Fate Therapeutics' Prohema in Phase II Study - Analyst Blog

Fate Therapeutics, Inc. FATE announced that it has enrolled the first patient in its phase II study (PUMA − Prohema in UMbilical cord blood transplant in Adults) on Prohema.

Prohema, the lead candidate at Fate Therapeutics, is a pharmacologically modified hematopoietic stem cell therapeutic derived from umbilical cord blood. The open-label, randomized, controlled multi-center study will evaluate the efficacy and safety of Prohema, when enhanced with a nutrient-rich media formulation (NRM formulation), in patients undergoing hematopoietic stem cell HSC transplantation for the treatment of hematologic malignancies.

Fate Therapeutics intends to conduct safety reviews on the study following the completion of treatment of 6 and 12 patients, respectively, with Prohema. The company said that it will provide an update on the study after these reviews are completed. Data related to the primary efficacy endpoint of the study should be out in mid-2015.

Meanwhile, Fate Therapeutics is working on strengthening its pipeline candidates. This year, the company expects to file an Investigational New Drug application IND for a proprietary Wnt7a protein analog to evaluate its safety and efficacy in promoting muscle regeneration. Additionally, Fate Therapeutics intends to conduct studies on Prohema for hematopoietic reconstitution in both hematologic malignancies and lysosomal storage disorders (LSDs) in pediatric patients.

Fate Therapeutics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma sector include Alexion Pharmaceuticals, Inc. ALXN, Gilead Sciences Inc. GILD and Biogen Idec Inc. BIIB. While Alexion and Gilead Sciences carry a Zacks Rank #1 (Strong Buy), Biogen holds a Zacks Rank #2 (Buy).