Kalytera Therapeutics has concluded the second phase of a study examining the possibility of using CBD as a treatment for Graft versus Host Disease. It has been shown that CBD may significantly reduce the chance of developing the condition.
Graft versus Host Disease (GvHD) is a condition that is often developed by patients who have received a blood marrow or stem cell transplant. The disease occurs when white blood cells from the donated bone marrow or stem cells (the graft) begin to attack the patient’s own (the host’s) cells.
The symptoms of acute GvHD can include rashes on the skin, jaundice, and problems with the liver and digestive system. However, chronic GvHD can be fatal. Patients are at higher risk of contracting the disease when the donor is not related to them.
Kalytera has assessed the results for the second phase of their clinical trial. The study followed 48 transplant patients for 16 months following the procedure. The results showed that only (8%) patients receiving a low dose of CBD developed grade 2-4 acute GvHD. The historic norm for patients developing grade 2-4 acute GvHD is 60%-70%.
“We did not expect the results from the low dose cohort to be as positive as they were. Now we have interim results from the medium dose cohort that are equally as good.”
The results were even more positive in patients given a medium dose of CBD, with no patients developing the disease. Due to the positive results, the Company has decided to forego further Phase 2 study.
Robert Farrell, President, and CEO of Kalytera said:
“We believe the data to date in our Phase 2 study exceed what will be required in a Phase 3 registration study to demonstrate the efficacy of CDB in prevention of acute GVHD, and leave little or no room for improvement with the high dose. For this reason, we have decided to halt the ongoing Phase 2 clinical study without enrolling the high dose cohort. [We will] proceed directly to initiate a Phase 3 clinical registration study.”
Phase 3 of the study will be a double-blind placebo-controlled clinical trial. In the trial, 50 patients will be given either a 150mg dose of CBD or placebo, twice daily. Patients will be carried out across clinical sites in Australia and Israel, and the duration will be approximately 12 months.