Helix completes Ph II trial of topical INF-alpha

Canada's Helix BioPharma has completed patient enrollment and treatment in a Phase II clinical study of its topical interferon alpha-2b in women with low-grade squamous intra-epithelial lesions that are positive for human papilloma virus infection.

The study was designed to evaluate the safety and effectiveness of the agent in patients with cytologically-confirmed LSIL and polymerase chain reaction-confirmed HPV. Patients received the topical therapy applied intravaginally three times a week for a period of six weeks, followed by a six-week follow-up. The primary study endpoint is to determine the proportion of patients with resolution of their abnormal Pap smear during the 12-week study duration. Other study assessments include safety and tolerability, pre- and post-study histological examinations by way of colposcopy and qualitative assessment of HPV-positive status via PCR.

As planned, 40 patients were enrolled across the two patient groups, divided into 20 in each cohort. No serious adverse drug reactions were reported in the study and Helix is now completing analytical work on the data it has gathered. The firm expects to report the final, integrated study findings during the first quarter of next year.