Helix BioPharma Corp. announces positive phase II clinical results with its Topical Interferon Alpha-2b

04-Apr-2007

Helix announced positive results from its phase II clinical study of its Topical interferon Alpha-2b in women with human papilloma virus (HPV) induced low-grade cervical lesions. The study showed a clinically efficacious response to treatment in nearly half of the treated patients. In addition, the product demonstrated an excellent safety profile, with no significant local intolerance or drug-related serious adverse event observations.

"Treated patients responded well, both in terms of efficacy and safety to this new investigational therapeutic," said Prof. Dr. med. Achim Schneider M.P.H., Director of the Department of Gynaecology at the Charité University Hospital in Berlin. "Helix's product shows real promise as a practical and effective pharmaceutical means of preventing cervical cancer development in women presenting with HPV-induced cervical lesions", continued Prof. Schneider.

A total of 41 women with cytologically confirmed, HPV-induced low-grade squamous intraepithelial lesions (LSIL) of the cervix were studied across four sites in Germany. Twenty women received Topical Interferon Alpha-2b, self-administered intravaginally three times per week for a period of 6 weeks with a follow-up evaluation at 12 weeks, compared with 21 separately studied women who received no treatment whatsoever over the same study period.

The primary endpoint and main outcome for both groups was the Pap-response rate defined as the proportion of patients with resolution of their abnormal Pap smear LSIL cytology to normal during the 12 week study duration. Pap smear normalization was considered to occur if the patient's Pap smear improved to group II or better from any of Pap smear groups IIW through IIID as per the common European standard, "Munich Classification System" of LSIL cytology. Pap smear testing is a leading method to diagnose potentially precancerous cervical disease caused by HPV in women today.

Nearly half (46.7%) of the women in the treated per-protocol population had their abnormal Pap smears revert to normal during the 12 week period, compared with only 15.8% of the untreated women (i.e., nearly a three-fold improvement). Of these women, one treated patient's LSIL cytology returned following the end of treatment, which suggests that a longer dosing regimen may be advisable in future studies.

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