Capricor Therapeutics, Inc. 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.