A Two-Stage Phase 2 Study Of A-007 Topical Gel in High-Grade Squamous Intraepithelial Lesions (HSIL)

This is a non-randomized, two-stage phase II study with pathological response rate as the primary objective. Following biopsy confirmation of CIN 2/3 within the last 12 weeks, women will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply gel once daily for 14 consecutive days of a 28-day cycle for 2 cycles. Women will return to clinic for safety assessments, colposcopy, cytology, and virologic and immunologic testing (see schedule of events in attachment TG-003.01 for visit intervals). Following the two cycles of treatment with A-007, treating physicians will perform a LEEP at the month 4 visit. The investigator is responsible for ensuring that the LEEP is conducted according to the procedures and guidelines of their institution.