The DSMB (Data Safety and Monitoring Board), a committee composed of international independent experts, unanimously recommends continuing the study according to the original protocol, after having analyzed safety data relating to C-Cure® and C-Cathez® in the ongoing Phase III clinical trial conducted in Europe and Israel
Mont-Saint-Guibert, Belgium – Cardio3 BioSciences SA (C3BS) (NYSE Euronext Brussels and NYSE Euronext Paris: CARD), leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, today announces it has received the recommendation of the Data Safety and Monitoring Board (DSMB) to continue the CHART-1 clinical trial according to the original protocol. The recommendation is based on a planned analysis performed on all patient safety data available as per mid-August 2014.
The Data Safety and Monitoring Board is an independent committee composed of independent international experts in charge of safety evaluation of C-Cure® and C-Cathez® in the CHART-1 Phase III clinical trial currently underway in several countries in Europe and in Israel. The DSMB analyzed safety data 1-month post treatment of all patients randomized in the trial.
The CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) trial represents the world’s first Phase III trial for a pre-programmed cellular therapy for the treatment of heart failure.
The members of the DSMB approved unanimously the continuation of the trial having concluded that one month post treatment, C-Cure® and C-Cathez® shows no safety issue that compromises the continuation of the CHART-1 Phase III study.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are very pleased by the unanimous recommendation of the DSMB to continue to pursue CHART-1. This planned analysis is a significant step in our Phase III program and the positive outcome confirms all the confidence placed in the trial by our partners and investors. CHART-1 continues to progress well and the positive view of the DSMB will add further impetus to recruitment which we look forward to completing on schedule by the end of 2014.”
The Phase III trial 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 nine months post-procedure.