Mont-Saint-Guibert, Belgium, – Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of advanced regenerative therapies for heart disease, announces today that it has enrolled the 120th patient in its phase III clinical study CHART-1, aimed at evaluating the potential of its product candidate C-Cure® for the treatment of heart failure. This represents the half of patients to be recruited into CHART-1.
With over 25 active centers in 10 countries, the Company is in line with its goal of completing the recruitment of all patients by the end of 2014.
CHART-1 is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial will recruit a minimum of 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 9 months post-procedure. This study represents the world’s first Phase III trial for a pre-programmed cellular therapy targeting heart failure.
To date, no incidents reported in the study call into question the continuation thereof. The safety analysis during the third quarter and futility analysis around the end of this year are the next steps in the study.
Dr Christian Homsy, CEO of Cardio3 BioSciences, comments: “We are very pleased to announce the recruitment of the 120th patient that keeps us on target with our goal of enrolment. This is an important milestone that demonstrates the momentum seen into the start of 2014. Everyday, thanks to the commitment of our teams and clinical centers that combine enthusiasm and competence, we are coming closer to our goal which is to bring a totally new and different treatment to thousands of patients suffering from heart failure.”