Date: 2015-04-08
Type of information: Completion of patient enrollment
phase: 1
Announcement: completion of patient enrollment
Company: Capricor Therapeutics (USA - CA)
Product: CAP-1002
Action
mechanism: cell therapy. Capricor’s lead product candidate, CAP-1002, is an allogeneic, “off the shelf” cardiosphere-derived cell (CDC) product. The proprietary process employed to generate Capricor’s CDCs is a unique methodology created in the laboratory of company Co-Founder and Scientific Advisory Board Chairman, Dr. Eduardo Marbán, Director of the Heart Institute at Cedars-Sinai Medical Center.
Disease: advanced heart failure
Therapeutic area: Cardiovascular diseases
Country: USA
Trial
details: The Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells (DYNAMIC) Phase I trial will evaluate CAP-1002 in patients with advanced heart failure. These patients have progressed to a more advanced stage of the disease than patients being evaluated in the ALLSTAR trial. Patients will receive CAP-1002 in up to three coronary arteries, enabling delivery of the drug product to more of the diseased heart tissue. Additionally, the cells will be delivered using a non-stop flow technique. Other cell therapies use a balloon to stop blood flow during the infusion procedure, which could potentially damage blood vessels and cause chest discomfort in patients. The non-occlusive intracoronary infusion delivery method in DYNAMIC is likely to provide more comfort for patients – without compromising efficacy – as blood flow will not be stopped during infusion (NCT02293603).
Latest
news: * On April 8, 2015, Capricor Therapeutics, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, 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.
