Oragenics completes enrollment of Phase 2 clinical trial for AG013 in OM
Oragenics announced the completion of enrollment in its ongoing double-blind, randomized, placebo-controlled Phase 2 trial of its lead product candidate, AG013, an easy to use oral rinsing system designed to prevent and treat oral mucositis, or OM. The ongoing Phase 2 trial is a double-blind, placebo-controlled, two-arm, multi-country, multi-center trial, in which 200 patients have been randomized in a 1:1 ratio to receive either AG013 or a placebo. The purpose of the study is to evaluate the safety, tolerability and efficacy of topically administered AG013 compared to placebo for reducing the incidence and severity of OM in patients undergoing traditional chemoradiation, or CRT, for the treatment of head and neck cancer, or HNC. Key measures include duration, time to development, and overall incidence of OM during the active treatment phase, which begins from the start of chemoradiation therapy and ends two weeks following its completion.