TSXV:CLAS.H - Post by User
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Busyzzindahouseon Jun 26, 2018 7:29am
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Phase 2a results - tested and proven
Phase 2a results - tested and proven The results from the first of these Phase 2a clinical studies were published in Biology of Blood and Marrow Transplantation (Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study, M. Yeshurun et al. / Biol Blood Marrow Transplant 21 (2015) 1770 – 1775). The data from this study, in which 48 patients received daily doses of 150 mg of CBD administered twice daily for 7 days prior to the bone marrow transplant procedure and for 30 days after, demonstrated the following results:
- No patients developed acute GVHD while being treated with CBD;
- The rates of grades 2-4 acute GVHD by day 100 were 12.1%, compared with 46% in 101 historical control subjects who received standard GVHD prophylaxis at the same institution in Israel (the Institute of Hematology, Davidoff Center, Rabin Medical Center); and CBD was found to be safe and well tolerated.
In the second of the two prior Phase 2a clinical studies, 12 patients were administered CBD at a dose of 150 mg administered twice daily from 7 days prior to the bone marrow transplant procedure until up to 100-days post transplantation. In that study, no safety issues were observed, and only 15% of patients in the CBD treatment group developed grades 2-4 acute GVHD, compared to a 60-70% incidence predicted by historical data from patients treated at the same institution in Israel (the Institute of Hematology, Davidoff Center, Rabin Medical Center) that were used as a control.