Helix initiates Ph II trial of INF cream

Canadian drugmaker Helix BioPharma Corp has initiated patient enrollment in a Phase II clinical trial of its topical formulation of interferon alpha-2b for the treatment of ano-genital warts associated with human papilloma virus infection.

The trial, which will take place in Sweden, will assess the efficacy and safety of the agent compared with placebo using a double-blind, randomized design over an examination period of four months per patient. 120 patients will be enrolled in the trial. Only female subjects will be recruited in order to avoid inter-sex treatment variations.

Trial subjects will self-administer the topical INF alpha-2b twice daily for five consecutive days per week over a treatment period of eight weeks, with a follow-up visit at 16 weeks. The primary endpoint for the trial will be comparison of the proportion of patients with complete clearance of their baseline lesions during the eight-week treatment period.