Belgian biopharmaceutical firm Celyad has secured fast-track designation from the US Food and Drug Administration (FDA) for its C-Cure® therapy for patients with chronic heart failure, secondary to ischemic cardiomyopathy with baseline Left Ventricular End-Diastolic Volumes (LVEDV) between 200ml and 370ml as a Fast-Track Development Programme.
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The fast-track status is for reduction in mortality, hospitalisation and improvement of quality of life in patients affected with this disease.
Celyad CEO Dr Christian Homsy said: “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 nine 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 programme forward.”
The company claims that its C-Cure therapy is one of the most advanced cell therapies for heart failure.
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By GlobalDataThe CHART-1 trial has demonstrated that a sizeable patient population have showed positive response to C-Cure.
The 12 months data recently presented by Professor John Teerlink further confirmed the trial results and was 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, randomised, sham-controlled, Phase III pivotal study for C-Cure.
The company is currently looking for strategic partners to start the CHART-2 clinical trial.
The FDA's Fast-Track Drug Development Programme expedites clinical development and submission of New Drug Applications (NDA) for medicines indicated to treat life-threatening conditions.
Image: Coronary Artery Disease (ischemic heart disease). Photo: courtesy of BruceBlaus.
