Oragenics (NYSE American:OGEN) has enrolled more than 80 patients in its Phase 2 trial of AG013 for the treatment of oral mucositis (OM). The company also reported that the WHO provided AG013 with the generic name dapatifagene navolactibac.
OM is a serious and debilitating breakdown of the mucosal lining of the mouth caused by chemotherapy and radiotherapy.
AG013 consists of bacteria that have been genetically modified to express human trefoil factor family 1, a peptide naturally secreted in saliva that creates a protective mucosal barrier and promotes epithelial regrowth.
The ongoing Phase 2 trial will enroll some 200 patients to evaluate the safety, tolerability and efficacy of the candidate, compared with placebo, for reducing the incidence and severity of OM in patients undergoing chemoradiation for head and neck cancer.
“We continue to increase the number of clinical sites across the globe with 48 of the 61 identified clinical sites actively enrolling patients for our Phase 2 clinical trial of AG013,” Dr. Alan Joslyn, Oragenics’ president and CEO, said in a statement.
Dapatifagene navolactibac has been granted fast track designation by the FDA and orphan drug status in Europe.
