Business
Kalytera Therapeutics Provides Update for Lead Program in Prevention and Treatment of GVHD
Kalytera Therapeutics Provides Update for Lead Program in Prevention and Treatment of GVHD.
About this update from Claritas Pharmaceuticals Inc.
[{"type":"text","content":"\nSAN FRANCISCO and TEL AVIV, Israel, Sept. 20, 2018 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the \"Company\" or \"Kalytera\") today provided an update on its lead product development program evaluating cannabidiol (“CBD”) for the prevention and treatment of acute graft versus host disease (“GVHD”).\n GVHD is a life-threatening complication commonly occurring after bone marrow transplant procedures. GVHD occurs when the transplanted donor cells attack the patient’s organs, including the skin, GI tract, liver, lungs, and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life, and death. It is estimated that up to 50% of patients who undergo a bone marrow transplant from a sibling donor, and up to 70% of patients who undergo a bone marrow transplant from an unrelated donor, will develop some level of GVHD. There are currently no FDA approved therapies for either the prevention or treatment of acute GVHD. CBD is a non-psychotropic ingredient of cannabis that does not cause euphoria or cognitive effects. The formulation of CBD that Kalytera is evaluating for the prevention and treatment of acute GVHD is a proprietary formulation that is designed to improve product stability and absorption after oral dosing.  Kalytera’s Two Separate Programs in GVHD The work that Kalytera is doing in GVHD consists of two separate product development programs: a program evaluating CBD for the prevention of acute GVHD; and a separate program evaluating CBD for the treatment of acute GVHD. Although there is some overlap between the two programs in terms of the data that will be required for FDA registration and marketing approval, the Phase 2 and Phase 3 clinical studies for each of these two programs will be separate and distinct. The Company’s program in prevention of acute GVHD is more advanced than is the program in treatment of acute GVHD. The prevention program is currently in Phase 2 clinical testing, with an ongoing study enrolling patients at three clinical sites in Israel. To expedite the enrollment process, Kalytera is expanding this study to include one additional site in Israel, and up to four additional sites in other jurisdictions, including Australia. Upon completion of this Phase 2 clinical study,...