Kalytera Announces Notice of Allowance of US Patent for Treatment of Graft Versus Host Disease
Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the "Company" or "Kalytera") is pleased to
announce that the United States Patent and Trademark Office has issued a Notice of Allowance for US Patent Application 15/143,694
covering the use of cannabidiol ("CBD") in the treatment of graft versus host disease ("GVHD"). Securing a patent for
this proprietary technology represents an important step forward for the Company in its work focused on the treatment of this
serious and life-threatening disease.
"We are delighted to receive this Notice of Allowance from the USPTO", said Robert Farrell, J.D., Kalytera's Chief Executive
Officer. "There are currently few options to treat persons with GVHD, a critically underserved market. The results of the previous
four clinical studies that evaluated CBD in the prevention and treatment of GVHD were exceptional and unprecedented. Based on that
data, we believe that our proprietary CBD based therapeutic may provide a major advance in the prevention and treatment of this
disease, and we anticipate that we will also soon receive Notice of Allowance for our US Patent Application 14/787,515 that covers
both the use of CBD in the prevention of graft versus host disease, and the treatment of graft versus host disease.” Kalytera has
exclusive world-wide rights to the technology that is covered by both of these patents.
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
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 of failure to obtain a Notice of Allowance for our other US Patent Application
14/787,515 and 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.
Kalytera Therapeutics, Inc.
Robert Farrell, 888-861-2008
President, CEO
info@kalytera.co
View source version on businesswire.com: http://www.businesswire.com/news/home/20171115005399/en/