Fate Therapeutics Begins Phase 2 Study Of PROHEMA For Hematologic Malignancies

(RTTNews) - Fate Therapeutics Inc. (FATE) reported the enrollment of the first patient in its PROHEMA in UMbilical cord blood transplant in Adults or "PUMA" study, a Phase 2 trial of PROHEMA using the company's nutrient-rich media formulation.

The PUMA trial is designed to evaluate the efficacy and safety of PROHEMA in a randomized, controlled setting in patients undergoing hematopoietic stem cell or HSC transplantation to treat hematologic malignancies.

The trial is approved for conduct at 10 major HSC transplant centers in the U.S. Safety reviews are intended after six and 12 subjects, respectively, after being treated with PROHEMA in the PUMA trial, and the firm plans to issue a clinical update upon the completion of these reviews. Full data relating to the primary efficacy endpoint are anticipated in mid-2015.

Fate Therapeutics has closely worked with the FDA over the past 9 months to enable the clinical manufacture of PROHEMA using its NRM formulation for the PUMA study.