Mont-Saint-Guibert, Belgium – Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of regenerative, protective and reconstructive therapies, announces today the enrolment of the 240th patient in its CHART-1 European trial for C-Cure®, the first and only stem cell therapeutic using guided stem cells for the treatment of congestive heart failure.
With recruitment that started in mid-2013, Cardio3 BioSciences has enrolled 240 patients in less than 18 months, ahead of schedule. As usual in clinical trials targeting severe indications, the Company will continue to recruit additional patients in anticipation of patient dropouts. The CHART- 1 trial is currently ongoing in 12 countries in Europe and Israel.
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.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are extremely pleased to have enrolled the 240th patient of CHART-1, ahead of schedule. This represents a major achievement for the entire team involved in this trial and I am proud we succeeded in achieving this key operational objective this year. The CHART-1 trial remains solidly on track, with the interim futility readout scheduled for the end of March 2015 and the readout of the full dataset a year later. This accomplishment demonstrates our clinical expertise and gives us confidence for the upcoming CHART-2 trial, to be initiated soon in the U.S.”