BioCardia (NASDAQ:BCDA) has announced the completion of its pre-specified data review for its third phase pivotal CardiAMP™ Heart Failure Trial. The independent Data Safety and Monitoring Board (DSMB) completed the review based on available data from all the 86 patients enrolled in the study, including the 60 randomized subjects that have reached the one-year follow up. The DSMB conducted a risk-benefit assessment in which they didn’t find any safety concerns and recommend continuing the study as previously designed.
BioCardia to continue trail as previously designed
Peter Altman, the company’s CEO, indicated that he is pleased with the positive recommendation from the DSMB to continue the study. Altman said that the successful risk-benefit review indicates the CardiAMP investigators and clinical teams’ dedication. He added that the DSMB managed to review the primary efficacy data from one-year follow-ups to come up with the recommendation without any change. The CEO said that the DSMB recommendation enhances the company’s clinical cell therapy program’s probability is a valuable therapy for cardiac disease patients.
Besides the DSM report, the company is delighted about the massive momentum it has witnessed in the CardiAMP HF Trial enrolment. Altman added that the trial is also creating significant data in the high CD34+ cell dosage that the company is studying.
Trial to enroll 260 patients
The ongoing multi-center randomized, double-blinded placebo-controlled CardiAMP Heart Failure Trial will enroll 260 patients in 40 centers. The study’s primary endpoint will be outcomes composite score based on the three-tiered Finkelstein-Schoenfeld hierarchical system. The system is an established outcomes design that has been applied in leading heart failure trials. The data submitted to the DSMB gave the group visibility into the study’s risks/benefits at its primary endpoint.
Most important, the DSMB comprises two top world cardiologists with considerable experience in interventional cardiology and heart failure. The DSMB’s primary role is to ensure patient safety and pause or stop clinical trials if the risks paused outweighs potential benefits.