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

ngs us one step closer towards achieving this objective."

The Phase 2 study is expected to enroll at least 45 adult patients undergoing dUCBT for the treatment of hematologic malignancies.  Patients will be randomized, with a ratio of 2:1, to receive either ProHema plus an unmanipulated cord blood unit or two unmanipulated cord blood units.  The study will evaluate time to neutrophil and platelet recovery, incidence of serious infections and graft-versus-host disease, 100-day mortality and relative dominance of ProHema over the unmanipulated cord in contributing to reconstitution.  Results are expected in 2013.

"The preclinical and clinical data obtained to date suggest that ProHema may address several of the unmet medical needs in the evolving field of hematopoietic stem cell transplantation," said Steven Devine, M.D., Professor of Medicine and Program Director of the Blood and Marrow Transplant Program at the Ohio State University and a principal investigator of the Phase 2 clinical study.  "While further investigation is required, an intervention that enables early and durable reconstitution of the best-HLA-matched cord blood unit has the potential to improve patient outcomes and substantially enhance the therapeutic value proposition of cord blood transplant."

About ProHema

ProHema is an innovative cord blood-derived cell therapy containing pharmacologically-modulated hematopoietic stem cells (HSCs).  ProHema is produced through a proprietary, two-hour, ex vivo cell modulation process that results in rapid activation of key biological pathways involved in homing, proliferation and survival of HSCs.  In preclinical testing, ProHema has demonstrated the potential to accelerate engraftment and to drive durable hematopoietic reconstitution, without the need for multi-week expansion protocols.  In an initial Phase 1b study in adult patients with hematologic malignancies undergoing double umbilical
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SOURCE Fate Therapeutics, Inc.
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