The trial, which is taking place in Sweden, will assess the efficacy and safety of topical interferon alpha-2b compared with placebo over an examination period of four months per patient. Only female subjects are to be enrolled in the trial in order to avoid inter-sex treatment variations.
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.
“Ano-genital warts represent the second major target indication to be sought for our Topical Interferon Alpha-2b, to hopefully build upon its broad utility as a topical treatment for HPV-induced skin/mucosal lesions,” said John Docherty, vice president of Corporate Development for Helix BioPharma.
Helix has contracted the services of Encorium Group, a multi-national, full-service contract research organization with local offices in Sweden, to assist Helix in managing the conduct and evaluation of the trial.