Kalytera Therapeutics, Inc. (TSX VENTURE:KALY) (OTCQB:KALTF) (the “Company” or “Kalytera”) today announced that it will meet with the Center for Drug Evaluation and Research (“CDER”) of the U.S. Food and Drug Administration (“FDA”) on Tuesday, July 31, 2018. The meeting is to discuss numerous aspects of Kalytera’s planned registration study evaluating cannabidiol (“CBD”) for the treatment of acute graft versus host disease (“GVHD”).
Kalytera’s President and CEO, Robert Farrell, commenting on the meeting said, “The meeting with CDER is an important next step in the advancement of our program in treatment of acute GVHD. We recently submitted questions to the FDA as part of our pre-IND submission package. With answers to these questions and any additional information provided by CDER during the meeting, we will be in position to address any open issues or requests of CDER before submitting our IND. Once the IND is submitted and found to be acceptable to the FDA, we will initiate our planned registration study in treatment of acute GVHD.”
Kalytera’s program is designed to meet a clear unmet medical need in patients with acute GVHD. 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. There is currently no FDA approved therapy for the treatment of acute GVHD.
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.