Oragenics announced early top-line results from a Phase 2 clinical trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients. The trial did not demonstrate statistical significance on the primary endpoint of severe oral mucositis duration when compared to placebo. AG013 was found to be safe.
The company is waiting for an ongoing detailed analysis to determine if there may be potential efficacy for sub-patient populations, which they expect over the coming weeks.
The phase 2 trial was a double-blind, placebo-controlled, 2-arm, multi-center trial in which subjects were randomized in a 1:1 ratio to receive either placebo or topically-applied AG013. Tye primary endpoints were efficacy of AG013 compared to placebo for reducing OM as measured by the duration and time to development of OM during the active treatment phase, efficacy of AG013 compared to placebo for reducing OM as measured by the overall incidence of OM during the active treatment phase and safety and tolerability.
AG013 is made up of genetically modified (GM) bacteria called Lactococcus lactis (L. lactis). Wild type L. lactis are commonly used to produce dairy products including cheeses and milk. To make AG013, the DNA of L. lactis has been changed in the laboratory to secrete a protein called human Trefoil Factor 1 (hTFF1). hTFF1 is normally secreted in saliva and intestines. Trefoil factors have been shown to be important in protecting and healing mucosal tissues, such as the tissue in the mouth, when these tissues are damaged by cancer therapies such as chemotherapy and radiation therapy.