ARCA Announces Special Protocol Assessment Agreement With FDA For Bucindolol Development In Genotype-Defined Heart Failure Population
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for heart failure and other cardiovascular disease. The Company's lead product candidate, bucindolol hydrochloride, is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for heart failure. ARCA has identified common genetic variations that it believes predict individual patient response to bucindolol, giving it the potential to be the first genetically-targeted heart failure treatment. ARCA is collaborating with Laboratory Corporation of America to develop the companion genetic test for bucindolol. 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 the significance of the SPA agreement, which is not a guarantee of approval; the impact of the SPA on the likelihood of receiving marketing approval for bucindolol; the protection provided by the patent for methods of treating heart failure patients with bucindolol based on genetic testing; the timing and outcome of the Company’s bucindolol clinical trial; the significance of Fast Track designation; regulatory review and potential approval of the Company’s New Drug Application for bucindolol; the prospects for ARCA’s providing sufficient information in a timely manner as requested in the FDA’s Complete Response Letter; and, the Company’s ability to fund future operations. 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; the Company’s ability to complete a strategic transaction to support the continued development bucindolol, and/or obtain additional financing; the Company's ability to identify, develop and achieve commercial success for products and technologies; 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, 2009, the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2010 and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.
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