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Kalytera Receives IRB Approval for Proposed Phase 2 Study Evaluating CBD in the Prevention of Graft versus Host Disease
Kalytera Receives IRB Approval for Proposed Phase 2 Study Evaluating CBD in the Prevention of Graft versus Host Disease.
About this update from Claritas Pharmaceuticals Inc.
[{"type":"text","content":"\n\n SAN FRANCISCO, Calif. and TEL AVIV, Israel, Sept. 07, 2017 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE:KALY) (OTCQB:KALTF), a clinical-stage pharmaceutical company developing cannabinoid therapeutics for Graft versus Host Disease (“GvHD”), today announced that it has received approval from the Institutional Review Board (“IRB”) at one of two clinical sites in Israel to commence a Phase 2 study to evaluate cannabidiol (“CBD”) for the prevention of GvHD.\n The proposed study is a Phase 2, open label, multicenter trial to evaluate the pharmacokinetic profile, safety, and efficacy of multiple doses of CBD for the prevention of GvHD following allogeneic hematopoietic cell transplantation (“HCT”). The proposed study will take place at the Rabin Medical Center, Beilinson, and the Rambam Health Care Campus, Haifa, in Israel. Kalytera has received approval from the IRB at Beilinson to commence the Phase 2 study and expects to receive similar approval from the IRB at Rambam shortly. “This study is the next step in our development program designed to obtain FDA approval of CBD in the prevention of GvHD,” said Robert Farrell, President and Interim CEO of Kalytera. “The Phase 2 study is designed to generate the pharmacokinetic and safety data, at multiple dose levels, that will be required by the FDA as we seek to advance towards a pivotal Phase 3 clinical study.” Mr. Farrell continued, “Kalytera has assembled a world-class team to lead our program in the prevention of GvHD. The present Phase 2 study will be directed by Moshe Yeshurun, M.D., Director of the Bone Marrow Transplantation Department, Davidoff Center, Rabin Medical Center, Beilinson Hospital. Dr. Yeshurun will be the principal investigator of the study. Dr. Yeshurun was also the principal investigator in four prior clinical studies evaluating CBD in the prevention and treatment of GvHD that were conducted at Beilinson Hospital.” Dr. Yeshurun was advised in the design of the Phase 2 study by a team of experts in the field of GvHD, including Daniel Couriel, M.D., M.S., Director of the Bone Marrow Transplant program at the University of Utah Health Sciences, School of Medicine; Edmund Waller, M.D., PhD., Professor, Hematology and Medical Oncology, Medicine, a...