VANCOUVER, BC / ACCESSWIRE / January 18, 2017 / Kalytera Therapeutics, Inc. (TSX-V: KALY) ("Kalytera") today announced preliminary results of a 12 patient Phase 2a study evaluating the safety and efficacy of prolonged use of cannabidiol ("CBD") in the prevention of Graft versus Host Disease ("GvHD"). Preliminary results of the study demonstrate that only 15% of patients in the CBD treatment group developed Grade 2-4 GvHD, as compared to a 60-70% incidence predicted by historical data used as a control. The study was conducted by Talent Biotechs ("Talent"), a privately held, Israeli-based developer of CBD therapeutics.

Kalytera previously announced that it has entered into a binding letter of intent to acquire Talent and its Phase 2 program in GvHD.

GvHD is an orphan disease that can arise following allogeneic hematopoietic cell transplantation ("HCT"). GvHD occurs when the transplanted donor cells attack the patient's organs, including the skin, gastrointestinal tract, liver, lungs, eyes, oral cavity, heart, nervous system and other organs. GvHD is associated with acute and chronic illness, infections, disability, reduced quality of life, and death. The ability to prevent GvHD is a major unmet need. Despite prophylactic immunosuppressive treatment, GvHD remains a major cause of mortality following HCT.

In 2015, Dr. Moshe Yeshurun, Chief Medical Officer of Talent, published the results of a prior Phase 2a clinical trial evaluating the safety and efficacy of CBD in the prevention of acute GvHD1. Based on the promising results of that study, Talent commenced the present Phase 2a clinical study to evaluate the efficacy of prolonged administration of CBD following HCT. In this study, which enrolled 12 patients, participants were provided daily doses of CBD seven days prior to transplantation and for 100 days following the procedure. With a median follow up of 8.5 months following transplantation, results demonstrate that 85% of the patients did not develop significant (Grades 2-4) acute GvHD, despite the fact that the majority of the patients (10) received stem cells from unrelated donors, including five patients who received stem cells from non-fully matched donors. Only 15% of patients developed grade 2-4 GvHD, versus the predicted incidence of 60-70% in the scientific literature, potentially representing a more than four-fold reduction.

"The results of these clinical studies are outstanding, and mark a major milestone in the potential prevention of this serious and disabling disorder following HCT," said Dr. Andrew Salzman, CEO of Kalytera Therapeutics.

Talent also completed additional pilot studies exploring the use of CBD in treatment of GvHD, including treatment of acute and chronic GvHD. Following the anticipated completion of the Talent acquisition, Kalytera will initiate planning for placebo-controlled, double blind, randomized studies of CBD for both the prevention and treatment of GvHD. These clinical studies may support U.S. Food and Drug Administration ("FDA") Breakthrough Therapy and Fast Track Designations, which could accelerate the regulatory approval process.

About Graft versus Host Disease

A hematopoietic stem cell transplantation ("HCT") is a procedure where the stem cells of the bone marrow or peripheral blood of a healthy donor are transplanted into a new host after chemotherapy or radiation. This is a lifesaving procedure for many diseases of the blood and bone marrow including leukemia, Hodgkin and Non-Hodgkin lymphoma, multiple myeloma, sickle cell anemia, and thalassemia. There were over 8,000 HCT procedures in the U.S. in 20142 and the use of HCT procedures is expected to continue to increase. While HCT procedures can be lifesaving, they pose many dangerous side effects, including infection and GvHD.

GvHD is a multisystem disorder that occurs when the transplanted cells from a donor ("the graft") recognize the transplant recipient ("the host") as foreign. This interaction initiates an immune reaction that causes disease in the transplant recipient. This reaction can occur within days after the transplant (acute GvHD) or months to years after HCT (chronic GvHD).

GvHD can be mild, moderate, severe, and even life threatening. Patients with acute GvHD may suffer from rashes and blistering of the skin, nausea, vomiting, abdominal cramps accompanied by diarrhea, and jaundice. Generally, acute reactions are more severe and life threatening.

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