Fate Therapeutics Announces First Patient Treated in ProTmune Protect Clinical Trial for the Prevention of Graft-Versus-Host Disease
January 05, 2017 at 08:00 am EST
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Fate Therapeutics, Inc. announced that the first patient has been treated in its PROTECT clinical trial of ProTmune for the prevention of acute graft-versus-host disease (GvHD). GvHD is a severe immunological complication that arises in patients when newly-transplanted donor immune cells attack the patient’s tissues and organs, resulting in a potentially fatal immune system reaction. Despite the use of protocols to prevent its occurrence, up to 50% of patients undergoing allogeneic hematopoietic cell transplantation (HCT) experience GvHD. Immunosuppressant treatments are effective in only about half of affected HCT patients and are associated with a marked increase in severe infections and cancer relapse. The PROTECT clinical trial is designed as a two-stage study intended to evaluate the safety and efficacy of ProTmune in adult subjects with hematologic malignancies. The Phase 1 stage is assessing the safety of ProTmune in up to 10 subjects. The randomized, controlled Phase 2 stage is intended to assess the efficacy of ProTmune in 60 subjects. In late 2016, the Company amended the PROTECT study’s clinical protocol to blind both investigators and subjects, enhancing the potential of the PROTECT study to support accelerated registration.
Fate Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Its proprietary induced pluripotent stem cells (iPSC) product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. The Companyâs platform is designed to overcome numerous limitations associated with the manufacture of cell therapies using patient- or donor-sourced cells. Utilizing its proprietary iPSC product platform, it is advancing off-the-shelf, multiplexed-engineered natural killer (NK) cell and T-cell product candidates which are selectively designed, incorporate novel synthetic controls of cell function. Its pipeline of iPSC-derived, chimeric antigen receptor (CAR)-targeted NK cell and T-cell product candidates include FT819, FT522, FT576, FT825, FT819, FT522, and others.