BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure - Seite 2

In a subgroup analysis of patients with elevated NTproBNP at baseline – encompassing 59% of total enrolled randomized patients – patients treated with CardiAMP cell therapy experienced an 86.2% relative risk reduction in heart death equivalents and a 23.9% relative risk reduction in MACCE. These patients saw more than a 17% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (2.9% vs. 21.1%, respectively).

“These positive results for CardiAMP cell therapy are very encouraging, especially for patients with elevated NTproBNP, who encompass the majority of heart failure patients that we see in our daily practice,” said trial co-principal investigator Dr. Raval. “While the trial’s data safety monitoring board determined that the study would not meet its composite primary endpoint that included six-minute walk distance per the trial design, the positive results for reduced heart death equivalents, reduced MACCE, and safety indicate potential for this therapy to improve outcomes for patients with advanced chronic heart failure. Despite improvements with current medications and devices, heart failure remains at epidemic proportions and we now have an exciting opportunity for a therapy to improve important, objective outcomes, such as mortality and hospital re-admissions rates. I am excited to be part of a terrific team to validate the promise of this therapy in this high responder group in the follow-on trial that is now FDA-approved and soon to treat its first patient.”

“We thank the FDA for its speedy review and approval of the important follow-on Phase III trial. We are encouraged by the totality of today’s results and anticipate that both the final 24-month data analysis and follow-on trial outcomes would be consistent with this highly positive data,” said BioCardia CEO Peter Altman.

Also at the THT scientific meeting, first enrollment for the dose escalation safety phase of BioCardia’s Phase I/II study of the CardiALLO allogeneic mesenchymal stem cell (MSC) therapy in heart failure patients was reported. The cohort receiving the lowest dose of 20 million cells has been initiated with no treatment-emergent adverse events, arrhythmias, rejection, or allergic response. The first author of the study is R. David Anderson, MD, Professor of Medicine at the University of Florida at Gainesville. Following completion of the dose escalation safety phase of the study, a Phase II randomized double-blind controlled study is planned to assess efficacy.