Benzinga | Jun 23, 2021 08:12AM EDT

BioCardia Reports Completion Of Fourth Data Safety Monitoring Board Review For Its CardiAMP Cell Therapy Heart Failure Trial; DSMB Indicated No Safety Concerns, Recommended Study Continue As Designed

BioCardia(r), Inc. (NASDAQ:BCDA), a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP(tm) Cell Therapy Heart Failure Trial (ClinicalTrials.gov Identifier: NCT02438306). The DSMB based its review on all available data for the 97 patients enrolled in the trial to date, including many who have reached their one-year, and a few who have reached their two-year, follow-up. The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed.

"This DSMB recommendation to continue the Phase 3 study suggests we are still heading in the right direction from both a safety and efficacy perspective," said BioCardia CEO Peter Altman, PhD. "CardiAMP Cell Therapy HF Trial enrollment remains a top priority as we begin to have the first control patients eligible for cross over to receive therapy. An earlier cross over recently approved by the FDA based on previous DSMB reviews, provides control patients with a much higher level of assurance that if they are eligible for the investigational therapy, they will be able to receive it after two years. This is good news for patients who participate out of the goodness of their hearts to contribute to the advancement of medical care and for the chance of receiving potential benefits to their own hearts from the CardiAMP investigational cell therapy."

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 compares occurrence of cardiovascular and other health-related events, along with functional capacity measures, through one year in patients receiving the study treatment to patients in the control arm who don't receive the study treatment. 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.