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Kalytera Provides Update on its Lead Program in Prevention and Treatment of GVHD
Kalytera Provides Update on its Lead Program in Prevention and Treatment of GVHD.
About this update from Claritas Pharmaceuticals Inc.
[{"type":"text","content":"\nSAN FRANCISCO and TEL AVIV, Israel, June 21, 2018 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX-V:KALY) and (OTCQB:KALTF) (the \"Company\" or \"Kalytera\") today provided an update on its lead clinical 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 fully matched 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. The commercial opportunity for Kalytera’s CBD products for the prevention and treatment of GVHD is large. According to the January 2018 Market Forecast Report by DelveInsight Perspective, projected annual sales for prevention and treatment of GVHD in the 7 major markets  (the U.S., Germany, France, Italy, Spain, the U.K. and Japan) are estimated to be more than USD $408 million in 2018, and could grow to approximately USD $1.3 billion by 2027. Kalytera is the exclusive licensee of two issued U.S. patents covering the use of CBD in the prevention and treatment of GVHD, and is also the exclusive licensee of pending patent applications in other jurisdictions for the use of CBD in the prevention and treatment of GVHD. The U.S. FDA has recommended that Kalytera apply for both Breakthrough Therapy and Fast Track Designations for our CBD products for prevention and treatment of acute GVHD, each of which could accelerate the approval process for these products. CBD is a non-psychotropic ingredient of cannabis sativa that possesses potent immunomodulatory and anti-inflammatory properties. Kalytera’s Program Evaluating CBD in Prevention of Acute GVHD Our ongoing Phase 2b clinical study evaluating the use of CBD in the prevention of GVHD is expected to be completed early next year. We have enro...