Therapeutic Pipeline

Capricor’s therapeutic programs are built around our proprietary and novel CDC technology. The autologous Cardiosphere-derived stem cell or CDC Program has achieved proof of concept in the laboratory and in a variety of small and large animal models.  All but one of the programs are expected to initiate FDA phase I/II clinical safety trials in the coming 12 to 18 months.

CPI-002

CPI-002 is a direct injection formulation of the CDCs into the heart muscle itself for the treatment of myocardial infarction.  Large animal dosing and safety studies are currently underway at partner institution Cedars-Sinai Medical Center.  A Food & Drug Administration (FDA) Investigation New Drug (IND) application for a phase I/II human clinical trial is planned for 2009.

CPI-003

CPI-003 is Capricor’s front line CDC therapeutic program for the treatment of myocardial infarction, offering a catheter infusible formulation of CDCs for patients with a recent MI or heart attack. Large animal studies were completed in September 2007. An Investigational New Drug (IND) application is in preparation and will be submitted to the Food & Drug Administration (FDA) in collaboration with groups from Cedars-Sinai Medical Center and Johns Hopkins Medical School.

CPI-004

CPI-004 builds upon the successful preparation of CDCs for treatment of myocardial infarction. One of the key issues for any cardiac stem cell therapy is the method of delivery of the cells into the heart, in a manner allowing the cells to remain viable, functional, and able to repair the heart muscle. While direct infusion and injection into the cardiac veins and heart muscle have had success, various matrices have been shown to enhance survival and function of stem cells. Capricor is engaged in studies to develop and optimize CDC and matrix combinations to dramatically increase the therapeutic effectiveness of cardiac stem cell treatment in collaboration with matrix and tissue engineering partners.

CPI-005

CPI-005 is a CDC therapeutic program that expands the CPI-003 CDC catheter formulation to a chronic heart failure patient population.  These patients typically show rapidly declining cardiac function with very few available interventions.  An FDA IND and phase I/II clinical safety study is planned for 2009..