Posted by Michael Wonder on 03 Jul 2018
Cellerant Therapeutics announces FDA grants regenerative medicine advanced therapy designation for romyelocel-L to prevent infections during neutropenia
2 July 2018 - RMAT designation confers similar advantages as breakthrough therapy designation.
Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for romyelocel-L (human myeloid progenitor cells) for the prevention of serious bacterial and fungal infections in patients with de novo acute myeloid leukaemia (AML) undergoing induction chemotherapy.
Romyelocel-L is Cellerant’s universal, off-the-shelf cell therapy which does not require HLA matching. Neutropenia is a major side effect of myelosuppressive chemotherapies such as induction therapy and leaves patients at high risk of serious, often life-threatening infections.
The FDA granted RMAT designation based on Cellerant’s randomized, controlled Phase 2 trial of romyelocel-L in newly diagnosed AML patients who underwent induction chemotherapy. Results from the trial showed that romyelocel-L reduced the incidence of bacterial and fungal infections and days in the hospital. Cellerant intends to advance romyelocel-L to a pivotal Phase 3 clinical study.
