Current Report Filing (8-k)
05 February 2015 - 8:36AM
Edgar (US Regulatory)
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): February 4, 2015 (February 4, 2015)
ARCA biopharma, Inc.
(Exact Name of Registrant as Specified in Charter)
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Delaware |
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000-22873 |
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36-3855489 |
(State or Other Jurisdiction
of Incorporation) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
11080 CirclePoint Road, Suite 140, Westminster, CO 80020
(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 February 4, 2015,
ARCA biopharma, Inc. (ARCA) announced that the U.S. Patent and Trademark Office issued a patent on methods and compositions of the S-isomer formulation of Gencaro (bucindolol hydrochloride). The press release is furnished as Exhibit 99.1
hereto, the contents of which are incorporated herein by reference.
Section 9 Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d)
Exhibits.
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Exhibit
Number |
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Description |
99.1 |
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Press Release titled ARCA biopharma Announces Patent Issuance for Methods and Compositions of S-Isomer Formulation of Gencaro dated February 4, 2015. |
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: February 4, 2015
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ARCA biopharma, Inc.
(Registrant) |
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By: |
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/s/ Christopher Ozeroff |
Name: |
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Christopher Ozeroff |
Title: |
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SVP and General Counsel |
INDEX TO EXHIBITS
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Exhibit
Number |
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Description |
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99.1 |
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Press Release titled ARCA biopharma Announces Patent Issuance for Methods and Compositions of S-Isomer Formulation of Gencaro dated February 4, 2015. |
Exhibit 99.1
ARCA BIOPHARMA ANNOUNCES PATENT ISSUANCE FOR METHODS AND
COMPOSITIONS OF S-ISOMER FORMULATION OF GENCARO
Patent
Includes Methods for Treating Multiple Cardiovascular Disease Indications
Westminster, CO, February 4, 2015 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 and compositions of the S-isomer
formulation of GencaroTM (bucindolol hydrochloride). The patent (USP# 8946284), entitled Methods and Compositions involving (S)-Bucindolol, provides intellectual property protection in
the United States for the use of S-isomer Gencaro (Gencaro substantially free of its R-stereoisomer) as a potential treatment for right ventricular heart failure, congestive heart failure, hypertension, angina, myocardial infarction, cardiac
arrhythmia, mitral valve prolapse, hypertrophic obstructive cardiomyopathy, or acute dissecting aortic aneurysm.
We are pleased with the
USPTOs issuance of this patent, which we believe broadens our intellectual property protection around Gencaro in multiple important cardiovascular disease indications which impact large patient populations globally, said Michael
R. Bristow, President and Chief Executive Officer of ARCA. This patent is a result of ARCAs continued focus on innovation in cardiovascular drug development. The S-isomer of Gencaro contains the high affinity beta-1 and beta-2
receptor-blocking action as well as nitric oxide generating activity. In GENETIC-AF, our on-going Phase 2B/3 clinical trial, we are evaluating racemic (contains both S and R isomers) Gencaro as a potential treatment for the prevention of atrial
fibrillation in a pharmacogenetically defined heart failure population at high risk of developing recurrent atrial fibrillation.
About ARCA biopharma
ARCA 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 evaluated as a potential treatment for atrial fibrillation in the Phase 2B/3
GENETIC-AF clinical trial, which is enrolling patients in the United States and Canada. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first approved
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, the potential for S-isomer Gencaro to possibly be a treatment for several different cardiovascular indications, the potential for genetic variations to predict individual
patient response to Gencaro, Gencaros potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention
treatment. 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; results of
earlier clinical trials may not be confirmed in future trials, 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, 2013, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.
Investor & Media Contact:
Derek Cole
720.940.2163
derek.cole@arcabiopharma.com
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