Press Release

Kalytera to Announce Phase 2a Clinical Study Results Investigating CBD for the Treatment of Acute Graft versus Host Disease

By February 16, 2017 December 20th, 2018 No Comments
Kalytera to host conference call and webcast on Thursday, February 23, 2017 at 12:00 PM ET

Kalytera Therapeutics, Inc. (TSXV: KALY) (“Kalytera”) will announce the results of a Phase 2a study investigating the safety and efficacy of cannabidiol (“CBD”) for the treatment of acute (Grades 3-4) Graft versus Host Disease (“GvHD”) on Wednesday, February 22, 2017. A conference call and webcast will be held on Thursday, February 23, 2017 at 12:00 PM ET to discuss the study results.

The Phase 2a study was conducted by Talent Biotechs, Ltd. (“Talent”), an Israeli-based company evaluating the use of CBD to prevent and treat GvHD, that has been newly acquired by Kalytera.

GvHD is a multisystem disorder that is a common, life-threatening complication of hematopoietic stem cell transplant (“HCT”) procedures. HCT is a lifesaving procedure for many diseases of the blood and bone marrow including leukemia, Hodgkin and Non-Hodgkin lymphoma, and multiple myeloma. 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.

The Phase 2a treatment study enrolled ten patients with acute GvHD, including five patients with Grade 3 GvHD and five patients with Grade 4 GvHD. All ten patients were steroid refractory, meaning that they had not responded to previously administered standard of care steroid treatment. Patients were administered daily doses of CBD for up to three months, alongside standard of care therapy.

Conference Call and Webcast Information

The conference call and webcast will be available for replay on the Kalytera website.

About Kalytera Therapeutics

Kalytera (TSXV:KALY) 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.

Kalytera is focused first on 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 natural CBD, including its poor oral bioavailability and short half-life. Kalytera is developing 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.

Kalytera Company Contact

Robert Farrell
President, COO and CFO
Phone: (888) 861-2008

Cautionary Note

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) has in any way passed upon the merits of the proposed Transaction and associated transactions and neither of the foregoing entities has in any way approved or disapproved of the contents of this press release.

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.

Forward-Looking Statement Disclosure

This news release contains “forward-looking information” within the meaning of applicable securities laws, including information relating to the Phase 2a clinical trial. 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 depending on, among other things, the risks of failure of the results of the Phase 2a clinical trial to be consistent with the preliminary results of such trial, that the Phase 2a clinical trial results are not determinative of or consistent with the results of the results of future Phase 2 or other clinical studies, that the small number of patients in the Phase 2a clinical trial may contribute to the risk that future studies may be inconsistent with the results of the Phase 2a clinical trial, and that clinical trials are subject to a number of other health, safety, efficacy and regulatory risks. 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, Talent, their securities, or their 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.