Oragenics Reports Positive Interim Safety Analysis Results from Its Phase 2 Clinical Trial of AG013 for Oral Mucositis

Oragenics (NYSE:OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis (OM), today announced positive results from its interim safety analysis as requested by FDA on patients from its Phase 2 clinical trial of AG013 for the treatment of OM. The study provides information that, we believe, likely indicates that the overall incidence of severe OM is less than would be anticipated in the general population.

As quoted in the press release:

The Phase 2 trial is a double-blind, placebo-controlled, 2-arm, multi-center trial in which approximately 200 patients will be randomized in a 1:1 ratio to receive either placebo or AG013. Safety was evaluated on the basis of treatment-emergent adverse events, vital signs, weight, physical examinations, clinical laboratory assessments and the presence of AG013 in whole blood. Tolerability measures (taste, consistency and smell) were collected from the patient diaries. In addition, the reasons for study treatment discontinuation were also summarized. To date, 24 patients have been randomized and 19 patients included in the safety evaluation.

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