Artelo Biosciences Receives Ethics Approval to Commence its Cancer Appetite Recovery Phase I/II Clinical Study (CAReS) of ART27.13 for the Treatment of Cancer-Related Anorexia
Barry J. A. Laird, M.D. of the University of Edinburgh’s Institute of Genetics and Molecular Medicine Appointed Coordinating Investigator
LA JOLLA, Calif., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that modulate the endocannabinoid system, today announced the receipt of Ethics Committee approval in the U.K. for the Company’s Cancer Appetite Recovery Study (CAReS) entitled A Phase 1/2 Trial of the Synthetic Cannabinoid ART27.13 in Patients with Cancer Anorexia and Weight Loss. Barry J. A. Laird, M.D. of the Institute of Genetics and Molecular Medicine at the University of Edinburgh and St. Columbia’s Hospice Reader in Palliative Medicine, will serve as the coordinating investigator. ART27.13 is a highly potent, peripherally restricted synthetic, dual cannabinoid agonist believed to target peripheral CB1/CB2 receptors, and has the potential to increase appetite and food intake. Artelo intends to initially develop ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss.
“Receiving Ethics Committee approval is an essential step towards commencing our CAReS trial in the UK,” stated Steven D. Reich, M.D., Artelo’s Chief Medical Officer. “We are very pleased to have Dr. Laird as our Coordinating Investigator as we believe that his extensive knowledge of and focus on palliative medicine as well as his direct expertise in clinical trials evaluating treatments for anorexia will be invaluable as we evaluate ART27.13. We are working diligently on securing the additional regulatory requisite approvals which will enable us to open our clinical sites and initiate patient enrollment later this year.”
"As an academic clinician, I am passionate about improving symptoms in people with life-limiting illness and I am honored to be working with Artelo on this exciting program and the CAReS clinical trial,” stated Dr. Laird. “My team’s overarching goal is to help find therapies which improve the care of patients with cancer and I look forward to evaluating the potential of ART27.13 to reduce the devastating symptoms and improve quality of life of those suffering from this disease."
About the CAReS Study
CAReS is a Phase 1/2 clinical trial of the synthetic cannabinoid ART27.13 in patients with cancer anorexia and weight loss, which will enroll up to 49 subjects, initially in clinical trial sites located in the U.K. The primary endpoint in Phase 1 of the study is to determine the most effective and safe dose of ART27.13 to be utilized in Phase 2. The primary endpoint in Phase 2 of the study is to determine point estimates of activity of ART27.13 in terms of lean body mass, weight gain, and improvement of anorexia.
ART27.13 is a potent, peripherally restricted dual synthetic agonist of the CB1/CB2 receptors. Existing ART27.13 clinical data suggests meaningful potential for the treatment of cancer-related anorexia and weight loss. In five Phase I clinical studies including over 200 subjects, ART27.13 previously demonstrated a statistically significant and dose-dependent increase in body weight in subjects without cancer. Artelo plans to advance ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss.
About Artelo Biosciences, Inc.
Artelo Biosciences, Inc. is a San Diego-based biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics targeting the endocannabinoid system. Artelo is rapidly advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, post-traumatic stress disorder, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and medical experts, the company applies leading edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @ArteloBio.
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Released September 29, 2020