ARCA biopharma and Medtronic Extend Gencaro Clinical Trial Collaboration Agreement
April 23 2018 - 8:30AM
ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company
applying a precision medicine approach to developing
genetically-targeted therapies for cardiovascular diseases, today
announced that Medtronic, Inc. (NYSE:MDT) has extended the U.S.,
Canadian and European Clinical Trial Collaboration Agreement with
ARCA for an additional year to April 2019.
Under the collaboration, Medtronic has supported
clinical trial use of its continuous monitoring devices, managed
atrial fibrillation burden data collection and managed analysis of
patients’ cardiac rhythms, via a Medtronic device, either a
previously implanted cardiac resynchronization or defibrillation
device, or a previously or newly inserted Reveal® loop
recorder.
Dr. Michael Bristow, MD, PhD, President and
Chief Executive Officer of ARCA, commented, “Medtronic has been a
terrific partner in exploring and understanding atrial fibrillation
in a clinical trial setting. We are excited to extend our
collaboration as we continue analysis of the trial data from
GENETIC-AF and consider potential future development plans for
Gencaro.”
About ARCA biopharma
ARCA biopharma is dedicated to developing
genetically-targeted therapies for cardiovascular diseases through
a precision medicine approach to drug development. ARCA’s lead
product candidate, GencaroTM (bucindolol hydrochloride), is an
investigational, pharmacologically unique beta-blocker and mild
vasodilator being developed for the potential treatment of patients
with atrial fibrillation (AF) and chronic heart failure with
reduced left ventricular ejection fraction (HFrEF) which recently
completed a Phase 2B clinical trial. 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. ARCA has a
collaboration with Medtronic, Inc. for support of the GENETIC-AF
trial. The Gencaro development program has been granted Fast Track
designation by FDA. ARCA also plans to develop AB171, a
thiol-substituted isosorbide mononitrate, as a potential
genetically-targeted treatment for peripheral arterial disease
(PAD) and for heart failure (HF). For more information, please
visit www.arcabio.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 the ability of ARCA’s
financial resources to support its operations through the end of
2018, potential future development plans for Gencaro, the expected
features and characteristics of Gencaro or AB171, including the
potential for genetic variations to predict individual patient
response to Gencaro, Gencaro’s potential to treat AF, AB171’s
potential to treat HF, future treatment options for patients with
AF, and the potential for Gencaro to be the first
genetically-targeted AF 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: ARCA’s financial resources
and whether they will be sufficient to meet its business objectives
and operational requirements; ARCA may not be able to raise
sufficient capital on acceptable terms, or at all, to continue
development of Gencaro or to otherwise continue operations in the
future; results of earlier clinical trials may not be confirmed in
future trials; the protection and market exclusivity provided by
ARCA’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 Securities and Exchange Commission, including without
limitation ARCA’s annual report on Form 10-K for the year ended
December 31, 2017, and subsequent filings. ARCA disclaims any
intent or obligation to update these forward-looking
statements.
Investor & Media
Contact:Derek Cole720.940.2163derek.cole@arcabio.com
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