LOS ANGELES, June 8, 2015 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for the clinical development of CAP-1002 for the treatment of patients with Duchenne Muscular Dystrophy (DMD) related cardiomyopathy. CAP-1002 is Capricor's allogeneic, cardiosphere-derived cell (CDC) therapy already in clinical development for the treatment of heart disease.
Linda Marbán, Ph.D., Chief Executive Officer of Capricor, said "Cardiomyopathy is the leading cause of death in DMD patients, due to the improvement in treatments for respiratory failure. The HOPE trial will evaluate our CDC product, CAP-1002, for the first time in patients suffering from DMD with significant cardiac dysfunction. The potential of CAP-1002 to provide a treatment option for the cardiomyopathy associated with DMD is exciting as the therapy is designed to improve clinical outcomes in patients. We believe CDCs could potentially be used in conjunction with any of the therapeutics currently in use or under investigation for the skeletal muscle pathology. Further, the use of our CDC platform for the possible treatment of cardiomyopathy-related DMD demonstrates the potential versatility of our CDCs."
The HOPE-DUCHENNE trial is designed to enroll up to 24 patients in a randomized, multi-center study evaluating the safety and preliminary efficiency of CAP-1002. Patients will receive CAP-1002 in all three coronary arteries which will allow for it to be delivered to wide areas of the myocardium similar to that which was used earlier this year in the DYNAMIC trial. Previously, Capricor was granted orphan drug designation by the FDA for CAP-1002 used for the treatment of cardiomyopathy associated with DMD.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (Nasdaq:CAPR) is a clinical-stage biotechnology company with expertise in the field of cardiovascular disease aiming to develop novel therapies for diseases with significant unmet medical needs. Our lead programs target post myocardial infarction (heart attack), heart failure and Duchenne Muscular Dystrophy. The Company has two leading product candidates under investigation: Cenderitide, a natriuretic peptide receptor agonist, and CAP-1002, a cardiac cell therapy. Cenderitide is in development for the outpatient treatment of heart failure as well as potential other indications. CAP-1002 is in development for the treatment of post myocardial infarction (heart attack), advanced heart failure and Duchenne muscular dystrophy associated cardiomyopathy. In addition, the Company is conducting research and development on its exosomes platform technology for cardiac diseases and other potential indications. For additional information visit www.capricor.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the conduct, size, timing and results of discovery efforts and clinical trials; scope, duration, validity and enforceability of intellectual property rights; plans regarding regulatory filings, future research and clinical trials; plans regarding current and future collaborative activities and the ownership of commercial rights; future royalty streams, and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact our business are set forth in our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on March 16, 2015, in our Registration Statement on Form S-1, as filed with the Securities and Exchange Commission on March 6, 2015 and in our Quarterly Report on Form 10-Q for the period ending March 31, 2015, as filed with the Securities and Exchange Commission on May 13, 2015. All forward-looking statements in this press release are based on information available to us as of the date hereof, and we assume no obligation to update these forward-looking statements.