Kalytera Therapeutics announced the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for US Patent Application 15/905/050 covering the use of cannabidiol (CBD) in the prevention and treatment of graft versus host disease (GVHD).
“We are delighted to receive this Notice of Allowance from the USPTO,” said Robert Farrell, Kalytera’s President and CEO. “In addition to this new U.S. patent, we anticipate that our EU patent application covering the use of CBD in the prevention and treatment of GVHD will be granted later this month.”
Kalytera has exclusive worldwide rights to the use of CBD in the prevention and treatment of GVHD under two U.S. patents that were issued in 2018, as well as this new U.S. patent and the EU patent that is expected to be granted later this month. Kalytera has also obtained four orphan drug designations for the treatment and prevention of GVHD in the U.S. and Europe. In addition to protection from competition granted to the Company under its patents, the U.S. and EU orphan drug designations will provide 7 years of market exclusivity in the U.S., and 10 years of market exclusivity in the E.U., upon regulatory approval of the Company’s CBD products for the prevention and/or treatment of GVHD.
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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 approximately 50% of patients who undergo a bone marrow transplant will develop some level of GVHD. There are currently few options for the prevention and treatment of GVHD, a critically underserved market.
Based on the excellent data observed to date in the Company’s clinical studies, the Company believes that CBD has potential to become the first pharmaceutical treatment approved for prevention of acute GVHD following bone marrow transplantation, which would give the Company first mover advantage in this commercial space.