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Kalytera to Conclude Phase 2 Clinical Study and Initiate Phase 3 Study
Kalytera to Conclude Phase 2 Clinical Study and Initiate Phase 3 Study.
About this update from Claritas Pharmaceuticals Inc.
[{"type":"text","content":"\n SAN FRANCISCO and TEL AVIV, Israel, Aug. 19, 2019 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF) (the \"Company\" or \"Kalytera\") today announced that interim results from the Company’s Phase 2 clinical study evaluating cannabidiol (“CBD”) for the prevention of acute graft versus host disease (“GVHD”) are significantly positive, and, as a result, the Company will not enroll the high dose cohort in its ongoing Phase 2 study, but will instead proceed directly to initiate a Phase 3 clinical registration study. Significance of Phase 2 Data in Prevention of Acute GVHDThe Company’s Phase 2 clinical study was designed in accordance with input received from the U.S. FDA. The study is fully GCP compliant. The CBD drug utilized in the study was produced in full compliance with GMP guidelines, and the analyses of samples from the study have been performed using validated methods in a fully compliant GLP facility. The Phase 2 study is focused on the most difficult of all patients at risk for acute GVHD: those receiving bone marrow transplants from matched unrelated donors. Because of the inherent differences between unrelated individuals, patients receiving bone marrow transplants from matched unrelated donors experience an incidence of grades 2-4 acute GVHD in the range of 60% - 70%. This level of disease is profoundly significant: in fact, in patients with grades 3 and 4 acute GVHD the mortality rate in the first several months after diagnosis is greater than 70% (for grade 3) and more than 95% (for grade 4). Prevention of acute GVHD is accordingly a significant unmet medical need, and a major goal of modern bone marrow transplantation medicine. In the Company’s Phase 2 study, the incidence of grades 2-4 acute GVHD observed to date in the low dose and medium dose cohorts are much lower than historic norms. Only 1 of 12 patients in the low dose cohort (8%) developed grade 2-4 acute GVHD after 180 days of observation, and in the medium dose cohort, no patients to date have developed grades 2-4 acute GVHD. The Company believes that these results are unprecedented, highly significant, and could signal a paradigm shift in the treatment of bone marrow transplant patients. The Company plans to submit these data, along with findings on the mechanism of action of CB...