Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced that the United States Patent and Trademark Office (the “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.
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.
Kalytera Therapeutics, Inc. is pioneering the development of CBD therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for important unmet medical needs, with an initial focus on GVHD.
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This press release may contain certain forward-looking information and statements (“forward-looking information”) within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives and other statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavourable results. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera’s control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.