Oragenics Resumes Phase 2 Clinical Trial of AG013 in Oral Mucositis Following Positive Routine Safety Review

Oragenics (NYSE:OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis (OM), today announced it has resumed its Phase 2 clinical trial of AG013, a live biotherapeutic product for the potential treatment of OM following a positive review by an independent Data Safety Monitoring Board (DSMB).

As quoted in the press release:

“Based on the DSMB’s positive review, and using funds recently raised through a public offering, we are now expanding our Phase 2 trial to up to 45 additional centers in the US and EU in order to rapidly accelerate patient enrollment,” stated Alan Joslyn, president and CEO of Oragenics, Inc. “With our reinforced cash position, we look forward to completing the trial next year while concurrently advancing our lantibiotic program.”

In May 2018, Oragenics reported positive interim safety analysis results based on the first 19 patients, which were evaluated on the basis of treatment-emergent adverse events, vital signs, weight, physical examination, clinical laboratory assessment and the potential presence of AG013 in blood. Tolerability measures (taste, consistency and smell) were collected from patient diaries. Following a routine data review, the trial’s independent DSMB concluded that it may proceed with no necessary changes to the study.

Click here to read the full press release.