USFDA Grants RMAT Designation for Romyelocel-L to Prevent Infections During Neutropenia

Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, announced that the US Food and Drug Administration (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 leukemia (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 grants RMAT designation to regenerative medicine therapies if the therapy is intended to treat a serious or life-threatening condition and there is preliminary clinical evidence that the therapy could address unmet medical needs for such condition. The RMAT designation provides similar advantages as breakthrough therapy designation, including early interactions with the FDA to discuss potential ways to accelerate the development of a therapy towards regulatory approval. “Receiving RMAT designation for romyelocel-L is an important milestone and recognition by the FDA of the potential of romyelocel-L to serve this unmet medical need,” said Ram Mandalam, President and CEO of Cellerant. “We look forward to working with the FDA to advance development of romyelocel-L.”

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. – Medical Buyer Bureau