Benzinga | Jun 22, 2021 08:14AM EDT

Artelo Biosciences Highlights 2 Poster Presentations At 31st Annual International Cannabinoid Research Society Symposium, Jun. 22, 23

Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that target lipid-signaling pathways, including the endocannabinoid system, today announced that a poster featuring the ART27.13 Cancer Appetite Recovery Study (CAReS) will be presented today, June 22, at the 31st Annual International Cannabinoid Research Society (ICRS) Symposium, which is being held virtually from June 21-24, 2021. Artelo's cannabinoid agonist, ART27.13, is being developed as a therapy for cancer patients suffering from anorexia and weight loss, which affects over 60% of later-stage cancer patients, often impacting quality of life and hastening death.

The Company also announced that a poster featuring the latest ART12.11 data will also be presented on June 23 at ICRS. ART12.11 is Artelo's proprietary cannabidiol:tetramethylpyrazine (CBD:TMP) solid state composition, the first and only CBD cocrystal to have an issued composition of matter patent from the US Patent and Trademark Office.

"We are honored to have both posters related to our product candidates selected for presentation at the highly prestigious ICRS Symposium," commented, Gregory Gorgas, President and Chief Executive Officer of Artelo. "As we continue to make important progress on both of these programs, we look forward to reporting stage 1 results from the CAReS trial, as well as in vivo data related to our CBD cocrystal."

Cancer Appetite Recovery Study ("CAReS") Poster Presentation

Study Protocol for a Dose-Ascending, Multicenter, Randomized ControlledTitle: Phase 1/2 Trial of ART27.13 in Patients with Cancer Anorexia and Weight LossDate: Tuesday, June 22, 2021Authored by Dr. Barry Laird, coordinating investigator of CAReS; Dr. StevenReich, Chief Medical Officer of Artelo; Dr. Andrew Yates, Chief ScientificOfficer of Artelo, and presented by Dr. Yates.

The CAReS poster forms the first of a series of publications on the Phase 1/2 study, which describes the study design and the background rationale of using ART27.13, a peripherally selective CB1/CB2 receptor agonist, in this cancer population suffering from anorexia. CAReS is a two stage, randomized, double-blind, placebo-controlled clinical trial designed to investigate the utility of ART27.13 in cancer anorexia and weight loss. The first stage of the study will determine the optimal dose of ART27.13 to be used in the Phase 2 randomized study. As previously announced, the first patient was enrolled and initiated daily dosing on April 12, 2021, and the study continues to enroll. Artelo expects to report the Phase 1 results of the CAReS trial in the fourth quarter of 2021.

According to the poster's authors, ART27.13 represents a novel mechanism-based strategy to stimulate appetite and weight gain known to arise from CB1 receptor activation that could significantly benefit patients with cancer anorexia. For the broader community, the data that will arise from this study will help elucidate the potential of modulating the peripheral cannabinoid system in the control of appetite and weight, and inform the development strategies for trials targeting this underserved patient group.

CBD:TMP Cancer Abstract Related to Artelo's Cocrystal

Title: The Effects of CBD and TMP Coadministration in CancerDate: Wednesday, June 23, 2021Presented and authored, in part, by Prof. Saoirse O?Sullivan, scientificadvisor to Artelo and former Professor of Pharmacology at the University ofNottingham, UK.

Cannabidiol (CBD) and tetramethylpyrazine (TMP) have anti-cancer properties in vitro and in vivo. However, both suffer from poor oral bioavailability. ART12.11, a cocrystal of CBD and TMP, could confer the new solid form with a more desirable pharmacokinetic profile, with the added potential for positive pharmacodynamic interactions. In this cell-based study, the effects of CBD and TMP coadministration were investigated in cancer cell lines.

The investigation found that there were synergistic and additive interactions between CBD and TMP in their ability to prevent cancer cell growth and to kill cancer cells. There was a small reduction in the anti-migratory effect of CBD when TMP was present.

The authors concluded that the positive initial studies warrant further in vivo preclinical research in animal tumor models, where an additional pharmacokinetic interaction could be expected, leading to improved drug exposure with the CBD:TMP cocrystal compared to either molecule alone.