Topical NVN1000 for the Treatment of External Genital and Perianal Warts

This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose
study to assess safety, tolerability and efficacy of a topical nitric oxide releasing
compound in subjects with external genital and perianal warts. Eligible subjects will be
treated with a topical gel (active or vehicle) for up to 12 weeks.

Inclusion Criteria:

- At least 2 but not more than 20 genital/perianal warts with a maximum total wart
surface area no more than 1% body surface area

- If a woman of child-bearing potential, have a negative pregnancy test and use
effective contraception

- If currently receiving wart treatment, be willing to stop all treatment for 28 days
prior to randomization and during the study

Exclusion Criteria:

- Immunocompromised patients including those with HIV, receiving radiation, or drugs
that suppress the immune system

- Pregnant, planning to become pregnant, or nursing

- History of cancer (including cervical cancer) within 5 years, with exception of
non-melanoma skin cancer in non-genital skin

- Recent history of other genital skin infections

- Active HSV and frequent HSV recurrences unless receiving suppression therapy

- Have hemoglobin < 10 G/dl or methemoglobin > 3%

- Known allergy to any component of the gel including excipients

- Previously participated in any study with NVN1000 or SB204