LOS ANGELES, Nov. 6, 2015 /PRNewswire/ -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics, today announced that results will be presented from its ongoing Phase I DYNAMIC (Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells) clinical trial evaluating CAP-1002 in patients with advanced heart failure. The data will be presented in a poster presentation at the 2015 American Heart Association (AHA) Scientific Sessions taking place November 7-11, 2015 in Orlando, FL. CAP-1002 is Capricor's lead investigational allogeneic, cardiosphere-derived cell (CDC) therapy.
Title: Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells (DYNAMIC): Six Month Safety and Exploratory Efficacy Results
Date & Time: Monday, November 9, 2015, 5:30 - 6:45PM ET
Location: Poster Hall, A2, BS
Poster #: M 1041
Session ID: APS.06.02. Stem/Progenitor Cells II
The Phase I DYNAMIC trial is evaluating CDCs (CAP-1002) in patients with advanced heart failure. The trial enrolled 14 patients with either ischemic or non-ischemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 35% or below and New York Heart Association (NYHA) Class III or Ambulatory Class IV heart failure. Suitable patients underwent sequential intracoronary infusion of CAP-1002 in up to three coronary territories. The primary safety endpoints were assessed at the 1-month visit. Other safety and exploratory efficacy endpoints including ejection fraction, ventricular volumes and a six-minute walk test were evaluated at 6 months and will be evaluated at a 12-month follow-up. The Phase I trial is being funded in part through a grant of approximately $3 million from the National Institutes of Health (NIH).
CAP-1002, Capricor's lead product candidate, is a proprietary allogeneic adult stem cell therapy for the treatment of heart disease. The product is derived from donor heart tissue. The cells are expanded in the laboratory using a specialized process and then introduced directly into a patient's heart via infusion into a coronary artery using standard cardiac catheterization techniques.
CAP-1002 is currently not an approved product and is strictly for investigational purposes.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics. Our lead programs target post myocardial infarction (heart attack), heart failure and Duchenne Muscular Dystrophy. The Company has two lead product candidates under investigation: CAP-1002, a cardiac cell therapy and Cenderitide, a natriuretic peptide receptor agonist. CAP-1002 is in development for the treatment of post myocardial infarction (heart attack), advanced heart failure and Duchenne muscular dystrophy associated cardiomyopathy. Cenderitide is in development for the outpatient treatment of heart failure as well as potential other indications. 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-3, as filed with the Securities and Exchange Commission on September 25, 2015, and in our Quarterly Report on Form 10-Q for the period ending June 30, 2015, as filed with the Securities and Exchange Commission on August 14, 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.
For more information, please contact:
Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance
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SOURCE Capricor Therapeutics, Inc.