Mont-Saint-Guibert, Belgium – Celyad SA (Euronext Brussels, Euronext Paris and Nasdaq: CYAD), a leader in the discovery and development of engineered cell therapies, today announced that it has completed the injection procedure for the last patient enrolled in CHART-1, its European Phase III clinical trial for its lead cardiovascular disease product candidate, C-Cure®.
C-Cure® is an autologous cell therapy intended to guide cardiac tissue formation in patients with ischemic heart failure by harvesting the patient’s own multipotent stem cells, reprograming these cells into cardiopoetic cells and re-injecting these reprogrammed cells back into the patient. With the final injection procedure completed, Celyad has initiated the nine-month follow-up period for this patient. The Company expects to release the full clinical data set for CHART-1 in the middle of 2016.
Dr. Christian Homsy, CEO of Celyad, commented, “Completing the injection procedure on the last CHART-1 patient represents another significant clinical development milestone for this product candidate and affirms so far our ability to meet operational timelines. It follows the positive outcome of the futility analysis performed on a subset of patient data in the first quarter and brings us an important step closer to potentially bringing this innovative treatment forward to help heart failure patients. We look forward to reporting the full CHART-1 data set in the middle of 2016.”
The CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) trial is a Phase III clinical trial to evaluate a cellular therapy for the treatment of heart failure. CHART-1 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 in 12 countries in Europe and Israel. The trial is designed to assess the safety and efficacy of C-Cure®. 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.
C-Cure® is Celyad’s most advanced product candidate based on its cardiopoiesis platform and is being developed for heart failure indications. The research underlying this technology was originally conducted at Mayo Clinic by the research team of Professor André Terzic and Atta Behfar, and has been published in numerous peer-reviewed publications. C-Cure® consists of a patient’s own cells harvested from bone marrow, treated with cardiopoietic growth factors and then re-injected into the heart. It is designed to produce new autologous heart muscle cells which behave identically to those lost as a result of infarction, without the risk of rejection.
C-Cure®’s potential has been demonstrated in a multi-centre randomized controlled Phase II trial conducted in Europe. The results of the C-Cure® Phase II trial were published in April 2013 in the Journal of American College of Cardiology.