Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office for a second patent covering the use of cannabidiol (“CBD”) in the prevention and treatment of graft versus host disease (“GVHD”).
“We are delighted to receive this additional patent allowance from the USPTO”, said Robert Farrell, Kalytera’s Chief Executive Officer. “This allowance is for our US Patent Application 14/787,515. Two weeks ago, we announced that we had received a Notice of Allowance for our US Patent Application 15/143,694. We now have two allowed US patents, which together cover both the prevention and treatment of GVHD. Kalytera has exclusive world-wide rights to the technology covered by both of these patents.”
Mr. Farrell continued, “We are now positioned to move forward with our program to obtain FDA approval of CBD in the prevention of GVHD. The next step in this process will be the initiation of a Phase 2 clinical study designed to assess the pharmacokinetic and safety profiles of multiple doses of CBD, and we anticipate that this study will begin prior to year-end.”
Kalytera’s Phase 2 study is expected to enroll 36 patients following allogeneic hematopoietic cell transplantation (“HCT”), commonly referred to as bone marrow transplantation. The study will take place at the Rabin Medical Center, Beilinson, and Rambam Health Care Campus, Haifa, in Israel. Completion of this study will take approximately eight months, and is required by the FDA prior to the initiation of a pivotal Phase 3 study. Results of the study are expected by Q3 2018. Following completion of the Phase 2 study, the Company will initiate the Phase 3 study as quickly as possible.
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.
There are currently few options available to treat persons with GVHD, a critically underserved market. The results of four previous clinical studies that evaluated CBD in the prevention and treatment of GVHD were exceptional and unprecedented. Based on that data, the Company believes that its proprietary CBD based therapeutic may provide a major advance in the prevention and treatment of this disease.
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 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.