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Helix BioPharma Receives Approval to Initiate Phase II Pharmacokinetic Clinical Study of Topical Interferon Alpha-2b in Patients with Low-Grade Cervical Lesions
AURORA, Ontario, March 16 /CNW/ -- Helix BioPharma Corp. (TSX, FSE: "HBP") announced that it has ...
About this update from Helix Biopharma Corp.
[{"type":"text","content":"\n\n\n\nAURORA, Ontario, March 16 /CNW/ -- Helix BioPharma Corp. (TSX, FSE:\n"HBP") announced that it has received the necessary regulatory approvals in\nGermany to initiate its planned Phase II pharmacokinetic study of Topical\nInterferon Alpha-2b in patients with low-grade cervical lesions.\n\n\n\n\n\nThe clinical study was designed, as mandated by regulatory authorities,\nto gather data on the absorption and elimination profile of Topical Interferon\nAlpha-2b in patients with low-grade cervical lesions, in addition to further\ndata on its safety and efficacy. Depending on the data generated in the\nstudy, it is expected that interim results, which Helix anticipates will be\nreceived during its fiscal fourth quarter 2009, will allow the company to\nproceed with its planned regulatory filings in the U.S. and Europe\nrespectively for its future Phase IIb and Phase III pivotal efficacy trials\nfor this indication.\n\n\n\n\n\n"This clinical study will build upon our previous clinical findings and\nincrease our understanding of the drug's pharmacokinetic profile in patients\nwith low-grade cervical lesions," said John Docherty, president of Helix\nBioPharma. "Receiving the necessary approvals to commence this study is a\nsignificant step as we continue to advance the clinical development of Topical\nInterferon Alpha-2b for this important therapeutic indication."\n\n\n\nAbout the Clinical Study\n\n\n\nThe primary objective of the clinical study is to determine the\nmultiple-dose pharmacokinetic profile of Topical Interferon Alpha-2b following\nintravaginal application every other day of a total of 14 doses of the cream. \nFollowing the pharmacokinetic portion of the trial, assessment of efficacy and\nsafety parameters will continue until 35 doses of the cream have been applied.\nAs such, the clinical study is designed to also provide support for the dosing\nregimen intended to be applied in the future to U.S. Phase IIb and European\nPhase III pivotal efficacy trials for this indication.\n\n\n\n\n\nThe clinical study will be an open-label, single-arm trial in 28 female\npatients. Eligible women will be between 18 and 45 years of age and will\npresent with a cytological diagnosis of Pap IIID, a colposcopic diagnosis of\nmild to moderate cervical dysplasia and confirmed human papilloma virus\n("HPV&qu...