The opening of additional sites in Germany is intended to compensate for a lower than expected patient enrollment rate thus far in Sweden. These sites have been added in order to speed the pace of enrollment to support Helix’s objective of completing patient enrollment by the end of the company’s fiscal fourth quarter, ending July 31, 2009.
The trial is designed to assess the efficacy and safety of Topical Interferon Alpha-2b compared with placebo using a double blind, randomized design over an examination period of four months per patient. Approximately 120 patients are to be enrolled in the trial. Half will receive a placebo and half will receive Topical Interferon Alpha-2b. Only female subjects are to be enrolled in the trial in order to avoid inter-sex treatment variations.
Trial subjects will self-administer Topical Interferon 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.
John Docherty, president of Helix BioPharma, said: “We are pleased to have received approval to open these additional clinical sites. The opening of sites in Germany will grant us access to expanded clinical resources and a larger patient pool in order to enhance the recruitment rate of our trial.”