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Kalytera Reports Data for First Cohort in Phase 2 Clinical Study Evaluating CBD in Prevention of Acute GVHD
Kalytera Reports Data for First Cohort in Phase 2 Clinical Study Evaluating CBD in Prevention of Acute GVHD.
About this update from Claritas Pharmaceuticals Inc.
[{"type":"text","content":"\nSAN FRANCISCO and TEL AVIV, Israel, March 22, 2019 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the \"Company\" or \"Kalytera\") today announced positive data from its ongoing Phase 2 clinical study evaluating cannabidiol (“CBD”) for the prevention of acute graft versus host disease (“GVHD”) following bone marrow transplant.\n The clinical study criteria that are used to determine the efficacy of CBD in prevention of acute GVHD are: Disease free survival at Day 100 after bone marrow transplant;Disease free survival at Day 180 after bone marrow transplant;Cumulative incidence of grade 2-4 acute GVHD at Day 100 after bone marrow transplant; andCumulative incidence of grade 2-4 acute GVHD at Day 180 after bone marrow transplant. To date, 3 of the 12 patients in the first cohort have died from causes unrelated to GVHD. The data for the remaining 9 patients demonstrate encouraging preliminary evidence of efficacy as measured by each of the above listed outcome endpoints: Disease free survival at Day 100: Eight of the 9 surviving patients are disease free (no evidence of grades 2-4 acute GVHD) at Day 100;Disease free survival at Day 180: Three patients are now more than 180 days post bone marrow transplant, and each of these patients is disease free;Cumulative incidence of grade 2-4 acute GVHD at Day 100: The cumulative incidence of grades 2-4 acute GVHD at Day 100 is encouraging, with only one patient having developed grade 2 acute GVHD, the least serious form of the disease, prior to Day 100; andCumulative incidence of grade 2-4 acute GVHD at Day 180: The cumulative incidence of grades 2-4 acute GVHD at Day 180 is encouraging, with only one patient having developed grade 2 acute GVHD, and with none of the surviving patients who are now more than 180 days post bone marrow transplant having developed grades 2-4 acute GVHD. In summary, no patients in the first cohort of the Phase 2 clinical study have developed grades 3 or 4 acute GVHD while receiving oral CBD treatment, and only one patient developed grade 2 acute GVHD. “We are very encouraged by these excellent results,” stated Robert Farrell, President and CEO of Kalytera. “The first cohort in our Phase 2 study is the low dose cohort, with patients receiving only 75 mg of CBD twice daily (̶...