Celyad Receives FDA Clearance on Its CHART-2 Phase III IND

Celyad CYAD today announced that the U.S. Food and Drug Administration (FDA) has authorized the Company's Investigational New Drug (IND) application to proceed thus allowing for the clinical testing of Celyad's lead cardiology candidate (C-Cure cardiopoietic cells) delivered via the proprietary catheter (C-Cathez) in the Phase III Heart Failure Trial (CHART-2) in the US. CHART-2 is intended to assess the efficacy of C-Cure as a treatment for heart failure of ischemic origin. CHART-2 is designed as a prospective, multi-centre, randomized, sham-controlled, patient- and evaluator-blinded Phase III study comparing treatment with C-Cure to a sham treatment. The trial is aimed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. Dr. Christian Homsy, Chief Executive Officer of Celyad: "CHART-2 study using Celyad's lead cardiology candidate (C-Cure cardiopoietic cells) delivered via our proprietary catheter (C-Cathez) will allow us to expand our Phase III clinical program and allow US clinical sites and patients to participate in our trials. We also expect that our fully See full press release