Oragenics has resumed its Phase ll clinical trial of AG013 for the treatment of oral mucositis (OM), after a positive review carried out by the trial’s independent Data Safety Monitoring Board (DSMB).
The review follows the positive interim safety analysis results, which were based on the first 19 patients of the trial and revealed in May this year.
The patients were examined on the basis of treatment-emergent adverse events, vital signs, weight, physical examination, clinical laboratory assessment, as well as the potential presence of AG013 in blood.
Various tolerability measures such as taste, consistency and smell were gathered from patient diaries.
After the positive review, the independent DSMB recommended the trial to proceed with no necessary changes.
Oragenics president and CEO Alan Joslyn said: “Based on the DSMB’s positive review, and using funds recently raised through a public offering, we are now expanding our Phase ll trial to up to 45 additional centres in the US and EU in order to rapidly accelerate patient enrolment.
“With our reinforced cash position, we look forward to completing the trial next year while concurrently advancing our lantibiotic programme.”
The ongoing Phase ll trial is a double-blind, placebo-controlled, two-arm, multi-centre trial that intends to enrol around 200 patients.
During the course of the trial, the patients will be randomised in a 1:1 ratio to receive either AG013 or placebo.
The trial’s objective is to evaluate the safety, tolerability and efficacy of topically administered AG013 compared to placebo for minimising the incidence and severity of OM in patients undergoing traditional chemoradiation for the treatment of head and neck cancer.
Key measures of the trial comprise duration, time to development, and overall incidence of OM as per the World Health Organization scale throughout the active treatment phase, which begins from the start of chemoradiation until two weeks following its completion.