Cell therapy for heart failure receives FDA Fast Track Designation
C-Cure®, from Celyad, is designed to enhance the reparative capabilities of the heart and will shortly be the focus of a Phase III pivotal study.
A cell therapy to treat heart failure is the latest to receive the FDA’s Fast Track Designation. This designation recognizes the therapy as having the potential to treat serious or life-threatening conditions and address unmet medical needs, and facilitates regular interaction with the FDA review team to expedite clinical development and submission of a New Drug Application.
C-Cure®, from Celyad (Belgium), consists of autologous bone marrow cells treated with a combination of cytokines and growth factors that are then re-injected into the heart. The Fast Track designation was granted for a reduction in mortality, hospitalization and improvement of quality of life in patients with chronic heart failure secondary to ischemic cardiomyopathy with baseline Left Ventricular End-Diastolic Volumes (LVEDV) between 200 and 370ml.
Christian Homsy, CEO, Celyad, explained that “while Celyad focuses its resources on the development of our immuno-oncology platform, receiving Fast Track Designation is an important milestone for C-Cure and is a testimony to the quality of the science and the strength of the 9 and 12 months CHART-1 data.”
Celyad received clearance from the FDA for a prospective multi-centre, randomized, sham-controlled, Phase III pivotal study for C-Cure in December 2015. CHART-2 will be initiated once suitable strategic partners have been identified.