Green Light for BioCardia Study Following Interim Safety Analysis

Cardiovascular Regenerative therapies company, BioCardia tells us that the independent Data Safety Monitoring Board (DSMB) has indicated there were no significant safety concerns with the CardiAMP study results and recommended that the trial continue, as planned.

Background

CardiAMP therapy is designed to stimulate the body’s natural healing response. It delivers a high target dose of 200 million mononuclear cells directly to injured cardiac tissue using a proprietary delivery system. A few weeks ago we covered the news that the so-called Helix™ transendocardial delivery system had been deemed safe following positive 12-month results from its Phase II TRIDENT clinical trial.

With the positive news from the DSMB, the ongoing 260 patient trial can now continue. This multi-center, double-blinded, randomized (3:2), sham-controlled Phase 3 trial will evaluate CardiAMP cell therapy in adult patients with heart failure that develops following a heart attack.

The trial’s primary efficacy endpoint is a significant improvement in Six Minute Walk distance at 12 months post-treatment. It also incorporates the impact of major adverse cardiac events and other clinically meaningful events.

Investigator comments

Amish Raval, MD, associate professor of cardiovascular medicine for the University of Wisconsin School of Medicine and Public Health, and co-national principal investigator for the ongoing CardiAMP Heart Failure Trial, stated, “The CardiAMP cell therapy program has hit another very important milestone. This minimally invasive, point of care approach has the potential to revolutionize the treatment of ischemic heart failure. We are now recruiting for the randomized, controlled pivotal trial, which is designed to test the hypothesis that transendocardial delivery of autologous bone marrow mononuclear cells to patients, who are pre-selected with high bone marrow potency markers, will improve Six Minute Walk distance and other clinically relevant endpoints.”

Company comments

“This is a major achievement for BioCardia and our personalized CardiAMP cell therapy program,” said BioCardia CEO Peter Altman. “We are focused on addressing the growing problem of heart failure, which affects almost six million adults in the U.S. and costs the healthcare system more than $30 billion each year.”

Source: BioCardia, Inc.

 

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