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Fate Therapeutics Initiates Phase 2 Clinical Study of ProHema for the Treatment of Hematologic Malignancies
Date:11/27/2012

SAN DIEGO, Nov. 27, 2012 /PRNewswire/ -- Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators, announced today the initiation of a randomized, controlled, Phase 2 multi-center study of its investigational hematopoietic stem cell therapy, ProHema, in adult patients undergoing double umbilical cord blood transplantation (dUCBT) for hematologic malignancy.  The advancement of ProHema into later-stage development builds upon positive results from a Phase 1b single-center study, interactions with the U.S. Food and Drug Administration and refinements to the product manufacturing process.  The previously completed Phase 1b study achieved its primary objective of demonstrating safety and tolerability.  The study also established early clinical proof-of-concept – trends of accelerated neutrophil recovery, improved 100-day survival and low rates of graft-versus-host disease were evident, and durable and preferential reconstitution with ProHema occurred in 10 of 12 evaluable patients.  ProHema is produced through a proprietary, two-hour, ex vivo modulation process, which has been shown to significantly activate key biological pathways involved in hematopoietic stem cell homing, proliferation and survival in preclinical models.

"Allogeneic umbilical cord blood transplantation holds great promise as a potentially curative treatment for children and adults with hematologic malignancies and many other life-threatening, non-malignant disorders," said Christian Weyer, M.D., M.A.S., President and Chief Executive Officer of Fate Therapeutics.  "ProHema is being developed with the intent to improve outcomes in patients undergoing cord blood transplantation by facilitating both accelerated engraftment and durable reconstitution using a simple, point-of-care, ex vivo modulation process. The initiation of Phase 2 marks an important milestone for the company and bri
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SOURCE Fate Therapeutics, Inc.
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