At the request of IIROC, Kalytera Therapeutics, Inc. (TSX-V:KALY) (OTCQB:KALTF) (the “Company” or “Kalytera“) wishes to confirm that the Company’s management is unaware of any material change in the Company’s operations that would account for the recent increase in market activity.
As previously announced, as part of its program to obtain FDA approval of CBD in the prevention of GVHD, Kalytera anticipates that it will initiate a Phase 2 clinical study designed to assess the pharmacokinetic and safety profiles of multiple doses of CBD prior to year-end.
GVHD is a multisystem disorder that is a common, life-threatening complication of hematopoietic stem cell 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.
Kalytera is currently advancing its Phase 2 clinical program evaluating the use of CBD in the prevention of GVHD. Completion of this Phase 2 program will take approximately eight months, and is required by the FDA prior to the initiation of a pivotal Phase 3 study. The Phase 2 program includes an open label, multicenter trial to evaluate the pharmacokinetic and safety profiles of multiple doses of CBD for the prevention of GVHD following allogeneic hematopoietic cell transplantation (“HCT“). The Phase 2 clinical study will take place at the Rabin Medical Center, Beilinson, and Rambam Health Care Campus, Haifa, in Israel. The Company anticipates that, following completion of the Phase 2 study, it will initiate the Phase 3 study as quickly as possible.
CBD is a non-psychoactive cannabis compound that possesses remarkable therapeutic potential across a broad range of diseases and disorders. Kalytera’s work in GVHD is expected to be the first of several programs the Company will undertake that will seek to investigate and commercialize this important compound.
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 (“GVHD”) .
Kalytera also intends to develop a new class of proprietary cannabidiol (“CBD“) therapeutics. CBD is a remarkable compound that has shown activity against a number of pharmacological targets. However, there are limitations associated with natural CBD, including its poor oral bioavailability. Kalytera will seek to develop innovative CBD formulations and prodrugs in an effort to overcome these limitations, and to target specific disease sites within the body. Kalytera intends to file composition of matter and method of use patents covering its novel inventions, with the goal of limiting future competition.
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 are expressly qualified by this cautionary statement and are 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.