Pharmaceutical Business review

Capricor completes patient enrollment in initial phase of DYNAMIC trial of heart failure drug candidate

CAP-1002 is being developed to treat advanced heart failure, including patients who were Class III or ambulatory Class IV with ejection fractions of 35% or below.

A total of 14 patients were enrolled in the trial and they were administered CAP-1002 down all three coronary arteries (triple vessel infusion using standard intracoronary catheter).

The triple vessel infusion is designed to deliver cells to wide areas of myocardium, as patients with advanced heart failure have significant fibrosis in all areas of the left ventricle.

Funded through a grant from the National Institutes of Health (NIH), the trial is designed to evaluate the safety, as well as a variety of exploratory six and 12 month efficacy endpoints including ejection fraction, ventricular volumes and a six-minute walk test.

Capricor chief executive officer Linda Marban said: "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.

"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."

The company said that results from this trial are expected to be reported later this year.