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Kalytera Planning Clinical Trials for Cannabinoid GvHD Treatment

April 25, 2017


VANCOUVER, British Columbia, April 25, 2017 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSXV:KALY), a clinical-stage biopharmaceutical company developing next-generation cannabinoid-derived therapeutics, today announced that it has developed the multi-center location component of the plan for the proposed clinical trials to evaluate cannabidiol (“CBD”) for the prevention and treatment of Graft versus Host Disease (“GvHD”). Kalytera is developing this clinical trial plan with the intent of obtaining FDA and EMEA approval for commercialization.


Kalytera expects to finalize and publish the details of its clinical trial plan during the current quarter ending June 30, 2017. The plan will include the clinical trial designs, the anticipated timelines for initiation and completion, as well as the principal endpoints. The trials are intended to build on the encouraging data seen in the recently completed Phase 2a Clinical Trial.


In March 2017, Dr. Andrew L. Salzman, Kalytera’s Chief Executive Officer, and Dr. Sari Prutchi Sagiv, Kalytera’s Vice President of Scientific Operations, attended the 43rd Annual Meeting of the European Society for Blood and Marrow Transplantation (“EBMT”) in Marseilles, France. Prior to joining Kalytera, Dr. Sagiv led the CBD-GvHD clinical research program at Talent Biotechs (“Talent”); Talent was acquired by Kalytera in February 2017.


The EBMT Annual Meeting brings together thought leaders from Europe and the world to explore the latest allogenic hematopoietic stem cell transplantation (“HCT”) and cellular therapy research. Having met and conferred with many of the leading authorities at EBMT, Drs. Salzman and Sagiv have developed a multi-center site plan for Kalytera’s planned clinical trials.


“Kalytera’s recent groundbreaking clinical trial with CBD as a treatment for GvHD generated a great deal of excitement at EBMT,” said Dr. Salzman. “The EBMT annual meeting brings together the world’s leading authorities in HCT, a lifesaving procedure for a number of diseases. HCT patients will benefit tremendously if the risk of GvHD can be substantially reduced.


“Based on the encouraging results from our Phase 2a studies, we believe that CBD has the potential to help patients with GvHD who routinely fail first-line therapy with steroids. Kalytera intends to undertake additional clinical studies in an effort to obtain regulatory approval to use CBD for the treatment and prevention of GvHD. Under Dr. Sagiv’s direction, we are working to complete our next, major clinical trial plan. We look forward to publishing the details of that plan this quarter.”


About GvHD and Kalytera’s CBD Clinical Research Program

GvHD is an FDA and EMEA-designated “orphan disease.” GvHD is a major cause of morbidity and mortality after HCT. It is a multisystem disorder that occurs when the transplanted cells from a donor (“the graft”) recognize the transplant recipient (“the host”) as foreign. Typically, only 60% of patients respond to first-line therapy with high-dose steroids. The 12-month mortality rate among patients with steroid-refractory Grade 3 and 4 GvHD exceeds 60% and 80%, respectively. In February 2017, Kalytera published results of a Phase 2a Clinical Study evaluating the safety and efficacy of CBD for treating Acute GvHD, with promising initial results.


About Kalytera

Kalytera (TSXV:KALY) is a clinical-stage pharmaceutical company pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and growing 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 is also developing 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 CBD, including its poor oral bioavailability which greatly limits the efficacy of medical marijuana edible products that contain a high level of CBD. Kalytera is developing innovative CBD formulations and prodrugs intended for commercialization as FDA and EMEA-approved prescription medications in an effort to overcome these limitations, and to target specific disease sites within the body. Kalytera has filed composition of matter and method of use patents covering its novel inventions.


Forward-looking Statement Disclaimer

This news release may contain “forward-looking information” within the meaning of applicable securities laws. Although Kalytera believes in light of the experience of its officers and directors, current conditions and expected future developments and other factors that have been considered appropriate, that the expectations reflected in this forward-looking information are reasonable, undue reliance should not be placed on them because Kalytera can give no assurance that they will prove to be correct. 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. The statements in this press release are made as of the date of this release. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third-parties in respect of Kalytera, its securities, or its respective financial or operating results (as applicable). Kalytera disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

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