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Helix Biopharma Corp. completes Phase 2 clinical study with Topical Interferon Alpha-2B in patients with low-grade squamous intraepithelial lesions
Helix Biopharma Corp. completes Phase 2 clinical study with Topical Interferon Alpha-2B in patients with low-grade squamous intraepithelial lesions.
About this update from Helix Biopharma Corp.
[{"type":"text","content":"\n\n\n\n\n>\n\nAURORA, ON, Nov. 14 /CNW/ - Helix BioPharma Corp. (TSX, FSE: \"HBP\")\nannounced today completion of enrollment and treatment in its Phase 2 clinical\nstudy of Topical Interferon Alpha-2b in women with low-grade squamous\nintraepithelial lesions (\"LSIL\") that are positive for human papilloma virus\n(\"HPV\") infection.\nThe study was designed to evaluate the safety and effectiveness of\nTopical Interferon Alpha-2b in patients with cytologically confirmed LSIL and\npolymerase chain reaction (\"PCR\") confirmed HPV. Patients received Topical\nInterferon Alpha-2b therapy applied intravaginally three times a week for a\nperiod of six weeks, followed by a six week follow-up period. The primary\nstudy endpoint is to determine the proportion of patients with resolution of\ntheir abnormal Pap smear during the twelve week study duration. Other study\nassessments include safety and tolerability, pre- and post-study histological\nexaminations by way of colposcopy and qualitative assessment of HPV-positive\nstatus using PCR. In addition, the Company studied a second patient population\nthat received no treatment whatsoever as a comparator to the treatment\npopulation.\nAs planned, 40 patients were enrolled across the two patient groups,\ndivided into 20 patients in each group. No serious adverse drug reactions were\nreported in the study. The Company is completing analytical work on patient\nsamples collected over the duration of the patient testing and will be\ngathering and analyzing the final data. The Company expects to complete all\ndata analyses and report the final integrated study findings during the first\nquarter of calendar 2007.\nThe Phase 2 study was conducted at four clinical sites in Germany under\nthe guidance of Prof. Achim Schneider, MD, MPH, a world expert in the field of\ncervical cancer. Prof. Schneider is the Director of the Department of\nGynecology at one of the largest university hospitals in Europe, The\nCharitDe-Universitatsmedizin Berlin.\n\nAbout Topical Interferon Alpha-2b\n\nInterferon alpha-2b is an immune system modulator that is active against\na variety of HPV-induced lesions. Interferon alpha-2b is thought to function\nby triggering an antiviral response within infected cells, by activating\ncertain intracellular enzymes which cause degradation of viral RNA, and by\nmobilizing the body's ...