LOS ANGELES, June 16, 2016 /PRNewswire/ -- Capricor Therapeutics, Inc. (CAPR), a biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics, today announced positive preliminary 12-month data from its DYNAMIC (Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells) clinical trial, which evaluated CAP-1002 in patients with advanced heart failure. CAP-1002 is Capricor's investigational allogeneic cardiosphere-derived cell (CDC) therapy.
In DYNAMIC, 14 patients with New York Heart Association (NYHA) Class III heart failure were treated with multi-vessel intracoronary infusion of CAP-1002 in four escalating dose cohorts. All patients received a one-time, triple-vessel infusion of CAP-1002 at doses ranging from 37.5 million to 75 million cells. Patients were followed for 12 months, and all echocardiographic studies were read by a core lab.
As observed at six months, directional improvements from baseline in key efficacy measures, including assessments of functional status, cardiac function and dimensions, and quality-of-life, were previously reported. Among these, statistically-significant...
About the DYNAMIC clinical trial
The Phase I DYNAMIC (Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells) clinical trial evaluated CAP-1002 (allogeneic cardiosphere-derived cells) in patients with advanced heart failure. The trial was open to patients with New York Heart Association (NYHA) Class III or ambulatory Class IV heart failure characterized by ischemic or non-ischemic dilated cardiomyopathy in which left ventricular ejection fraction was 35% or less. Suitable patients underwent sequential intracoronary infusion of CAP-1002 in up to three coronary territories. This triple vessel infusion was designed to broadly deliver cells to the myocardium, since patients with advanced heart failure have diffuse fibrosis throughout the heart.