Kalytera submits Phase II study protocol to IRBs for cannabidiol in the prevention of GvHD

The Phase II study is designed to generate the pharmacokinetic and safety data, at multiple dose levels, that will be required by the FDA.

The proposed study is a Phase II, open label, multicenter trial to evaluate the pharmacokinetic profile, safety, and efficacy of multiple doses of CBD for the prevention of GvHD following allogeneic hematopoietic cell transplantation (HCT). The proposed study will take place at the Rabin Medical Center, Beilinson, and the Rambam Health Care Campus, Haifa, in Israel.

“This study is the next step in our development program designed to obtain FDA approval of CBD in the prevention of GvHD,” said Robert Farrell, President and Interim CEO of Kalytera. “The Phase II study is designed to generate the pharmacokinetic and safety data, at multiple dose levels, that will be required by the FDA as we move towards a pivotal Phase III clinical study. We anticipate that Kalytera will receive approval from both IRBs this quarter, after which we plan to initiate the Phase II study as quickly as possible.”

GvHD is a multisystem disorder that is a common, life-threatening complication of hematopoietic stem cell transplant procedures. GvHD occurs when the transplanted donor cells attack the patient’s organs, including the skin, gastrointestinal tract, liver, lungs, and eyes. GvHD is associated with acute and chronic illness, infections, disability, reduced quality of life, and death.