Helix BioPharma Completes Phase II Trial Of Topical Interferon Alpha-2b

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.

Helix’s Topical Interferon Alpha-2b utilises the company’s proprietary Biphasix drug delivery technology, and is expected to offer a safe, discreet, self-administered and pain-free therapy that can be broadly applied across the entire affected tissue area.

The company said that all patients enrolled in the study have completed the prescribed study procedures, and Helix is now expected to proceed to closing of the database and analysis of the results. Based on the trial design and schedule, final reporting is expected in mid to late calendar 2010, as previously announced.

Reportedly, the double-blind and placebo-controlled Phase II trial was conducted at multiple centers in Germany and Sweden. Patients participating in the trial self-administered 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 to assess for lesion recurrence at 16 weeks.