The Fast Track designation was granted on the strength of the evidence in the subset of patients that were responders at 9 month, further confirmed by the 12 months data recently presented. Celyad intends to leverage this designation to accelerate the search for a strategic partner.
FDA granted Fast Track designation for 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 as Fast Track Development Program.
Celyad’s C-Cure® therapy is one of the most advanced cell therapies in the heart failure segment. The CHART-1 trial has identified a sizeable patient population with a positive response to C-Cure®, and a better defined optimal dosing.
This was further validated by the 12 months data recently presented by Prof. John Teerlink at the late breaking session of the European Heart Failure Society meeting (Paris, Mays 1st, 2017), and accepted for publication in the European Journal of Heart Failure.
In December 2015 Celyad received clearance from the FDA for CHART-2, a prospective multi-centre, randomized, sham-controlled, Phase III pivotal study for C-Cure®. The company is in the process of identifying strategic partners to initiate the CHART-2 clinical trial.
Dr. Christian Homsy, CEO of Celyad: “While Celyad focuses its resources in 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. We hope, with the support of Piper Jaffray, to be able to identify a partner to carry the C-Cure program forward.”
The FDA’s Fast Track Drug Development Program is designed to expedite clinical development and submission of New Drug Applications (NDA) for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available. For more information on Fast Track, visit the FDA website (http://www.fda.gov).
