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Artelo Biosciences Completes Enrollment of the First Three Cohorts in its CAReS Study Evaluating ART27.13 for the Treatment of Cancer-Related Anorexia and Weight Loss
Initiates Fourth Cohort at a 650-Microgram Dose with Data Expected in Q4 2022 SOLANA BEACH, Calif., July 19, 2022 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc.
About this update from Artelo Biosciences, Inc.
[{"type":"text","content":"Initiates Fourth Cohort at a 650-Microgram Dose with Data Expected in Q4 2022\nSOLANA BEACH, Calif., July 19, 2022 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced the completion of enrollment of the first three cohorts in the Cancer Appetite Recovery Study (CAReS) and the initiation of a fourth cohort expected to complete the first stage of the Phase 1b clinical trial of ART27.13. “The CAReS safety review committee has reviewed the data thus far and has concluded that ART27.13 has been well-tolerated with no serious adverse events attributable to the investigational drug in patients suffering from anorexia associated with cancer,” said Steven D. Reich, M.D., Chief Medical Officer of Artelo. “Remarkably, the safety profile of ART27.13 appears more benign among cancer patients participating in CAReS than observed in healthy volunteers in prior Phase 1 studies. Furthermore, we have seen pharmacokinetics consistent with the AstraZeneca experience and an improvement in anorexia from each dose escalation.” The CAReS Phase 1b stage focuses on the safety of ascending doses with the objective of identifying the optimal dose for the randomized Phase 2a portion of the study, in which additional safety and activity will be evaluated. The mild to moderate adverse events observed in CAReS that have been attributed to ART27.13 required no dose reductions or terminations and many of the adverse events required no medical intervention at all. Given the encouraging safety profile and dose-response trend to date, with the goal of maximizing potential utility of ART27.13, Artelo has elected to open enrollment for six patients at a 650 microgram dose per the option in the approved study protocol. “We remain highly encouraged by the clinical observations among the patients successfully enrolled in CAReS,” added Gregory D. Gorgas, President and Chief Executive Officer of Artelo. “With six participating sites in three countries, we expect to efficiently complete the Phase 1b stage of CAReS during the third quarter and initiate the randomized Phase 2a in the fourth quarter of this year, which is planned to include additional sites in Europe and the Unit...