Inovio Pharmaceuticals (NASDAQ:INO) has completed target enrollment of 198 participants for its Phase 3 registration trial (“REVEAL 1”) of VGX-3100, a DNA-based immunotherapy being tested to treat cervical dysplasia caused by human papillomavirus (HPV).
A confirmatory Phase 3 trial (REVEAL 2) is currently enrolling with FDA submission expected in 2021.
The primary endpoint of the Phase 3 study is regression of cervical HSIL and virologic clearance of HPV 16 and/or HPV 18 in the cervix.
The studies will evaluate cervical tissue changes at approx. 9 months after beginning a three dose regimen administered at months 0, 1, and 3.
Shares are up 5% premarket.
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