Solana Beach, CA, July 19, 2022 (GLOBE NEWSWIRE)-Artelo Biosciences, Inc. (Nasdaq: ARTL), A clinical-stage pharmaceutical company focused on regulating lipid signaling pathways to develop treatments for people with cancer, pain, and neurological conditions today in the Cancer Appetite Recovery Study (CAReS) Announced completion of enrollment for the first three cohorts. Start of the fourth cohort, which is expected to complete the first phase of the Phase 1b clinical trial of ART 27.13.
“The CAReS Safety Review Board reviewed previous data and concluded that ART 27.13 is well tolerated and there are no serious adverse events resulting from the investigational drug in patients suffering from cancer-related anorexia. I added it, “says Steven D. Reich. Chief Medical Officer of MD, Artelo. “Notably, the safety profile of ART 27.13 appears to be benign among cancer patients participating in CAReS than that observed in healthy volunteers in previous Phase 1 trials. In addition, there was a pharmacokinetics consistent with the experience of AstraZeneca and an improvement in appetite loss with each dose escalation. “
The CAReS Phase 1b stage focuses on the safety of increasing doses with the aim of identifying the optimal dose for the randomized Phase 2a portion of the study in which additional safety and activity are assessed. The mild to moderate adverse events observed in CAReS due to ART 27.13 did not require dose reduction or termination, and many of the adverse events did not require any medical intervention. With the aim of maximizing the potential usefulness of ART27.13, considering the promising safety profile and dose-response trends to date, Artelo has 650 micrograms per approved research protocol option. We chose to start enrollment of 6 patients at the dose of.
Gregory D. Gorgas, President and Chief Executive Officer of Artelo, said: “With six sites participating in three countries, we plan to efficiently complete Phase 1b of CAReS in the third quarter and launch randomized Phase 2a in the fourth quarter of this year. Will include additional sites in Europe and the United Kingdom. Kingdom. ”
About ART27.13
ART27.13 is a highly potent, peripherally restricted synthetic dual G protein-coupled receptor agonist that is thought to target the cannabinoid receptor CB.1 And CB2, May increase appetite and food intake. Originally developed by AstraZeneca plc, ART 27.13 participated in five Phase 1 clinical trials involving more than 200 subjects who showed a statistically significant and dose-dependent increase in body weight of healthy subjects. increase. Importantly, changes in body weight are not associated with fluid retention, and drug distribution allows for systemic metabolic effects while minimizing central nervous system-mediated toxicity. Artelo is promoting ART 27.13 as supportive care for cancer patients suffering from loss of appetite and weight loss, and the current annual global market is estimated to exceed $ 2 billion.
About CAReS
The Cancer Appetite Recovery Study (CAReS) is a phase 1b / 2a randomized placebo-controlled trial of ART 27.13, our leading clinical program, in patients with cancerous anorexia and weight loss. Loss of appetite, or lack or loss of appetite in a cancer patient, may result from cancer and / or its treatment with radiation or chemotherapy. It is common for cancer patients to lose weight. Loss of appetite and associated weight loss often affect the patient’s health, weaken the immune system, and cause discomfort and dehydration. Weight loss of more than 5% may predict poor outcomes and reduced response to chemotherapy in cancer patients. The Phase 1b portion of the CAReS study is designed to determine the most effective and safest dose of ART 27.13 for administration during Phase 2a. Part of Phase 2a of the CAReS study is designed to determine estimates of ART 27.13 activity in terms of improving lean body mass, weight gain, and anorexia. (ISRCTN Registry: https://www.isrctn.com/ISRCTN15607817).
About Artelo Biosciences
Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company specializing in the development and commercialization of unique therapies that regulate lipid signaling pathways, including the endogenous cannabinoid system. Artelo promotes a portfolio of widely applicable product candidates designed to address critical unmet needs in multiple diseases and conditions, including loss of appetite, cancer, anxiety, pain, neuropathy, and inflammation. doing. Headed by a proven biopharmacy executive working with acclaimed researchers and technical experts, the company applies cutting-edge science, regulation, and commercial disciplines to deliver influential therapies. I am developing. For more information, please visit www.artelobio.com and Twitter (@ArteloBio).
Description of future prospects
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