News | December 05, 2014

FDA Approves Biocardia’s CardiAMP Therapy for Phase III Clinical Trial

Trial will test efficacy of bone marrow-derived treatment for heart failure patients

December 5, 2014 — BioCardia Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s application to begin a Phase III clinical trial of its bone marrow-derived CardiAMP Therapy for heart failure. The clinical trial is a randomized, controlled, multi-center study of 250 patients evaluating CardiAMP Therapy at up to 40 clinical sites.

The CardiAMP Therapy for heart failure integrates a proprietary biomarker panel to identify candidates likely to respond to therapy, a cell processing system consisting of a proprietary high-dosage formulation of autologous bone marrow-derived cells, and a unique transendocardial delivery system that ensures efficient and consistent targeted delivery. This therapy will be reviewed under the PMA regulations by the FDA’s Center for Biologics Evaluation and Research (CBER) division.

The CardiAMP trial efficacy endpoints include improvements in functional capacity as measured by the Six Minute Walk Test, quality of life as measured by the Minnesota Living with Heart Failure Questionnaire, and survival.  Safety endpoints include non-inferiority with respect to survival and freedom from major adverse cardiac events.

Co-principal investigators for the trial are Carl Pepine, M.D., and Amish Raval, M.D., who were involved in the trial design. Pepine is professor of medicine, division of cardiovascular medicine, at the University of Florida (UF) and principal investigator for the UF Center for the Cardiovascular Cell Therapy Research Network (CCTRN). He is also past president of the American College of Cardiology (ACC). Raval is associate professor of medicine, division of cardiovascular medicine at the University of Wisconsin, where he practices as an interventional cardiologist conducting cardiovascular clinical trials for cell and biologic therapy. He is also director of cardiovascular clinical research and director of the Regional ST Elevation Myocardial Infarction Program. 

“CardiAMP has the potential to bring an effective therapy forward that will provide meaningful clinical benefit to patients with ischemic heart failure,” said Raval. “There is an enormous unmet need here, and CardiAMP is a worthy endeavor that has a high probability of meeting both the safety and the efficacy required to become a therapeutic option for heart failure patients.”

“CardiAMP builds on – and benefits from - what has been done in previous CCTRN trials in that it provides the highest effective dosage that has been studied in a rigorous trial to date, and the companion diagnostic selects patients that have potent autologous bone marrow,” said Pepine. “This trial pulls together everything we have learned in the field of autologous bone marrow cell therapy to treat heart failure. There are very promising signals in the Phase II data that we hope to see confirmed in the Phase III trial.”

Studies supporting the CardiAMP Therapy – including the Phase I Transendocardial Autologous Bone Marrow in Myocardial Infarction Study, which was published in Eurointervention, and the Phase I/II Transendocardial Autologous Cells in Heart Failure Trial, which was published in the Journal of the American Medical Association (JAMA) - showed statistically and clinically significant results. Trial results have demonstrated an excellent safety profile, as well as functional and quality of life improvements.

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