BioCardia’s Cell Therapy Unlikely to Meet Primary Endpoint in Phase III Heart Failure

Pictured: An elderly man with his hand over his heart/iStock, Rawpixel

Pictured: An elderly man with his hand over his heart/iStock, Rawpixel

California-based BioCardia announced Tuesday that its clinical-stage experimental cell therapy for heart failure, CardiAMP, was unlikely to meet its primary endpoint based on preliminary data. 

An independent Data Safety Monitoring Board (DSMB) conducted an interim efficacy review of the three components that make up the primary efficacy endpoint for the therapy after one year of treatment.

The first component, all-cause death, showed 5.6% of patients taking CardiAMP suffered all-cause death or an equivalent, such as heart transplant or left ventricle assist device placement, versus 5.3% of the control. The second component, non-fatal major adverse cardiac events, 16.7% of the treated patients suffered this symptom, versus 15.8% of the control group.

Finally, for the six-minute walk test distance, patients taking CardiAMP experienced “a clinically meaningful improvement at 12 months which was not statistically different,” the company said in the release.

The review also did note, however, that there were improvements in longer-term follow-up. All-cause death in patients taking the therapy for up to 24 months was 8.3%, versus 13.2% in the control group. And for non-fatal major adverse cardiac events, the incidence remained steady for the therapeutic group at 16.7%, but increased to 23.6% in the control group.

Though the results are not promising, the company noted in the release that it has “significant data for the autologous cell dosing as performed in the study procedure, enabling assessments of efficacy on a patient-by-patient basis, which we will study.”

The company also noted that “knowledge from these interim details may be incorporated in its ongoing development plans for its autologous CardiAMP and allogeneic CardiALLO cell therapy programs.”

“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,” BioCardia CEO Peter Altman said in a statement.

The news comes not long after BioCardia told investors that it was pausing enrollment in the trial on the recommendation of the independent DSMB pending the one-year follow-up, based on “the primary [Finkelstein-Schoenfeld] composite endpoint assessment and a supplemental analysis,” but noted the recommendation was “unrelated to any emergent safety events.”

The CardiAMP cell therapy program works by bringing a patient’s own bone marrow cells to the heart to induce a natural healing response. The company is investigating its potential in treating a variety of cardiac conditions, including chronic myocardial ischemia.

Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at

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