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

(RTTNews) - Celyad (CYAD), engaged in the discovery and development of engineered cell therapies, said the U.S. Food and Drug Administration has authorized the company's Investigational New Drug application on Its CHART-2 Phase III study to proceed.

This allows for the clinical testing of Celyad's lead cardiology candidate, C-Cure cardiopoietic cells, delivered via the proprietary catheter or C-Cathez in the Phase III Heart Failure Trial, CHART-2, in the U.S.

CHART-2 is intended to assess, the efficacy of C-Cure as a treatment for heart failure of ischemic origin.

It 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.