Helix BioPharma has announced that its Phase II trial of topical interferon alpha-2b for the treatment of ano-genital warts has completed patient enrollment, with the required 120th patient randomized to enter the trial.

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The double-blind and placebo-controlled Phase II trial is under way 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.

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.

"This is an important milestone for our clinical program," says John Docherty, president of Helix BioPharma. "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."

Moving forward, based on the trial design and schedule, Helix expects patients to complete all study procedures by the early part of 2010, followed thereafter by closing of the database, analysis of the results and final reporting in mid to late 2010.

Ano-genital warts result from human papillomavirus infection of the external genitalia and can manifest as outwardly visible growths of varying sizes and shapes in both men and women. Each year in the United States alone, there are over 750,000 new cases of ano-genital warts.

Treatment options are limited by tolerability issues such as pain, irritation, and swelling at the treatment site. Treatments may include topical preparations, intralesional injection of interferon Alpha-2b, and surgically ablative procedures. Helix believes that more effective and better-tolerated treatments are needed.

Interferon alpha-2b is an immune system modulator that is active against a variety of HPV-induced lesions. Interferon alpha-2b is thought to function by triggering an antiviral response within infected cells by activating certain intracellular enzymes that cause degradation of viral RNA and by mobilizing the body's natural immune system to destroy the infected cells. Interferon alpha-2b has been widely used commercially as a treatment for ano-genital warts caused by HPV, but is not generally favored because conventional administration requires painful intralesional injection by a medical professional. Furthermore, intralesional injection is restricted to visible lesion administration, while HPV infection is often characterized by both visible and nonvisible lesions.