ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular diseases,
today announced that Laboratory Corporation of America (LabCorp®) (NYSE:
LH) has informed ARCA that the U.S. Food and Drug Administration (FDA)
has accepted LabCorp’s Investigational Device Exemption (IDE)
application for the planned companion diagnostic test for GencaroTM
(bucindolol hydrochloride), a pharmacologically unique beta-blocker and
mild vasodilator being developed for atrial fibrillation (AF). The IDE
allows the companion diagnostic test to be used in the planned
GENETIC-AF clinical trial. ARCA’s Gencaro Investigational New Drug (IND)
application for AF has been accepted by the U.S. Food and Drug
Administration (FDA) and is active.
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 AF prevention treatment. LabCorp and ARCA
have developed the companion diagnostic test for Gencaro to identify
patient genotypes based on these genetic variations of the beta-1
cardiac receptor. LabCorp will provide the patient genetic testing for
ARCA’s GENETIC-AF clinical trial of Gencaro, which is expected to begin
patient enrollment in the first quarter of 2014.
GENETIC-AF Clinical Trial
GENETIC-AF is planned as a Phase 2B/3, multi-center, randomized,
double-blind clinical trial comparing Gencaro to Toprol-XL for
prevention of AF in patients with heart failure and reduced left
ventricular ejection fraction (HFREF). 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 plans to initiate it as a
Phase 2B study in approximately 200 patients and then, depending on the
results of an interim analysis by the trial Data Safety Monitoring Board
(DSMB), expand the trial to a Phase 3 study by enrolling an estimated
additional 420 patients. Medtronic, Inc. is collaborating with ARCA on
the GENETIC-AF trial. The Company anticipates that patient enrollment in
GENETIC-AF will begin in the first quarter of 2014.
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, the role of AF burden in diagnosis and treatment of 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, 2012, and subsequent
filings. The Company disclaims any intent or obligation to update these
forward-looking statements.
Copyright Business Wire 2014