SAN FRANCISCO and TEL AVIV, Israel, Nov. 22, 2019 (GLOBE NEWSWIRE) — Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced that research reported in two peer-reviewed articles published in Blood provide further evidence supporting the activity of cannabidiol (“CBD”) in prevention and treatment of acute graft versus host disease (“GVHD”) and associated comorbidities. Blood is a peer-reviewed medical journal published by the American Society of Hematology.
Acute GVHD is a life-threatening complication commonly occurring after bone marrow transplant procedures.
An article published this month in Blood reported the case of a 35 year old patient who developed a variant of skin GVHD that is considered to be particularly aggressive, difficult to control, and which carries a poor prognosis. This patient was treated with a cannabinoid solution comparable to a 300-mg. dose of Kalytera’s product. As reported in the article, there was a definite response within 3 months, allowing discontinuation of other treatments, and by 2-years post bone marrow transplant, the patient’s skin issues had resolved with only mild itching and flakiness. (A Case Report of the Benefit of Cannabidiol (Cannabidiol (CBD)-Predominant Medical Cannabis Preparation) in the Management of Refractory Skin Graft Versus Host Disease (GVHD), Tsiporah B. Shore, MD, Jess B. Ryan, ANP, Michael B. Samuel, MD, November 13, 2019, Blood, Volume 134, Issue Supplement_1).
A second article published this month in Blood reported results of research with well-defined murine models of GVHD that examined the role of endocannabinoid signaling through the type 2 cannabinoid receptor (“CB2R”), which is expressed on all immune cells and natural ligands for this receptor. (Recipient Signaling through the Cannabinoid Type 2 Receptor Regulates IL-6 Independent Neuroinflammation during Graft Versus Host Disease, Alison Moe, PhD, Garrett Sauber, BS, Vivian Zhou, PhD, Anissa Lapitz, BS, Cecilia Hillard, PhD, William R. Drobyski, MD, November 13, 2019, Blood, Volume 134, Issue Supplement_1).
“Our laboratory findings, as well as the research reported in these peer-reviewed articles, point to the potentially important role of CBD in the prevention and treatment of GVHD,” stated Robert Farrell, Kalytera’s President and CEO.
CBD is a non-psychotropic ingredient of cannabis that does not cause euphoria or cognitive effects. The formulation of CBD that Kalytera is evaluating for the prevention and treatment of acute GVHD is a proprietary formulation that is designed to improve product stability and absorption after oral dosing.
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, including a EU patent application. The European Patent Office has issued a Notice of Allowance for the EU patent application, and the patent is expected to issue early next quarter. In addition to these patents and patent applications, the Company has also obtained four orphan drug designations for the treatment and prevention of GVHD in the U.S. and Europe. Such 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 acute 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.
Kalytera is continuing discussions with potential corporate partners for its GVHD program, as it begins planning and preparation for Phase 3 clinical testing of its CBD product in prevention of acute GVHD.
About Kalytera Therapeutics
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 a range of important unmet medical needs, with an initial focus on GVHD.
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.
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