Decision supports continuation of Phase III trial evaluating treatment for congestive heart failure
Mont-Saint-Guibert, Belgium – Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in engineered cell therapy treatments, today announced the successful completion of a futility analysis for C-Cure®, its lead cell therapy for congestive heart failure, currently being evaluated in a Phase III clinical trial in Europe and Israel (CHART-1).
The Data Safety and Monitoring Board (DSMB), an independent committee comprised of international experts, reviewed unblinded safety and efficacy data from CHART-1 and determined that such data did not support discontinuation of the trial on the basis of safety or futility and recommended that it continue without changes to the protocol.
A futility analysis tests the inability of a clinical trial to achieve its efficacy objective. Therefore, a conclusion that a trial is not futile suggests that a clinical trial has the potential to achieve its stated efficacy objective.
The DSMB analysis was performed after all patients were enrolled in the trial. Prior to this futility analysis, CHART-1 completed all safety data reviews by the DSMB, indicating that there is no major or unexpected safety concern with C-Cure® in the target patient population.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “The positive recommendation from the DSMB is an important milestone for our Phase III clinical trial of C-Cure®, and we are extremely pleased to see that interim data supports the continuation of the trial on its initial assumptions. With the successful completions of both patient recruitment and this futility analysis, Cardio3 BioSciences can focus on further advancing the CHART-1 trial and, pending successful primary endpoint readout expected in the middle of 2016, initiating the registration process for C-Cure® in Europe”.
CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) is a patient prospective, controlled multi-centre, randomized, double-blinded Phase III clinical trial comparing treatment with C-Cure® to a sham treatment. The trial has recruited 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at nine months post-procedure. The next milestone in the clinical trial will be the release of the full clinical data set, anticipated for the middle of 2016.