Helix BioPharma receives approval to start phase II study of topical interferon alpha-2b in low-grade cervical lesions

Helix BioPharma Corp. announced that it has received the necessary regulatory approvals in Germany to initiate its planned Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions.

The clinical study was designed, as mandated by regulatory authorities, to gather data on the absorption and elimination profile of Topical Interferon Alpha-2b in patients with low-grade cervical lesions, in addition to further data on its safety and efficacy. Depending on the data generated in the study, it is expected that interim results, which Helix anticipates will be received during its fiscal fourth quarter 2009, will allow the company to proceed with its planned regulatory filings in the U.S. and Europe respectively for its future Phase IIb and Phase III pivotal efficacy trials for this indication.

"This clinical study will build upon our previous clinical findings and increase our understanding of the drug's pharmacokinetic profile in patients with low-grade cervical lesions," said John Docherty, president of Helix BioPharma. "Receiving the necessary approvals to commence this study is a significant step as we continue to advance the clinical development of Topical Interferon Alpha-2b for this important therapeutic indication."

About the Clinical Study

The primary objective of the clinical study is to determine the multiple-dose pharmacokinetic profile of Topical Interferon Alpha-2b following intravaginal application every other day of a total of 14 doses of the cream. Following the pharmacokinetic portion of the trial, assessment of efficacy and safety parameters will continue until 35 doses of the cream have been applied. As such, the clinical study is designed to also provide support for the dosing regimen intended to be applied in the future to U.S. Phase IIb and European Phase III pivotal efficacy trials for this indication.

The clinical study will be an open-label, single-arm trial in 28 female patients. Eligible women will be between 18 and 45 years of age and will present with a cytological diagnosis of Pap IIID, a colposcopic diagnosis of mild to moderate cervical dysplasia and confirmed human papilloma virus ("HPV") positive status.

The clinical study will be conducted under the direction of Prof. Dr. med. Achim Schneider M.P.H., a world expert in the field of cervical cancer and Director of the Department of Gynecology at the Charite University Hospital in Berlin, Germany. The clinical portion of the study is expected to be completed during the first half of the 2010 calendar year.

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 which cause degradation of viral RNA, and by mobilizing the body's natural immune system to destroy the infected cells. Interferon alpha-2b, which has been commercially available for over 20 years, has been widely used by physicians as a treatment for certain HPV induced lesions, but is not generally favored due to the fact that conventional administration requires painful intradermal injection by a medical professional. Furthermore, intradermal injection is restricted to visible lesion administration, while HPV infection is often characterized by both visible and non-visible (i.e., sub-clinical) lesions. Helix's Topical Interferon Alpha-2b is expected to offer a safe, discreet, self-administered, pain-free therapy that can be broadly applied across a wide treatment surface area. Helix anticipates that this will prove highly advantageous not only from a patient compliance perspective, but also from an efficacy standpoint, by offering a new means of targeting both visible and sub-clinical lesions and treating cervical infection that was previously impractical to treat via injection.