SAN FRANCISCO and TEL AVIV, Israel, Dec. 05, 2017 (GLOBE NEWSWIRE) -- 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.
About Kalytera Therapeutics
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.
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 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.
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