BioCardia has paused enrollment in a pivotal study of its stem cell therapy for heart failure after an independent review board determined the trial was not likely to succeed.
The Sunnyvale, CA-based biotech said Monday morning that the data and safety monitoring board (DSMB) reviewed an interim readout of the Phase III trial of its stem cell therapy for systolic heart failure. The board determined it was “unlikely to meet” the primary efficacy endpoint, a composite measure of survival, major cardiac events (such as heart attacks) and results from a six-minute walk test at one year.
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