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BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial
Adaptive Statistical Analysis Plan Recommended SUNNYVALE, Calif., Aug. 31, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular
About this update from Biocardia, Inc.
[{"type":"text","content":"Adaptive Statistical Analysis Plan Recommended SUNNYVALE, Calif., Aug. 31, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the ongoing Phase III pivotal CardiAMP® Cell Therapy Heart Failure Trial (clinicaltrials.gov Identifier: NCT02438306), for which FDA granted Breakthrough Designation earlier this year. The DSMB based their review on available data for all participating patients enrolled, including 101 patients at or past the 12-month primary endpoint. The DSMB performed a risk-benefit assessment, indicated no significant safety concerns, and recommended that the study continue as designed. The DSMB also recommended that BioCardia consider implementing an adaptive statistical analysis plan which could enable an early readout for study treatment efficacy. Patient visit data was available for 93% or more of all patients at all follow-up endpoints. Blinded results across all patients (including treated and control patients) are showing a survival rate at one year follow-up that is greater than that observed in recent similar large pivotal trials in patients with heart failure with reduced ejection fraction.1,2 For study subjects followed-up to date through the key visit dates in this study, mean health outcomes across both treated and control patients including six minute walk distance test, patient status assessed by New York Heart Association class, quality of life measured using the Minnesota Living with Heart Failure questionnaire, and heart function assessment such as left ventricular ejection fraction, are demonstrating favorable trends for meaningful clinical improvement. Whether the difference in outcomes between the two patient study groups enrolled and randomized into the current trial exists won’t be known until the data is unblinded and analyzed formally in accordance with the prespecified statistical analysis plan. “It is outstanding news that available blinded results show the trial integrity remains intact with few patients lost to follow-up visits. The phenomenal follow-up during these difficult times is to the credit of our dedicated clinical partners and the patients parti...