Inovio Pharmaceuticals (NASDAQ:INO) reached target enrollment of 198 women for its pivotal Phase 3 trial for VGX-3100 for the treatment of cervical dysplasia caused by human papillomavirus (HPV).
VGX-3100 is a DNA-based immunotherapy designed to stimulate an immune response to HPV 16 and HPV 18 infection, and destroy pre-cancerous cells.
The primary endpoint of this Phase 3 trial, called REVEAL 1, is the regression of cervical lesions and virologic clearance of HPV 16 and/or HPV 18 in the cervix. The study will also provide one-year safety data for a minimum of 198 patients on VGX-3100, which will be administered in a three-dose regimen.
“This establishes an important milestone for the company as it brings Inovio another step closer to providing an innovative treatment alternative to the women suffering with cervical dysplasia for whom surgery is the only option today,” Dr. Joseph Kim, Inovio’s president and CEO, said in a statement.
Inovio is currently enrolling patients for a confirmatory Phase 3 trial, called REVEAL 2, to gather one-month safety data and support an FDA submission.
