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Kalytera Announces Submission of Patent Application to the U.S. Patent and Trademark Office

Claims Cover Treatment of Ulcerative Colitis, Crohn’s Disease, Inflammatory Bowel Disease, GVHD and other Inflammatory Diseases of the GI Tract

SAN FRANCISCO and TEL AVIV, ISRAEL, May 29, 2019 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF) (the "Company" or "Kalytera") today announced that it has filed a provisional patent application with the United States Patent and Trademark Office (“USPTO”) covering Kalytera’s novel compositions of cannabidiol (“CBD”) in combination with certain metabolites of the human microbiome as a potential treatment for ulcerative colitis, Crohn’s disease, inflammatory bowel disease (“IBD”), graft versus host disease (“GVHD”) and other GI tract inflammatory diseases.

The patent application is based on recent novel findings from laboratory research conducted by Kalytera, including key findings demonstrating that CBD and certain metabolites of the human microbiome, when administered in combination, have an unexpected and superior effect upon improvement of gastrointestinal epithelial barrier function than does either such component administered separately. 

Patent Claims Include:

  1. The pharmaceutical composition of CBD and a bacterial metabolite of tryptophan or butyric acid, as a highly effective treatment for gastrointestinal diseases or disorders characterized by damage to the gastrointestinal epithelial tight junctions and consequent abnormal intestinal permeability.
  2. The use of such pharmaceutical composition for improving gastrointestinal epithelial barrier function.
  3. The use of such pharmaceutical composition for treatment of ulcerative colitis, Crohn’s disease, IBD, acute or chronic GVHD, or any other acute or chronic gastro-intestinal inflammation.

Kalytera’s Research
Kalytera operates a research laboratory focused on understanding and identifying the activity of CBD and other cannabinoids in combination with metabolites produced by the human microbiome. 

The Significance of Kalytera’s Findings
Breakdown of the epithelial cell barrier lining the GI tract can lead to IBD and other intestinal diseases. In the most serious cases, bacteria are able to pass through the non-functioning barrier and enter the bloodstream, causing sepsis, a potentially life-threatening condition.

Kalytera’s work has confirmed that CBD alone promotes direct repair of the damaged epithelial cell barrier. Kalytera’s work has further shown that this repair can be substantially amplified by combining administration of CBD with administration of certain metabolites produced by the human microbiome.  Specifically, the metabolites that were found to act synergistically with CBD are sodium butyrate, indole, indoxyl, indoxyl sulfate and indoxyl phosphate (the “Microbiome Metabolites”).

Kalytera’s research data demonstrate for the first time that CBD exhibits pharmacologic activity through a nuclear protein called the aryl hydrocarbon receptor, or AhR. AhR activation is known to improve intestinal epithelial barrier function by maintaining the integrity of tight junctions. CBD alone was shown to have a dramatic effect on the AhR signaling pathway, resulting in a 23-fold increase in activation of this pathway. However, when CBD was combined with one or more of the Microbiome Metabolites, this activity was amplified. For example, a combination of CBD and indole resulted in a 50-fold increase in AhR activation after only 8 hours of treatment. Furthermore, a combination of CBD and one or more of the Microbiome Metabolites completely blocked epithelial leakage, as measured by the electrical resistance of the epithelial barrier. This large effect underscores the significant role that CBD and these Microbiome Metabolites may play in repair of epithelial barrier damage.

“Our work to understand and elucidate the mechanism of action of CBD in the prevention and treatment of GVHD has led to our discovery that CBD administered together with certain bacterial metabolites is a potentially highly effective treatment for gastrointestinal diseases or disorders characterized by damage to the tight junction epithelial cell lining of the GI tract,” stated Robert Farrell, Kalytera’s President and CEO.“We have filed a provisional patent covering this important discovery, and we intend to capitalize on this discovery through initiation of new product development programs in the treatment of inflammatory bowel diseases and other intestinal diseases.”

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 and treatment of acute and chronic pain.

Cautionary Statements
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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