Kalytera Therapeutics, Inc. (TSX-V:KALY) and (OTCQB:KALTF) (the “Company” or “Kalytera”) today announced the initiation of a Phase 2 clinical study evaluating the use of cannabidiol (“CBD”) in the prevention of graft versus host disease (“GVHD”). Kalytera also announced today that it has entered into an agreement with The Salzman Group of Israel, under which The Salzman Group will, among other things, accept common shares of Kalytera in payment for its services in connection with the Phase 2 study, subject to TSX Venture Exchange approval.
Initiation of Phase 2 Clinical Study in Prevention of Graft Versus Host Disease
The Phase 2 study is designed to assess the pharmacokinetic and safety profile of multiple doses of CBD for the prevention of GVHD. The study is expected to enroll 36 patients following allogeneic hematopoietic cell transplantation, and will take place at Beilinson Hospital, and one other major medical center in Israel. Results of the study are expected by Q3 2018.
The Company anticipates that, following completion of the Phase 2 study, it will initiate the Phase 3 study as quickly as possible.
“We are focused on advancing this program from its current Phase 2 status to Phase 3 status as quickly and efficiently as possible, and the initiation of this Phase 2 study is an important and essential step in that process,” said Robert Farrell, President and CEO of Kalytera.
The Principal Investigator of the study is Daniel Couriel, M.D., M.S., Director of the Bone Marrow Transplant Program at the University of Utah Health Sciences, School of Medicine.
Other experts in the field of GVHD who will advise the Company with regard to the study include Edmund Waller, M.D., PhD., Professor, Hematology and Medical Oncology, Medicine, and Pathology at Emory University School of Medicine, and Director, Division of Stem Cell Transplantation and Immunotherapy at Winship Cancer Institute of Emory University; and Rafael Duarte, M.D., Ph.D., Director of the Haematopoietic Transplant Programme at the Catalan Oncology Institute in Barcelona.
Agreement with The Salzman Group
Kalytera also announced today that it has entered into an agreement with The Salzman Group (the “Agreement”), under which The Salzman Group will provide clinical study management services in relation to the Phase 2 study, including chemistry, manufacturing and controls (“CMC”) analytics, as well as stability studies, toxicology studies and drug-drug interaction studies, all of which will be required by the FDA to be completed prior to initiation of a Phase 3 pivotal study. The estimated cost of these services is expected to be approximately $1,240,000 over an 11-month period, and Salzman Group has agreed that it will accept payment in common shares of Kalytera for these services, subject to TSX Venture Exchange approval.
“We are pleased to establish this important funding and clinical studies management agreement with The Salzman Group,” said Robert Farrell, President and CEO of Kalytera. “The Salzman Group is an international pharmaceutical development firm with a strong track record and over two decades of comprehensive experience in drug development, including drug design, process scale-up, formulation, efficacy modeling and design and management of clinical studies. This agreement with The Salzman Group will enable Kalytera to advance our Phase 2 program in the prevention of GVHD, and position us to begin Phase 3 clinical testing during the second-half of next year.”
The Salzman Group will invoice Kalytera for this work in fixed amounts, on a monthly basis as specified in the Agreement, and Kalytera will have the option to make payments in either cash or common shares of the Company (“Common Shares”), in accordance with applicable securities laws and TSX Venture Exchange policies. If Kalytera chooses to pay any such invoice through the issuance of Common Shares, the number of shares of Common Shares that will be issued will be based on a ten percent (10%) discount from the closing price of Kalytera’s Common Shares on the TSX Venture Exchange on the trading day prior to the day that Kalytera gives notice to the Salzman Group that it intends to pay the invoice in Common Shares. The Salzman Group will establish an irrevocable selling agreement with its broker to sell such shares on each of the three trading days following deposit of such shares in its brokerage account.
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 versatile 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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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 and the risk that the TSX Venture Exchange may not approve the shares for services arrangement on the terms described or at all. 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.