The study was designed to evaluate the safety and effectiveness of topical interferon alpha-2b in patients with cytologically confirmed low-grade squamous intraepithelial lesions and human papilloma virus infection (HPV). Patients received topical interferon alpha-2b therapy applied three times a week for a period of six weeks, followed by a six week follow-up period. The primary study endpoint is to determine the proportion of patients with resolution of their abnormal Pap smear during the twelve week study duration.
No serious adverse drug reactions were reported in the study. The company expects to complete all data analyses and report the final integrated study findings during the first quarter of calendar 2007.
Interferon alpha-2b is thought to function by triggering an antiviral response within infected cells, by activating certain intracellular enzymes which cause degradation of viral RNA, and by mobilizing the body's natural immune system to destroy the infected cells.