Benzinga | Dec 17, 2020 08:34AM EST

BioCardia Announces Announces Positive DSMB Review And Recommendation To Continue Phase III Pivotal CardiAMP Heart Failure Study As Designed

SAN CARLOS, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- BioCardia (NASDAQ:BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP(tm) Heart Failure Trial. The DSMB based its review on all available data for the 86 patients enrolled in the trial, including 60 randomized patients who have reached their one-year follow-up. The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed.



"I am delighted with the positive recommendation from the distinguished CardiAMP DSMB to continue this important study," said BioCardia CEO Peter Altman, PhD. "The successful risk-benefit review is a testament to the dedication of the many CardiAMP investigators and clinical teams at leading institutions across the U.S. The DSMB was able to review the primary efficacy data from twice as many patients at one-year follow-up as were available in our Phase II study to arrive at their positive recommendation, with no change or action required. We believe that the DSMB recommendation further enhances the probability of our clinical cell therapy program becoming a valuable therapy for millions of patients suffering from cardiac disease."

"In addition to the DSMB report, we are enthusiastic about the significant momentum we are seeing in CardiAMP HF Trial enrollment, with a dozen patients currently in the pipeline for randomization. The trial is also generating compelling data on the high CD34+ cell dosage being studied that we intend to submit to an upcoming scientific conference or journal for publication," Altman added.

The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide. The trial's primary endpoint is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis, an established outcomes design that has been used in other leading heart failure programs. The FS procedure is a ranked analysis that first compares each subject to each other subject for occurrence of first-tier events (time to death, in this case) and then compares patient outcomes for subsequent tiers. The tiers, starting with the most serious events, would be (1) all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), excluding those deemed procedure-related occurring within the first seven days post-procedure (heart failure hospitalization, stroke or myocardial infarction), ordered by time to event; and (3) change from baseline in Six Minute Walk Distance at 12 months. Data submitted to the DSMB provided the group with visibility into the risks and benefits of the trial at its primary endpoint.

The DSMB consists of two world renowned cardiologists with experience in heart failure and interventional cardiology, as well as a world renowned biostatistician with considerable experience evaluating trial data for chronic diseases, including heart failure. Their primary responsibility is to ensure patient safety and to halt or pause the clinical investigation if the risk of the therapy appears to outweigh its potential benefit. Such risk-benefit analysis typically includes an analysis of futility to reach the primary endpoint of the clinical trial as designed.

Patients interested in learning about the study can visit www.cardiamp.com or www.clinicaltrials.gov for more information.