A randomized, phase 1, placebo-controlled trial of APG-157 in oral cancer demonstrates systemic absorption and an inhibitory effect on cytokines and tumor-associated microbes
Cancer Feb 13, 2020
Basak SK, Bera A, Yoon AJ, et al. - Considering that curcumin's effect on head and neck cancer is limited by poor systemic absorption from oral administration, researchers investigated the efficacy of APG-157, a botanical drug containing multiple polyphenols, including curcumin, developed under the US Food and Drug Administration's Botanical Drug Development, that delivers the active components to oromucosal tissues near the tumor target. They conducted a double-blind, randomized, placebo-controlled, phase 1 clinical trial with APG-157 randomizing 13 normal individuals and 12 patients with oral cancer to receive two doses, 100 mg or 200 mg, delivered transorally every hour for 3 hours. The blood samples and the tumor tissues from individuals with oral cancer exhibited the presence of curcumin following administration of oral APG-157. A decrease in the inflammatory markers and Bacteroides species was observed in the saliva, and an increase in immune T cells was noted in the tumor tissue. These findings suggest well absorption of APG-157; it led to a reduction in inflammation, and attracted T cells to the tumor, inferring its possible use in combination with immunotherapy drugs.
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