Capricor completes enrollment of initial phase of DYNAMIC clinical trial for the treatment of advanced heart failure

Capricor Therapeutics, Inc. has 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.

Capricor enrolled 14 patients at a single centre in just over 3 months

“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 centre 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 about Carpricor, please visit www.capricor.com.