Oragenics announces HDEC submission for Phase II concussion trial

Oragenics (OGEN) announced that it has submitted a clinical trial protocol for regulatory review to the Health and Disability Ethics Committee, HDEC, in New Zealand. This submission marks a critical milestone in advancing the Company’s Phase II clinical trial evaluating ONP-002, its proprietary neurosteroid therapy, for the treatment of mild traumatic brain injury or concussion. Pending approval, Oragenics expects to initiate patient enrollment in the region and expand the study’s geographic reach. The trial is expected to be conducted at Christchurch Hospital in New Zealand, the largest tertiary, teaching, and research hospital on the South Island. Christchurch Hospital provides a full range of emergency, acute, elective, and outpatient services, and its Emergency Department is one of the busiest in Australasia, treating more than 83,000 patients annually.