Helix BioPharma, a Canada-based biopharmaceutical company, 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 US and Europe respectively for its future Phase IIb and Phase III pivotal efficacy trials for this indication.
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 US 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 positive status. The clinical portion of the study is expected to be completed during the first half of the 2010 calendar year.