BioCardia Announces Interim Efficacy Results in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial - Seite 2

For the third-tier of change in Six Minute Walk Test (6MWT) distance from baseline to 12 months, both CardiAMP treatment patients and control patients experienced a clinically meaningful improvement at 12 months which was not statistically different. The treated group median 6MWT at 12M increased 36.1 with a standard deviation of ±70.8 meters, and the control group median 6MWT increased at 12M by 33.4 meters ± 74.8 meters (p =0.6). Results at 24 months also showed improvements in both groups with the treatment group median improving 1.8 ± 76.1 meters and the control group median improving 17.4 ± 95.7 meters (p=0.33). The improvement in 6MWT at 12M for the control group was greater than was expected in this population.

Based on these measures at one year follow-up, the 250-patient randomized controlled study is unlikely to meet its primary three-tiered FS efficacy endpoint, as seen from the initial 102 randomized patient set assessed at 12-month follow-up (110 patients had been randomized and eight of them had not completed their 12-month follow-up visit at the time of the analysis). This interim randomized study data does not include the study’s roll-in open label cohort of 10 patients treated who did well with 100% survival at two-year follow-up. These limited interim results related to the primary efficacy endpoint have been shared with the Co-National Principal Investigators of the study.

The study’s Co-National principal Investigator, Dr. Carl Pepine, MD, MACC, Professor of Medicine at the University of Florida at Gainesville, said, “I am pleased that the aggregate outcomes data show promising low rates of adverse outcomes for a cohort of over 100 subjects with HFrEF due to ischemic heart disease. Furthermore, the study is the first to demonstrate that it is feasible to ‘personalize’ therapy using a novel bone marrow cell population analysis, process the cells at the bedside, and safely administer them by a trans myocardial injection system.”

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.”