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Helix BioPharma Corp. announces positive phase II clinical results with its Topical Interferon Alpha-2b
Helix BioPharma Corp. announces positive phase II clinical results with its Topical Interferon Alpha-2b.
About this update from Helix Biopharma Corp.
[{"type":"text","content":"\n\n\n\nAURORA, ON, April 2 /CNW/ - Helix BioPharma Corp. (TSX: HBP/Frankfurt:\nWKN 918864)\n\n\nHelix today announced positive results from its phase II clinical study\nof its Topical Interferon Alpha-2b in women with human papilloma virus (HPV)\ninduced low-grade cervical lesions.\n\n\nThe study showed a clinically efficacious response to treatment in nearly\nhalf of the treated patients. In addition, the product demonstrated an\nexcellent safety profile, with no significant local intolerance or\ndrug-related serious adverse event observations.\n\n\n"Treated patients responded well, both in terms of efficacy and safety to\nthis new investigational therapeutic," said Prof. Dr. med. Achim Schneider\nM.P.H., a world expert in the field of cervical cancer and Director of the\nDepartment of Gynaecology at the Charite University Hospital in Berlin.\n"Helix's product shows real promise as a practical and effective\npharmaceutical means of preventing cervical cancer development in women\npresenting with HPV-induced cervical lesions", continued Prof. Schneider.\n\n\nAbout the Clinical Study\n\n\nA total of 41 women with cytologically confirmed, HPV-induced low-grade\nsquamous intraepithelial lesions (LSIL) of the cervix were studied across four\nsites in Germany. Twenty women received Topical Interferon Alpha-2b,\nself-administered intravaginally three times per week for a period of 6 weeks\nwith a follow-up evaluation at 12 weeks, compared with 21 separately studied\nwomen who received no treatment whatsoever over the same study period.\n\n\nThe primary endpoint and main outcome for both groups was the\nPap-response rate defined as the proportion of patients with resolution of\ntheir abnormal Pap smear LSIL cytology to normal during the 12 week study\nduration. Pap smear normalization was considered to occur if the patient's Pap\nsmear improved to group II or better from any of Pap smear groups IIW through\nIIID as per the common European standard, "Munich Classification System" of\nLSIL cytology. Pap smear testing is a leading method to diagnose potentially\nprecancerous cervical disease caused by HPV in women today.\n\n\nNearly half (46.7%) of the women in the treated per-protocol population\nhad their abnormal Pap smears revert to normal during the 12 week period,\ncompared with only 15.8% of the untre...