Kalytera Announces Data Further Elucidating CBD’s Mechanisms of Action in Prevention of GVHD

New Research Demonstrates Activity of CBD in Repair of Damaged Epithelial Cells

| Source: Kalytera Therapeutics Inc. Kalytera Therapeutics Inc.

SAN FRANCISCO and TEL AVIV, Israel, May 28, 2019 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF) (the "Company" or "Kalytera") today announced new laboratory findings demonstrating that cannabidiol (“CBD”) acts through a distinct biological pathway to restore epithelial cell tight junction integrity, which is highly important in preventing acute graft versus host disease (“GVHD”) and associated comorbidities.

Acute GVHD is a life-threatening complication commonly occurring after bone marrow transplant procedures.

Prior to the bone marrow transplant, patients typically undergo a total body irradiation (“TBI”) procedure. The TBI procedure damages the patient’s epithelial cells, including those that line the GI tract. This damage breaks down the tight junction barrier that healthy epithelial cells provide. This loss of barrier integrity predisposes the patient to infection and overwhelming sepsis (blood poisoning) as bacteria from the gut microbiome pass through the damaged epithelial cell barrier and enter the patient’s bloodstream. Damage to the epithelial cell lining of the GI tract is a serious and life-threatening comorbidity of acute GVHD, and sepsis is the main cause of death in patients with severe acute GVHD.

Following the bone marrow transplant, patients are at significant risk of developing acute GVHD. Acute GVHD is an immune disorder that occurs when immune cells from the bone marrow donor (known as the graft) attack or reject the organs and tissues of the patient (the host). It is estimated that up to 50% of patients who undergo a bone marrow transplant from a sibling donor, and up to 70% of patients who undergo a bone marrow transplant from an unrelated donor, will develop some level of GVHD. There are currently no FDA approved therapies for either the prevention or treatment of acute GVHD.

“An ideal preventive therapy for acute GVHD would act to both repair the damage to epithelial cells caused by the TBI procedure, and act as an immunosuppressant to suppress the attack by the donor’s immune cells against the patient’s organs and tissues. It is already well established that CBD acts as an immunosuppressant, and now our research confirms that CBD also acts through a distinct biological pathway to repair the damage to epithelial cells caused by the TBI procedure,” stated Robert Farrell, Kalytera’s President and CEO. “Our laboratory findings, as well as research done by others, demonstrate that CBD has a dual mechanism of action that might be ideal for prevention of acute GVHD.”

Significance of Kalytera’s Preclinical Findings
Epithelial cell damage from TBI is a serious and life-threatening comorbidity of acute GVHD. It is essential that the epithelial cell tight junction function and barrier integrity in the GI tract be restored in order to mitigate the risk of bacteria entering the patient’s bloodstream, which may result in sepsis and risk of death.

Kalytera’s research data confirm that CBD promotes repair of the leaky epithelial barrier lining the GI tract.

Results from Kalytera’s research demonstrate that CBD repaired epithelial tight junctions in a cell culture model of acute gut inflammation. Kalytera used this model to 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. The Company’s data demonstrate that CBD has a dramatic effect on the AhR signaling pathway, resulting in a 23-fold increase in activation of this pathway in the cell culture model used in this research. These data underscore the significant role that CBD may play in repair of epithelial barrier damage.

“We are excited about these new data which demonstrate CBD’s unique mechanism of action for repair of the epithelial cell tight junction function, thereby reducing the risk of bacterial infection and sepsis,” stated Farrell. “Our findings shed light on CBD’s mode of action in the GI tract. The fact that CBD can dramatically activate AhR signaling in epithelial cells also opens a new avenue of research that will lead us to more effective GVHD treatment.”

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. 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.

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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