Gamida Cell was granted FDA Breakthrough Therapy Designation for NiCord, a novel graft modality for bone marrow transplantation.
On Oct. 11, 2016 Gamida Cell announced that FDA granted NiCord, an in development novel graft modality for bone marrow transplantation in patients with high-risk hematological malignancies, breakthrough therapy designation. In a press announcement, the company said the Phase III registration study of NiCord is planned to begin before the end of the year.
Data from the Pilot and Phase 1/2 studies of NiCord have demonstrated clinically meaningful improvement in time to neutrophil engraftment over cord blood transplantation. NiCord study data have shown fewer infections, reduced length of hospitalization, quicker platelet engraftment, and improved non-relapse mortality when compared with unmanipulated cord blood transplantation.
