Strong Ph II data for Helix' topical INF-alpha-2b

Canadian drugmaker Helix BioPharma has reported positive results from a Phase II study of its topical interferon alpha-2b in women with human papilloma virus-induced low-grade cervical lesions. The trial showed a clinically-efficacious response to treatment in nearly half of treated patients and also demonstrated an excellent safety profile, with no significant local intolerance or drug-related serious adverse event observations, the firm noted.

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. 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. 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, Helix noted.