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news.Phase II trial is undergoing at multiple centers in Germany and Sweden
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Helix BioPharma has completed patient enrollment in its phase II trial of Topical Interferon Alpha-2b for the treatment of ano-genital warts (AGW), with the required 120th patient randomized to enter the trial.
The company said that the double-blind and placebo-controlled phase II trial is underway at multiple centers in Germany and Sweden. Patients participating in the trial self-administer active treatment or control cream to the external ano-genital region twice-daily, for five consecutive days per week over a treatment period of eight weeks, with a follow-up visit at 16 weeks.
According to Helix BioPharma, only female subjects were enrolled in the trial in order to avoid inter-sex treatment variations. The trial was designed to enroll 120 patients, whereby half were intended to receive Topical Interferon Alpha-2b and the other half a vehicle cream intended to serve as a placebo control. 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.
Reportedly, based on the trial design and schedule, the company expects patients to complete all study procedures by the early part of calendar 2010, followed thereafter by closing of the database, analysis of the results and final reporting in mid to late calendar 2010.
John Docherty, president and COO of Helix BioPharma, said: “This is an important milestone for Helix’s Topical Interferon Alpha-2b clinical program. Our efforts to enhance the recruitment rate over recent months have been successful, and we now look forward to obtaining the results of this trial once all patient procedures and analyses are completed.”
According to the company, Interferon Alpha-2b is an immune system modulator that is active against a variety of HPV-induced lesions. It 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.