Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced positive data from its ongoing Phase 2 clinical study evaluating cannabidiol (“CBD”) for the prevention of acute graft versus host disease (“GVHD”) following bone marrow transplant.
The clinical study criteria that are used to determine the efficacy of CBD in prevention of acute GVHD are:
- Disease free survival at Day 100 after bone marrow transplant;
- Disease free survival at Day 180 after bone marrow transplant;
- Cumulative incidence of grade 2-4 acute GVHD at Day 100 after bone marrow transplant; and
- Cumulative incidence of grade 2-4 acute GVHD at Day 180 after bone marrow transplant.
To date, 3 of the 12 patients in the first cohort have died from causes unrelated to GVHD. The data for the remaining 9 patients demonstrate encouraging preliminary evidence of efficacy as measured by each of the above listed outcome endpoints:
- Disease free survival at Day 100: Eight of the 9 surviving patients are disease free (no evidence of grades 2-4 acute GVHD) at Day 100;
- Disease free survival at Day 180: Three patients are now more than 180 days post bone marrow transplant, and each of these patients is disease free;
- Cumulative incidence of grade 2-4 acute GVHD at Day 100: The cumulative incidence of grades 2-4 acute GVHD at Day 100 is encouraging, with only one patient having developed grade 2 acute GVHD, the least serious form of the disease, prior to Day 100; and
- Cumulative incidence of grade 2-4 acute GVHD at Day 180: The cumulative incidence of grades 2-4 acute GVHD at Day 180 is encouraging, with only one patient having developed grade 2 acute GVHD, and with none of the surviving patients who are now more than 180 days post bone marrow transplant having developed grades 2-4 acute GVHD.
In summary, no patients in the first cohort of the Phase 2 clinical study have developed grades 3 or 4 acute GVHD while receiving oral CBD treatment, and only one patient developed grade 2 acute GVHD.
“We are very encouraged by these excellent results,” stated Robert Farrell, President and CEO of Kalytera. “The first cohort in our Phase 2 study is the low dose cohort, with patients receiving only 75 mg of CBD twice daily (“BID”). We did not anticipate that the results for the low dose cohort would be as positive as they are. We are now enrolling the second 12-patient cohort. The patients in the second cohort will receive 150 mg of CBD BID.”
The results of the first cohort are in line with data from the two earlier Phase 2a clinical studies that were completed by Dr. Moshe Yeshurun, Kalytera’s Chief Medical Officer, at the Institute of Hematology, Davidoff Center, Rabin Medical Center, Petah Tikva, Israel. The results from the first of these clinical studies were published in Biology of Blood and Marrow Transplantation (Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study, M. Yeshurun et al. / Biology Blood Marrow Transplant 21 (2015) 1770 – 1775).
Bone marrow transplantation procedures are among the greatest success stories in cancer treatment. The vast majority of patients receiving bone marrow transplants are patients with various forms of blood cancers, such as leukemia, lymphoma or multiple myeloma, and bone marrow transplantation has boosted survival rates for some blood cancers from nearly zero to more than 85 percent. However, patients receiving bone marrow transplants are at high risk of developing acute GVHD, a life-threatening complication that occurs when the transplanted donor cells attack the patient’s organs, including the skin, GI tract, liver, lungs, and eyes.
It is estimated that up to 50% of patients who undergo a bone marrow transplant from a sibling donor, and up to 70% of patients who undergo a bone marrow transplant from an unrelated donor, will develop some level of GVHD. There are currently no FDA approved therapies for either the prevention or treatment of acute GVHD.
Kalytera’s Phase 2 clinical study is an open label, multicenter study to evaluate multiple doses of CBD for the prevention of acute GVHD following allogeneic hematopoietic cell transplantation, commonly referred to as bone marrow transplantation. The study will evaluate the PK profile, safety, and efficacy of CBD at doses of 75, 150, and 300 mg BID.
CBD is a non-psychotropic ingredient of cannabis that does not cause euphoria or cognitive effects. The formulation of CBD that Kalytera is evaluating for the prevention of acute GVHD is a proprietary formulation that is designed to improve product stability and absorption after oral dosing.
Kalytera is the exclusive licensee of two issued U.S. patents covering the use of CBD in the prevention and treatment of GVHD, and is also the exclusive licensee of pending patent applications in other jurisdictions for the use of CBD in the prevention and treatment of GVHD.
The U.S. FDA has recommended that Kalytera apply for both Breakthrough Therapy and Fast Track Designations for its CBD products for prevention and treatment of acute GVHD, each of which could accelerate the approval process for these products.
Kalytera Therapeutics, Inc. is pioneering the development of cannabidiol (“CBD”) therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for a range of important unmet medical needs, with an initial focus on GVHD and treatment of acute and chronic pain.
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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 applicable regulatory approvals will not be obtained or the risk that future clinical studies may not proceed as expected or may produce unfavourable results. 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.