Celyad has received Fast Track Designation from the FDA for C-Cure, a cell therapy aimed to treat heart failure with the patient’s own stem cells.
Celyad is confident that the announcement of Fast Track Designation from the FDA will help it accelerate the search for a partner to develop C-Cure, a cell therapy for ischemic heart failure. After running a Phase III trial in Europe that didn’t meet its primary endpoint, the Belgian biotech identified a subpopulation of more of 60% of patients that did show a significant improvement and is now determined to try again once it finds financial support.
Celyad’s C-Cure technology consists in the harvest of the patient’s bone marrow, which is treated with growth factors and then re-injected into the heart to grow new functional muscle in the area lost due to infarction. The therapy is complementary to Celyad’s main focus, immuno-oncology. The company is well-known for developing an allogeneic version of the promising CAR-T technology that recently triggered a license agreement with Novartis.
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