On April 15, 2020 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported that early top-line results of the company’s Phase 2 clinical trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients did not demonstrate statistical significance on the primary endpoint of severe oral mucositis duration when compared to placebo (Press release, Oragenics, APR 15, 2020, View Source [SID1234556355]). AG013 was found to be safe based on review of topline adverse event information.

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Alan Joslyn, Ph.D., president and CEO of Oragenics stated, "We have now received the first cut of top line results for the study of AG013 in the prevention of oral mucositis in chemoradiation treatment of head and neck cancer. The results are equivocal in relation to the efficacy outcomes and we now await a more detailed ongoing analyses to determine if there may be potential efficacy for sub-patient populations, which we expect over the coming weeks."