UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 30, 2011 (December 30, 2011)
ARCA biopharma, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware | 000-22873 | 36-3855489 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
8001 Arista Place, Suite 430, Broomfield, CO 80021
(Address of Principal Executive Offices) (Zip Code)
(720) 940-2200
(Registrants telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Section 8 Other Events
Item 8.01 Other Events.
On December 30, 2011, ARCA issued a press release announcing that the U.S. Patent and Trademark Office has issued a patent on methods for treating patients with bucindolol based on genetic targeting. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number |
Description | |
99.1 | Press Release titled ARCA biopharma Announces Additional Patent Issued for Methods for Treatment with Bucindolol Based on Genetic Targeting, dated December 30, 2011. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: December 30, 2011
ARCA biopharma, Inc. (Registrant) | ||
By: | /s/ Michael R. Bristow | |
Name: Michael R. Bristow | ||
Title: President and Chief Executive Officer |
INDEX TO EXHIBITS
Exhibit Number |
Description | |
99.1 | Press Release titled ARCA biopharma Announces Additional Patent Issued for Methods for Treatment with Bucindolol Based on Genetic Targeting, dated December 30, 2011. |
Exhibit 99.1
Contact:
Derek Cole
Vice President, Investor Relations & Corporate Communications
720.940.2163
derek.cole@arcabiopharma.com
ARCA BIOPHARMA ANNOUNCES ADDITIONAL PATENT ISSUED FOR METHODS
FOR TREATMENT WITH BUCINDOLOL BASED ON GENETIC TARGETING
------------------------------------------------------------------------
Prospective Knowledge of Alpha-2C Genotype May Allow for Prediction of
Degree of Norepinephrine Lowering by Bucindolol in Individual Patients
Broomfield, CO, December 30, 2011 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods for treating patients with bucindolol based on genetic targeting and focused on a specific genotype homozygous wildtype for Deletion 322-325 in the alpha-2C adrenergic receptor. The patent (USP# 8,080,578) entitled Methods for Treatment with Bucindolol Based on Genetic Targeting, provides protection in the United States for this novel approach to treating patients with bucindolol.
We are obviously pleased with the USPTOs issuance of this patent, which we believe extends our pharmacogenetic intellectual property protection around bucindolol said Michael R. Bristow, President and Chief Executive Officer of ARCA. Chronic cardiovascular diseases continue to be a major health care problem, and among the challenges to improving care is the uncertainty of patient responses to drug treatment. We believe new therapies that include a simple test to identify a substantial subpopulation of patients more likely to benefit have the potential to alleviate some of the problems encountered with the current standard of pharmacotherapy, where all members of a disease cohort, including those who will not respond, are treated. A unique pharmacologic property of bucindolol is norepinephrine lowering, and bucindolols heart failure clinical responses demonstrated in a large Phase 3 clinical trial (BEST) were modulated by this important effect. The degree of norepinephrine lowering by bucindolol is under genetic control by alpha-2C 322-325 Insertion/Deletion adrenergic receptor polymorphisms (Circulation Heart Failure: 3:21-28 2010). Accordingly, we believe prospective knowledge of the alpha-2C 322-325 genotype allows for prediction of the degree of norepinephrine lowering by bucindolol in an individual patient.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Companys 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 is collaborating with Laboratory Corporation of America to develop the companion genetic test for Gencaro. 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 issuance of, and protection provided by, U.S. Patent 8,080,578 entitled Methods for Treatment with Bucindolol Based on Genetic Targeting and statements regarding the potential for knowledge of the alpha-2C genotype to predict individual patient response to Gencaro; the ability of genetic variations to predict individual patient response to Gencaro; the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment; and the Companys ability to fund future operations. Such statements are based on managements 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 Companys financial resources and whether they will be sufficient to meet the Companys business objectives and operational requirements; the protection and market exclusivity provided by the Companys 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 ARCAs filings with the SEC, including without limitation the Companys annual report on Form 10-K for the year ended December 31, 2010 and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.
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