial will
evaluate Gencaro™ (bucindolol hydrochloride) as a potential treatment
for the prevention of atrial fibrillation (AF) in patients with heart
failure and left ventricular dysfunction who also have a specific
genotype of the beta-1 adrenergic receptor (389 arginine homozygous),
which ARCA believes is present in approximately 50% of the U.S.
population. LabCorp is performing the genetic testing for the GENETIC-AF
trial.
Melissa Barhoover, Ph.D., IVD Regulatory Manager at LabCorp Clinical
Trials, and Christopher Dufton, Ph.D., Vice President, Clinical
Development at ARCA, presented “Personalized Medicine: Prospective
Patient Selection Utilizing an ADRB1 Genotype Assay in the GENETIC-AF
Clinical Trial” during the poster session Monday, September 15, 2014,
5:15 – 6:15 pm PT.
Poster/abstract summary: It has been previously reported in a
pharmacogenomic substudy of the BEST trial, the 1040 patient BEST DNA
substudy, that patients with a beta-1 adrenergic receptor (ADRB1)
Arg389Arg genotype exhibited enhanced clinical efficacy in response to
treatment with the β-blocker/sympatholytic agent Gencaro™ compared to
patients with ADRB1 389Gly genotypes. The results of the substudy
demonstrated a significant (p=0.0003) and substantial 74% decrease in
new-onset atrial fibrillation (AF) by Gencaro that was exclusively
identified in patients with an ADRB1 Arg389Arg genotype. A prospective
pharmacogenetic patient selection clinical trial (GENETIC-AF) is
underway to confirm these initial results. LabCorp has developed and
validated a clinical trials assay for ADRB1 genotype to support the
GENETIC-AF clinical trial.
The poster/abstract concludes: “The LabCorp ADRB1 Genotype Assay is
analytically validated for use in a clinical trial where it is being
used for patient selection. The FDA has approved the investigational
device exemption (IDE) for the LabCorp ADRB1 Genotype Assay and the
GENETIC-AF trial is currently on-going.”
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies
for cardiovascular diseases. The Company's lead product candidate,
Gencaro™ (bucindolol hydrochloride), is an investigational,
pharmacologically unique beta-blocker and mild vasodilator being
evaluated for atrial fibrillation in the Phase 2B/3 clinical trial
GENETIC-AF, which began enrolling patients in the second quarter of
2014. 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 and the referenced poster/abstract 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, 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