Kalytera Therapeutics, Inc. (TSXV: KALY) (OTCQB: KALTF), a clinical-stage pharmaceutical company developing cannabinoid therapeutics for Graft versus Host Disease (“GvHD”), today announced that it has received approval from the Institutional Review Board (“IRB”) at one of two clinical sites in Israel to commence a Phase 2 study to evaluate cannabidiol (“CBD”) for the prevention of GvHD.
The proposed study is a Phase 2, open label, multicenter trial to evaluate the pharmacokinetic profile, safety, and efficacy of multiple doses of CBD for the prevention of GvHD following allogeneic hematopoietic cell transplantation (“HCT”). The proposed study will take place at the Rabin Medical Center, Beilinson, and the Rambam Health Care Campus, Haifa, in Israel.
Kalytera has received approval from the IRB at Beilinson to commence the Phase 2 study and expects to receive similar approval from the IRB at Rambam shortly.
“This study is the next step in our development program designed to obtain FDA approval of CBD in the prevention of GvHD,” said Robert Farrell, President and Interim CEO of Kalytera. “The Phase 2 study is designed to generate the pharmacokinetic and safety data, at multiple dose levels, that will be required by the FDA as we seek to advance towards a pivotal Phase 3 clinical study.”
Mr. Farrell continued, “Kalytera has assembled a world-class team to lead our program in the prevention of GvHD. The present Phase 2 study will be directed by Moshe Yeshurun, M.D., Director of the Bone Marrow Transplantation Department, Davidoff Center, Rabin Medical Center, Beilinson Hospital. Dr. Yeshurun will be the principal investigator of the study. Dr. Yeshurun was also the principal investigator in four prior clinical studies evaluating CBD in the prevention and treatment of GvHD that were conducted at Beilinson Hospital.”
Dr. Yeshurun was advised in the design of the Phase 2 study by a team of experts in the field of GvHD, including Daniel Couriel, M.D., M.S., Director of the Bone Marrow Transplant program at the University of Utah Health Sciences, School of Medicine; 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.
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.
Kalytera Therapeutics is a clinical-stage pharmaceutical company developing 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 proprietary cannabidiol (“CBD”) prodrugs intended for commercialization as FDA and EMEA-approved prescription medications. CBD has shown activity against a number of pharmacological targets. However, there are limitations associated with CBD, including its poor oral bioavailability. Kalytera’s CBD prodrugs have been designed to overcome these limitations. In addition to licensed IP rights, Kalytera has filed composition of matter and method of use patents covering its inventions to reinforce its position in the market.
This news release contains “forward-looking information” within the meaning of applicable securities laws, including in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives, management goals, capital raising abilities and other statements included in this news release of a forward-looking nature. 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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