Topical administration of a novel mouth rinse, AG013, appears safe, well tolerated, and effective in reducing the severity and course of oral mucositis (OM) in patients receiving induction chemotherapy in a study presented at the 2012 ASCO Annual Meeting (Abstract 9024).
AG013 is a mouth rinse composed of a recombinant Lactococcus lactis engineered to secrete human trefoil factor 1 (hTFF1) and deficient in the gene encoding thymidylate synthase. TFFs have wound-healing properties and are protective of mucosal tissues. The compound was evaluated in 25 patients who developed symptomatic oral mucositis after induction chemotherapy for head and neck cancer in a phase 1B, multicenter, single-blind, placebo-controlled study reported by Sewanti Atul Limaye, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts.
Three dosing cohorts were evaluated and compared with placebo recipients. Patients receiving AG013 on any dosing schedule had a lower percentage of days with OM and fewer unplanned office and emergency room visits compared with patients who received placebo. Responses (≤1 day of ulcerative OM) were observed in 29% of AG013 patients but in none of the placebo patients. Ulcerative OM was observed during 35% to 40% of study days for patients receiving the mouth rinse, compared with 60% of study days in the placebo group. The absolute reduction in the percentage of days with ulcerative OM, with the use of the novel mouth rinse, was 35%. No differences were noted in mouth and throat soreness, opioid use, or gastrostomy tube placement.