BioCardia Pauses Patient Enrollment in Pivotal Phase 3 Cardiac Trial

BioCardia, Inc., (Nasdaq: BCDA) has paused enrollment of patients in its Phase 3 pivotal clinical trial evaluating CardiAMP® as a treatment for heart failure on the recommendation of its independent Data Safety Monitoring Board (DSMB). The DSMB’s initial analysis of the unblinded data concluded that the trial was unlikely to meet its primary FS composite endpoint.

The FDA previously granted Breakthrough Designation to BioCardia’s  CardiAMP® Cell Therapy Heart Failure Trial.

BioCardia CEO Peter Altman, Ph.D., said, “We look forward to enabling the DSMB to have the requested analysis at twelve-month follow-up. We are pleased that there appear to be no treatment emergent safety issues and that the health outcomes measured in the trial show improvement for patients as a group.”

Highlights

BioCardia will pause the trial pending the one-year follow-up outcomes analysis for patients that have been treated and those that have been enrolled but not yet treated.

CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response.

BioCardia’s DSMB panel includes two cardiologists with experience in heart failure and interventional cardiology and a biostatistician experienced in evaluating trial data for chronic diseases, including heart failure.

The DSMB’s role is to ensure patient safety and to promote/monitor the quality and integrity of the data. The DSMB interim review was based on available data for 132 procedures involving 111 randomized patients, including treated patients and the control group.

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and NK1R+ allogeneic cell therapies are the Company’s biotherapeutic platforms that enable four product candidates in development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough Designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS Reimbursement.   BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information visit: www.biocardia.com.

Share This Article

 

About the Author

BioCardia Pauses Patient Enrollment in Pivotal Phase 3 Cardiac Trial

Editor Prism MarketView