Independent DSMB Approves Dose Escalation for Second Cohort in Phase 2 Clinical Study
Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced additional positive interim 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.
Kalytera previously announced, on December 20, 2018, that no patients in the Phase 2 clinical study had developed grades 3 or 4 acute GVHD while receiving oral CBD treatment, and that only one patient had developed grade 2 acute GVHD. The Company is announcing today that, during the 6 weeks following the previous announcement, no additional patients have developed GVHD of any grade.
“These interim results are encouraging,” stated Robert Farrell, President and CEO of Kalytera. “Our goal is to diminish the risk of developing GVHD that cancer patients face when choosing to undergo a bone marrow transplant procedure, and we believe that CBD has the potential to become the first pharmaceutical to be approved for prevention of GVHD.”
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 is also announcing today that, based on the absence of significant adverse events, as well as the safety and tolerability data seen in the first 12-patient cohort, the independent data safety monitoring board (“DSMB”) has approved dose escalation for the second 12-patient cohort at a dosage level twice that administered to patients in the first cohort. The DSMB is an independent group of physicians with expertise in 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 twice daily (“BID”).
The study is enrolling a total of 36 patients in three 12-patient cohorts. The first cohort is the low dose cohort, with patients in this cohort receiving the 75 mg BID dose. Enrollment of the first cohort is complete, although all 12 patients in this cohort have not yet completed the entire 105-day course of treatment with CBD. The final patient in the first cohort is scheduled to complete the 105-day course of treatment on February 28th.
It is anticipated that the Phase 2 study will complete later this year, and that it will provide support for the planned Phase 3 study that the Company expects to initiate in late-2019.
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 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 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 is expressly qualified by this cautionary statement and is 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.