BioCardia: Review shows candidate unlikely to meet endpoints

Dr. Amish Raval, MD, Professor of Medicine at University of Wisconsin at Madison and Co-National Principal Investigator, said, “Although the trial interim efficacy results show that the trial is unlikely to achieve its primary endpoint at one year, these results show that, while not statistically significant, there were trends towards patient benefits for the CardiAMP cell therapy over the course of the study, including a reduction in all cause death, including heart death equivalents and MACCE. I congratulate the study investigators on the absence of treatment emergent safety concerns.”

There were additional prespecified outcome measures detailed in the comprehensive SDAC closed session report. We also have 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. 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,” said Peter Altman, BioCardia President and CEO. “We anticipate working with the Principal Investigators and Executive Steering committee on these efforts. In parallel we expect to support centers as they complete treatment of previously enrolled patients in the next six weeks and follow these patients in a double blinded fashion as guided by the DSMB.”

https://www.biospace.com/article/releases/biocardia-announces-interim-efficacy-results-in-phase-iii-pivotal-cardiamp-cell-therapy-heart-failure-trial/