Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous
 cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the
 safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.
This is a randomized, double-blind, placebo-controlled study. It will randomize patients in a
 1:1 ratio to topical cervical treatment with A-007, or placebo gel. Following biopsy
 confirmation of High Grade Squamous Intraepithelial Lesions (HSIL), women will treat
 themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply
 gel once daily for 5 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.
Inclusion Criteria:

 Patients may be enrolled in the study only if they meet all of the following criteria:

 -  18 years of age or older

 -  The patient or her authorized representative must sign and date an Ethical Review
 Board-approved informed consent document. All aspects of the protocol must be
 explained and written informed consent obtained.

 -  Patients must have histological proof of HSIL (CIN 2/3) disease documented.

 -  Cervical swabs must test positive for HPV (by Hybrid Capture 2).

 -  Patients must have a Hb ≥ 9 g/dl, a peripheral WBC ≥ 3000 mm3 and platelet counts ≥
 100,000 mm3.

 -  Normal hepatic and renal functions - AST and ALT < 2.5 x ULN and creatinine < 1.5 x
 ULN, respectively.

 -  Females of childbearing potential must use one of the following birth control methods
 during the treatment period and 2 weeks thereafter: oral, implantable, injectable
 contraceptives; abstinence (celibacy). Contraceptive sponges, IUD, spermicides,
 sponges, condoms, or partner's vasectomy are not acceptable methods of birth control.

 Exclusion Criteria:

 Patients will be excluded from the study for any of the following preexisting reasons:

 -  Patients with LSIL (CIN 1) or invasive squamous cell carcinoma (SCC).

 -  SIL (CIN) involving the endocervix as determined by endocervical curettage, or
 otherwise not amenable to adequate colposcopic follow-up evaluations, i.e.
 unsatisfactory colposcopy.

 -  CIN 3 involving more than two cervical quadrants on colposcopy.

 -  Patients treated for cervical SIL within the past year.

 -  Patients with other malignancy (except for non-melanoma skin) within the past 5 years.

 -  Patients with any active infections (including HIV) other than HPV.

 -  Patients with known clinically relevant immunological deficiency.

 -  Concurrent treatment with cytotoxic, radiation, or immuno-stimulative therapy, or with
 systemic corticosteroids at a dose of > 5 mg/d of prednisone (or its equivalent).

 -  Participation in another investigational medication trial concurrently or within 30
 days, or prior participation in an HPV vaccine trial. Treatment within the last 30
 days with a medication that has not received regulatory approval at the time of study
 entry.

 -  Concomitant use of topical vaginal medications.

 -  Significant acute or chronic medical or psychiatric illness that, in the judgment of
 the Investigator, could compromise subject safety, limit the subject's ability to
 complete the study, and/or compromise the objectives of the study.

 -  History of allergy or hypersensitivity to cosmetics, toiletries, or other topical or
 dermatologic products.

 -  Pregnant or lactating females who are nursing and will not consent to cease nursing.

 -  Investigators, site personnel directly affiliated with this study, and their immediate
 families. Immediate family is defined as a spouse, parent, child or sibling, whether
 biological or legally adopted.