Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection

Inclusion Criteria:

- Women, 25 to 50 years old.

- Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy
with no evidence of invasive cancer in any specimen and must be p16+.

- Able and willing to abstain from sexual intercourse for 48 hours prior to first dose
and 2 days after each dose.

- Generally experiencing regular menstrual cycles, unless using long-acting reversible
contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).

Exclusion Criteria:

- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating
females.

- History of cancer, except basal cell or squamous cell carcinoma of the skin.

- History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal
infection.

- Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.

- History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of
CIN, or hysterectomy.