Exciting Times in Cardiology: Phase III Heart Failure Trial Casts Doubt on BioCardia’s Cell Therapy’s Primary Goal

California-based BioCardia dropped a bombshell on Tuesday, revealing that its cutting-edge cell therapy, CardiAMP, aimed at combating heart failure, may not achieve its primary goal, according to early data.

The plot thickened as an independent Data Safety Monitoring Board (DSMB) conducted a mid-course review, dissecting the three crucial components that form the therapy’s primary efficacy endpoint, after a year of treatment.

In a nail-biting showdown, the first component, measuring all-cause death, showed that 5.6% of patients receiving CardiAMP faced all-cause death or its equivalent, such as heart transplant or left ventricle assist device placement. In contrast, 5.3% of the control group experienced these life-altering events. The second component, involving non-fatal major adverse cardiac events, witnessed 16.7% of treated patients grappling with this challenge, compared to 15.8% in the control group.

But here’s where it gets intriguing—the six-minute walk test distance revealed something fascinating. Patients on CardiAMP showcased “clinically meaningful improvement at 12 months, which was not statistically different,” according to the company’s press release.

Digging deeper, the review hinted at silver linings on the horizon. When tracking all-cause death in patients who received therapy for up to 24 months, the figures shifted dramatically: 8.3% for the therapeutic group versus a staggering 13.2% for the control group. The tale continued with non-fatal major adverse cardiac events, holding steady at 16.7% for the therapy group but surging to 23.6% for the control group.

Despite these less-than-stellar results, BioCardia remains undaunted, armed with a wealth of data on autologous cell dosing from the study. They’re poised to scrutinize patient outcomes with a magnifying glass, paving the way for more personalized insights. Plus, these interim findings promise to shape ongoing development strategies for both CardiAMP and the allogeneic CardiALLO cell therapy programs.

BioCardia’s CEO, Peter Altman, had this to say: “We are actively engaged in identifying patients who responded the most to the therapy and are considering other learnings with respect to trial design to inform this program and our other two ongoing clinical programs.”

This revelation follows BioCardia’s earlier decision to halt enrollment in the trial, per the DSMB’s recommendation, pending a one-year follow-up. It was a move tied to the primary Finkelstein-Schoenfeld composite endpoint assessment and supplementary analysis, though the company stressed that this decision had no connection to any safety concerns.

The CardiAMP cell therapy program has dazzled with its approach, harnessing a patient’s own bone marrow cells to ignite a natural healing response within the heart. BioCardia has been exploring its potential in addressing a range of cardiac conditions, including the challenging realm of chronic myocardial ischemia.

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