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Kalytera Announces Initiation of Phase 2 Clinical Study in Prevention of Graft Versus Host Disease and Agreement with The Salzman Group of Israel to Manage and Partially Fund the Study to be Led by a World Class Team
Kalytera Announces Initiation of Phase 2 Clinical Study in Prevention of Graft Versus Host Disease and Agreement with The Salzman Group of Israel to Manage and Partially Fund the Study to be Led by a World Class Team.
About this update from Claritas Pharmaceuticals Inc.
[{"type":"text","content":"\n\n SAN FRANCISCO and TEL AVIV, Israel, Dec. 07, 2017 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX-V:KALY) and (OTCQB:KALTF) (the \"Company\" or \"Kalytera\") today announced the initiation of a Phase 2 clinical study evaluating the use of cannabidiol (\"CBD\") in the prevention of graft versus host disease (\"GVHD\").  Kalytera also announced today that it has entered into an agreement with The Salzman Group of Israel, under which The Salzman Group will, among other things, accept common shares of Kalytera in payment for its services in connection with the Phase 2 study, subject to TSX Venture Exchange approval.\n Initiation of Phase 2 Clinical Study in Prevention of Graft Versus Host Disease The Phase 2 study is designed to assess the pharmacokinetic and safety profile of multiple doses of CBD for the prevention of GVHD. The study is expected to enroll 36 patients following allogeneic hematopoietic cell transplantation, and will take place at Beilinson Hospital, and one other major medical center in Israel. Results of the study are expected by Q3 2018. The Company anticipates that, following completion of the Phase 2 study, it will initiate the Phase 3 study as quickly as possible. “We are focused on advancing this program from its current Phase 2 status to Phase 3 status as quickly and efficiently as possible, and the initiation of this Phase 2 study is an important and essential step in that process,” said Robert Farrell, President and CEO of Kalytera. The Principal Investigator of the study is Daniel Couriel, M.D., M.S., Director of the Bone Marrow Transplant Program at the University of Utah Health Sciences, School of Medicine. Other experts in the field of GVHD who will advise the Company with regard to the study include Edmund Waller, M.D., PhD., Professor, Hematology and Medical Oncology, Medicine, and Pathology at Emory University School of Medicine, and Director, Division of Stem Cell Transplantation and Immunotherapy at Winship Cancer Institute of Emory University; and Rafael Duarte, M.D., Ph.D., Director of the Haematopoietic Transplant Programme at the Catalan Oncology Institute in Barcelona. Agreement with The Salzman Group Kalytera also announced today that it has entered into an agreement with The Salzman Group (the “Agreement”), under which The Salzman Group will provide cl...