A Randomized, Placebo-Controlled Phase II Study of Multiple Dosing Regimens of Intravaginally Administered 851B Gel for the Treatment of Cervical High Risk HPV Infection

Inclusion Criteria:

- A female subject of childbearing potential who is sexually active using
contraception.

- Subject is willing to abstain from all sexual contact involving her genitalia for at
least 24 hours prior to and 24 hours after study drug administration.

- Subject must be neither pregnant nor lactating from Screening throughout the duration
of the study.

- Subject has 1 of the following:

- Menstruating with a stable cycle and has at least 21 non-bleeding days.

- Amenorrheic (due to injectable or extended-cycle contraceptives).

- Subject is willing to refrain from using vaginal douche products during the treatment
period and through the Follow-up Month 4 visit.

- Subject has a Pap test interpretation of either low-grade squamous intraepithelial
lesions or atypical squamous cells of undetermined significance.

- Subject has a uterine cervical sample that is high-risk human papillomavirus
positive.

Exclusion Criteria:

- The Subject has evidence of an uncontrolled, clinically significant medical condition
as determined by the investigator.

- The Subject has a history of hemorrhagic diatheses or coagulopathy.

- The Subject has a history of toxic shock syndrome.

- The Subject has received any of the following medications in the timeframes listed
below:

- 851 (in any form) or an active (non-placebo) human papillomavirus vaccine at any
time prior to the screening visit.

- In the 4 weeks prior to the screening visit the subject has received:

- Interferon therapy or other therapies that promote a proinflammatory immune
state, including:

- immunomodulators.

- cytotoxic drugs.

- drugs known to have major organ toxicity.

- Used a vaginal douche 72 hours prior to the screening visit.

- Received any investigational drug within 60 days of Study Day 1.

- Used in the 2 weeks prior to Study Day 1:

- oral or inhaled corticosteroids (>1000 mcg/day, fluticasone propionate
>600 mg/day, or equivalent).

- systemic steroids.

- topical drugs to the anogenital area.

- NuvaRing.

- The Subject has a history of hypersensitivity to any components of the gel
formulation or to iodine.

- The Subject has given birth or has had a spontaneous or induced abortion within 2
months of Study Day 1.

- The Subject uses an intrauterine device, diaphragm, NuvaRing, or additional
contraceptive foam or gel for birth control.

- The Subject has:

- histology read as high-grade cervical intraepithelial neoplasia.

- cytology read as high-grade squamous intraepithelial lesion.

- cytology read as atypical glandular cytological abnormalities.

- cytology read as atypical squamous cells - cannot exclude high grade.

- cervical carcinoma of any type.

- apparent endocervical involvement.

- high-grade vulvar intraepithelial neoplasia.

- high-grade vaginal intraepithelial neoplasia.

- If the limits of a cervical lesion cannot be readily visualized.

- If the limits of the transformation zone cannot be readily visualized.

- The subject has clinical evidence of a vaginal infection or sexually transmitted
infection, other than cervical human papillomavirus infection at the Study Day 1
visit.

- The Subject has had a cervical biopsy within 1 month prior to the screening visit.

- The Subject has had any previous ablative or surgical treatment of the cervix within
3 months prior to the screening visit;

- The Subject has a history of alcoholism or substance abuse within 1 year or has
current alcohol or substance abuse as assessed by the investigator.

- The Subject has tested positive for human immunodeficiency virus at the screening
visit or has evidence of any other immunosuppressive disease.