This morning, Kalytera Therapeutics Inc. (TSXV:KALY)(OTC:KALTF) announced that the company has submitted an application to to the institutional review boards of two clinical sites in Israel for a planned phase two clinical trial evaluating cannabidiol (CBD) for the prevention of Graft versus Host Disease, a.k.a. GvHD.
Graft versus Host Disease (GvHD) is a common, life threatening complication of transplants, especially blood and bone marrow transplants. Graft versus Host Disease occurs when the white blood cells in the donated tissue (the graft) recognize the recipient (the host) as foreign causing them to attack the hosts body cells. Current treatments for GvHD include drugs that reduce your body’s immune response including statins, steroids and select biologics. CBD possesses both anti-inflammatory and immunosuppressive properties and appears to lack some of the problems associated with current treatments including the increased risk of infection and cancer relapse. A previous phase two study found that CBD shows significant potential for the prevention of GvHD when used in combination with the standard GvHD prophylaxis (prevention protocol).
The proposed study is an open label (meaning both the researchers and the subjects will know the treatment that is being administered), multicenter trial (the study will be conducted at the Rabin Medical Center and the Rambam Health Care Campus in Israel) to test the safety, efficacy and pharmacokinetic profile of varying doses of CBD for the prevention of GvHD following allogeneic hematopoietic cell transplantation. Allogeneic hematopoietic cell transplantation is the intravenous infusion of allogeneic (genetically different) stem cells to help reestablish the production of white and red blood cells in patients whose bone marrow or immune system is affected by disease (usually cancer).
Upon receipt of institutional review board approval (expected this quarter), Kalytera intends to initiate the phase 2 study as quickly as possible.
In midday trading on the day of this announcement, shares of Kalytera Therapeutics are trading higher by more than 9% on the TSX Venture. The company's OTC Markets listing is rising more than 6% on lighter than average volume.
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