LOS ANGELES, Jan. 12, 2015 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that the first three patients have been treated in its DYNAMIC clinical trial. The trial is being conducted by Dr. Raj Makkar and his colleagues at Cedars-Sinai Heart Institute in Los Angeles. The Phase I DYNAMIC trial, also known as the "Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells" trial, will evaluate CDCs (CAP-1002) in patients with advanced heart failure. The Phase I trial is being funded in part through a grant of approximately $3 million from the National Institutes of Health (NIH).
The Phase I trial will enroll 14 patients with either ischemic or non-ischemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) ≤ 35% and New York Heart Association (NYHA) Class III or Ambulatory Class IV heart failure. Suitable patients will undergo sequential intracoronary infusion (triple vessel infusion) of CAP-1002 in up to three coronary territories. The primary safety endpoints will be assessed at the 1-month visit. Safety and exploratory efficacy endpoints including ejection fraction, ventricular volumes and a six-minute walk test will be evaluated at both the 6 and 12 month follow-up. It is hoped that following the successful 14 patient lead-in phase of DYNAMIC, the safety results will support continuation to a subsequent phase that includes a randomized, control cohort.
Capricor is concurrently conducting the 300 patient, Phase II ALLSTAR trial with CAP-1002 in patients thirty days to one year following large myocardial infarctions (heart attack). ALLSTAR is designed to determine safety and effectiveness at scar size reduction of CAP-1002 in patients at high risk following myocardial infarction. Phase II of the ALLSTAR trial is being funded with the support of the California Institute for Regenerative Medicine.
DYNAMIC Principal Investigator, Dr. Raj Makkar commented, "DYNAMIC represents the next significant step forward in the study of CDCs in patients with heart disease. ALLSTAR is studying patients treated within one year of a large heart attack but not yet severely symptomatic. DYNAMIC is studying a much more ill cohort who suffer from clinically relevant, advanced heart failure. We are hopeful that these studies will provide evidence for the role of CDCs across a broad spectrum of heart disease."
Dr. Linda Marban, Capricor CEO added, "We are extremely excited to begin this clinical trial with the support of the NIH as it further advances the CAP-1002 development strategy. With heart failure affecting over 5 million people in the United States alone and the annual costs for treatment estimated to be in the multiple billions annually, there is a clear need for novel and effective treatments. In conjunction with our Cenderitide program, Capricor is well positioned in the field of heart failure."
For more information, please visit: http://capricor.com/clinical-trials/dynamic/.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (CAPR), a publicly traded biotechnology company, is focused on the development of novel therapeutics to prevent and treat heart disease. The Company has two leading product candidates: CAP-1002 and Cenderitide. The Company was formed through the November 2013 merger between Capricor, Inc., a privately held company whose mission is to improve the treatment of heart disease by commercializing cardiac stem cell therapies for patients, and Nile Therapeutics, Inc., a clinical-stage biopharmaceutical company developing innovative products for the treatment of cardiovascular diseases. For additional information visit www.capricor.com.
About CAP-1002
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.
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; 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 Form 10-K for the year ended December 31, 2013, as filed with the Securities and Exchange Commission on March 31, 2014, in our Amendment No. 1 to Registration Statement on Form S-1, as filed with the Securities and Exchange Commission on May 23, 2014, and in our Form 10-Q for the quarter ended September 30, 2014, as filed with the Securities and Exchange Commission on November 14, 2014. 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.