Study is Part of Program Evaluating CBD for Prevention of GVHD
Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced that it has completed Study KAL-07, the Food Effect and QTc Study, that is part of the Company’s product development program evaluating cannabidiol (“CBD”) for the prevention of acute graft versus host disease (“GVHD”).
Preliminary Study Results
Preliminary results for the Food Effect and QTc Study are positive and as expected. CBD was well tolerated, there were no safety concerns and the EKG data that is required to evaluate the effects of CBD on cardiac rhythm have been obtained.
“We are very pleased to have completed the Food Effect and QTc Study,” stated Robert Farrell, President and CEO of Kalytera. “We are making good progress with our program developing CBD for the prevention of GVHD, and we anticipate that we will announce significant developments later this month.”
Study KAL-07, the Food Effect and QTc Study
Kalytera conducted Study KAL-07, the Food Effect and QTc Study, pursuant to written guidance received from the U.S. Food and Drug Administration (the “FDA”).
The FDA required that the Company complete a study in healthy volunteers to assess the effect of food intake on the absorption of oral CBD. The Food Effect and QTc Study was a double blind, randomized, two period, two treatment, fixed sequence, crossover (fed versus fasted) study that evaluated the effect of food on the pharmacokinetics of CBD in 32 healthy volunteers. The study was conducted at a single site in Melbourne, Australia.
FDA guidelines also require that a proposed new drug be evaluated for its effects on cardiac rhythm. This evaluation is typically done in a separate study known as a QT or QTc study. To save time and expense, Kalytera included a robust EKG evaluation of each subject enrolled in the study. By including this evaluation in the design of the study, the Company was able to complete the collection of this critical data, without having to initiate a separate QT or QTc study for this purpose.
Study KAL-08, the Drug-Drug Interaction Study
Study KAL-08, the Drug-Drug Interaction Study, is a second healthy volunteer study that has been requested by the FDA. This study will measure the effect of certain anti-fungal drugs upon metabolism of CBD, and the Company anticipates that it will complete this study during the fourth quarter this year. This study is also being conducted at a single site in Melbourne, Australia.
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.
The Potential of CBD to Improve Outcomes in Bone Marrow Transplantations
Bone marrow transplantation procedures are among the most successful treatments available to patients with refractory, stage 4 blood cancers, such as lymphoma, leukemia or multiple myeloma. This procedure is intended to cure these forms of cancer, and it has boosted survival rates from nearly zero to more than 85 percent for some blood cancers. However, patients receiving bone marrow transplants are at high risk of developing GVHD, and there are currently no FDA approved therapies for the prevention of acute GVHD. The Company believes that CBD has potential to become the first pharmaceutical approved for prevention of acute GVHD following bone marrow transplantation.
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.