LabCorp/ARCA biopharma GENETIC-AF Poster Presented at the 18th Annual Scientific Meeting of the Heart Failure Society of Amer...
September 16 2014 - 8:00AM
Business Wire
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.
Investors & Media:ARCA biopharma, Inc.Derek Cole,
720-940-2163derek.cole@arcabiopharma.com
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