Kalytera Therapeutics begins phase 2 clinical study
Kalytera Therapeutics Inc. has begun its phase 2 clinical study evaluating the use of cannabidiol in the prevention of graft versus host disease. The company has hired The Salzman Group of Israel for clinical study management services.
KALYTERA THERAPEUTICS Inc. has initiated a phase 2 clinical study evaluating the use of cannabidiol (CBD) in the prevention of graft versus host disease (GVHD). Kalytera has also 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 centre 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 chief executive officer of Kalytera.
The principal investigator of the study is Dr. Daniel Couriel, MD, MS, 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 Dr. Edmund Waller, MD, 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 Dr. Rafael Duarte, MD, PhD, director of the hematopoietic transplant program at the Catalan Oncology Institute in Barcelona.
Agreement with The Salzman Group
Kalytera has also entered into an agreement with The Salzman Group, under which The Salzman Group will provide clinical study management services in relation to the phase 2 study, including chemistry, manufacturin g and controls (C&MC) analytics as well as stability studies, toxicology studies and drug-drug interaction studies, all of which will be required by the U.S. Food and Drug Administration to be completed prior to initiation of a phase 3 pivotal study. The estimated cost of these services is expected to be approximately $1.24-million over an 11-month period, and The Salzman Group has agreed that it will accept payment in common shares of Kalytera for these services, subject to TSX-V approval.
“We are pleased to establish this important funding and clinical studies management agreement with The Salzman Group,” said Robert Farrell, president and chief executive officer 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 modelling, 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 ba sis, as spec ified in the agreement, and Kalytera will have the option to make payments in either cash or common shares of the company, in accordance with applicable securities laws and TSX-V 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 10-per-cent discount from the closing price of Kalytera’s common shares on the TSX-V 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.
About Kalytera Therapeutics Inc.
Kalytera Therapeutics 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.
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Ronald Peter Erickson, Robert Edward Farrell, Gary Leong, Jeffrey Paley, Seth Yakatan
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