ARCA biopharma Announces Steering Committee for GENETIC-AF Trial

  ARCA biopharma Announces Steering Committee for GENETIC-AF Trial

 Cardiology and Electrophysiology Experts to Provide Scientific Oversight and
Guidance for Phase 2B/3 Clinical Trial of Gencaro as a Potential Treatment for
                             Atrial Fibrillation

Business Wire

BROOMFIELD, Colo. -- July 24, 2013

ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing
genetically-targeted therapies for cardiovascular diseases, today announced
the Steering Committee for GENETIC-AF, the Company’s Phase 2B/3 trial
evaluating Gencaro^TM (bucindolol hydrochloride) as a potential treatment for
atrial fibrillation. The Steering Committee is comprised of experts in the
field of cardiology and electrophysiology, particularly in clinical
development.

Stuart Connolly, MD, Director of the Division of Cardiology at McMaster
University in Hamilton, Ontario, has been appointed Chairman of the Steering
Committee. William T. Abraham, MD, Director of the Division of Cardiovascular
Medicine at The Ohio State University Wexner Medical Center, has been
appointed co-Chair of the Steering Committee.

“The Steering Committee of GENETIC-AF provides a balance of atrial
fibrillation and heart failure clinical trials expertise, with each member
being an expert in one or the other or both,” said Dr. Michael R. Bristow,
President and Chief Executive Officer of ARCA. “We are delighted to have Dr.
Connolly chair the Steering Committee. He brings a wealth of experience over a
distinguished career in the field of electrophysiology, particularly in
clinical trials in atrial fibrillation, which makes him a natural fit to help
guide the development of Gencaro. Dr. Abraham is also an expert in heart
failure clinical investigation and brings a background of leadership in both
drug and device trials in chronic heart failure populations. Thus, GENETIC-AF
will have the benefit of trial leadership that is at the forefront of both
atrial fibrillation and heart failure outcome trials."

“I am honored to participate in the GENETIC-AF trial, an innovative approach
to evaluating the potential efficacy of Gencaro as a treatment for atrial
fibrillation,” said Dr. Connolly. "Atrial fibrillation is a growing problem
where current medical therapy does not provide adequate treatment,
particularly in heart failure populations. I look forward to working with the
teams at ARCA and Medtronic to advance a potential new treatment for patients
at high risk for developing, or living with, atrial fibrillation.”

Dr. Abraham said, "I am pleased to be closely involved with the GENETIC-AF
trial, which explores new territory on two important fronts: prospective
identification of a genetic subpopulation potentially more responsive to a
cardiovascular drug, and demonstration that a drug, in this case Gencaro, may
be safe and effective in preventing atrial fibrillation in the unmet need
population of heart failure with reduced left ventricular ejection fraction."

Additional Steering Committee members are:

  *Inder Anand, MD, of the University of Minnesota and Director of the Heart
    Failure Program at the Minneapolis VA Medical Center;
  *David E. Haines, MD, Director of the Heart Rhythm Center of William
    Beaumont Hospital;
  *Jonathan P. Piccini, MD, Director, Cardiac Electrophysiology Clinical
    Trials Program, Duke University Medical Center;
  *William H. Sauer MD, Director of the Electrophysiology Program at the
    University of Colorado Denver; and,
  *Dirk J. van Veldhuisen, MD, Chairman of Cardiology at the University
    Medical Center Groningen, the Netherlands.

The Steering Committee will provide scientific oversight for the GENETIC-AF
trial as well as communicate its recommendations regarding trial conduct with
the trial’s Data Safety Monitoring Board.

GENETIC-AF Clinical Trial

GENETIC-AF is planned as a Phase 2B/3, multi-center, randomized, double-blind
clinical trial comparing Gencaro to metoprolol CR/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. 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, Gencaro^TM
(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 Phase 2B portion 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.

Contact:

ARCA biopharma
Derek Cole
Investor Relations Advisory Solutions
720-940-2163
derek.cole@arcabiopharma.com
 
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