SAN FRANCISCO & TEL AVIV, Israel--(BUSINESS WIRE)--Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the "Company" or "Kalytera") today announced that the U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 9,889,100 B2 with claims covering the use of cannabidiol ("CBD") for the treatment of severe and refractory graft versus host disease ("GVHD"). Kalytera has exclusive worldwide rights to this issued patent through an Exclusive License Agreement with MOR Research Applications, Ltd. of Israel (“Mor”).
GVHD is a multisystem disorder that 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, gastrointestinal tract, liver, lungs and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life and death.
In November 2017, Kalytera announced that it had received notice from the USPTO that the application for this patent would be allowed. The issuance of this patent by the USPTO is the final step in the patent application process, and provides patent coverage to Kalytera for the use of CBD in the treatment of GVHD through April 2034 under the Exclusive License Agreement with Mor.
CBD is a non-psychoactive cannabis compound that possesses therapeutic potential across a broad range of diseases and disorders, and is being evaluated by Kalytera and other companies for treatment of several diseases and disorders other than GVHD. Kalytera’s work with CBD in the treatment of GVHD is expected to be the first of several programs the Company will undertake to investigate and commercialize this important compound.
Kalytera’s ongoing Phase 2 clinical program evaluating the use of CBD in the prevention of GVHD is expected to be completed later this year, at which time Kalytera will begin preparations for the pivotal Phase 3 study that will be required for FDA approval. Kalytera also expects to initiate an additional Phase 2 clinical study in treatment of GVHD later this year.
“We are delighted by the issuance of this patent for CBD in the treatment of GVHD,” said Robert Farrell, President and CEO of Kalytera. “CBD is a remarkable compound that has shown activity against a number of pharmacological targets, and the safety of CBD has been demonstrated in several clinical studies. Importantly, later this year we expect to see another company receive the first ever approval of a CBD pharmaceutical product.”
Mr. Farrell went on to say that, “There are currently few options to treat persons with GVHD, a critically underserved market. The data from our previous clinical study evaluating CBD in the treatment of acute GVHD were exceptional and unprecedented. Ten patients with acute (Grade 3-4) GVHD who were refractory to standard treatment with high-dose steroids were administered daily doses of CBD for up to three months. Nine of the ten patients responded to treatment, with seven achieving complete remissions, and with two achieving near-complete responses. Based on these very positive data, we believe that our proprietary CBD therapeutic may provide a major advance in the treatment of this disease.”
The commercial opportunity for Kalytera’s CBD product in the treatment of GVHD is large. According to the January 2018 Market Forecast Report by DelveInsight Perspective, the potential size of the market for a successful product in the seven major jurisdictions (the U.S., Germany, France, Italy, Spain, the U.K. and Japan) is estimated to be more than USD $408 million in 2018, and could grow to approximately USD $1.3 billion by 2027.
Kalytera acquired its program in the prevention and treatment of GVHD in February 2017 through the acquisition of Talent Biotechs, Ltd. of Israel ("Talent"). Under its agreement with the former Talent shareholders, Kalytera is obligated to make additional contingent payments in cash and Kalytera common shares to the former Talent shareholders upon the achievement of certain milestones, including upon the issuance of the first patent by the USPTO. With the issuance of U.S. Patent No. 9,889,100 B2 by the USPTO, Kalytera is now obligated to make a payment to the former Talent shareholders of 2,883,535 common shares, and a cash payment of USD $2 million.
About Kalytera Therapeutics
Kalytera Therapeutics, Inc. ("Kalytera") is pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of novel cannabinoid medicines for a range of important unmet medical needs, with an initial focus on graft versus host disease and the treatment of acute and chronic pain.
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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 at all, or may produce unfavourable results, and the risk that applicable regulatory approvals may not be obtained in a timely manner or at all. 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.