Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera“) today announced that it met with the United States Food & Drug Administration (“FDA”) for a pre-Investigational New Drug (“pre-IND”) meeting regarding the Company’s program evaluating cannabidiol (“CBD“) in the treatment of acute graft versus host disease (“GVHD“).
Commenting on the meeting, Robert Farrell, President and CEO of Kalytera, said, “We recently submitted questions to the FDA as part of our pre-IND submission package. During the meeting, the FDA responded verbally to our questions, and will provide formal written guidance within 30-days.”
During the meeting, the FDA asked that the Company assess certain safety and laboratory parameters of CBD, including the effect of food intake on the absorption of oral CBD and the interaction of CBD with certain anti-fungal drugs that are frequently prescribed for patients with severe acute GVHD. In order to make these assessments, the Company plans to initiate two clinical studies in healthy volunteers this year. These studies will be conducted in parallel with a 45-patient, blinded, randomized, placebo-controlled study in patients with grades 3-4 acute GVHD, that the Company plans begin by Q4 this year, with a target completion date of mid-2019.
Kalytera’s program evaluating CBD for the treatment of acute GVHD is designed to meet a clear unmet medical need. 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 Therapeutics, Inc. is pioneering the development of CBD therapeutics for life-threatening unmet medical needs. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines and proprietary cannabinoid therapeutics for a range of important unmet medical needs, with an initial focus on GVHD and 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 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.