LOS ANGELES, April 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 it has completed enrollment of the initial phase of its DYNAMIC clinical trial for the treatment of advanced heart failure. DYNAMIC is a trial of CAP-1002, Capricor's allogeneic, cardiosphere-derived cell (CDC) therapy in clinical development for the treatment of advanced heart failure, including patients who were Class III or ambulatory Class IV with ejection fractions of 35% or below.
Fourteen patients were enrolled and were administered CAP-1002 down all three coronary arteries (triple vessel infusion using standard intracoronary catheter). DYNAMIC marks the first time that CAP-1002 has been used clinically in patients with severe, global left ventricular dysfunction. The triple vessel infusion is designed to deliver cells to wide areas of myocardium since patients with advanced heart failure have significant fibrosis in all areas of the left ventricle. Safety, as well as a variety of exploratory 6 and 12 month efficacy endpoints including ejection fraction, ventricular volumes and a six-minute walk test, will be evaluated. The study was funded through a grant from the National Institutes of Health. Data is expected to be available later this year.
"DYNAMIC is a major step forward for Capricor in that it is our first clinical trial directed at highly symptomatic patients with severe cardiac dysfunction. Our ongoing Phase II ALLSTAR trial delivers CAP-1002 into a single coronary vessel within the infarct zone in patients following a heart attack. We are hopeful that data from DYNAMIC will expand our potential indications to patients suffering from advanced stages of heart failure in addition to the post heart attack population." said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. She added "we enrolled 14 patients at a single center in just over 3 months, highlighting the unmet need and large market opportunity for new treatments in patients with Class III and ambulatory Class IV heart failure."
For more information, please visit: http://capricor.com/clinical-trials/dynamic/
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 tremendous 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 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, and in our Registration Statement on Form S-1, as filed with the Securities and Exchange Commission on March 6, 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.
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