Helix Announces Positive Data on Topical HPV Treatment

Helix BioPharma has announced positive results from a Phase II clinical study of its topical interferon alpha-2b in women with low-grade cervical lesions caused by human papillomavirus (HPV).

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 events.

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 three times per week for a period of six weeks with a follow-up evaluation at 12 weeks, and 21 women received no treatment 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 testing is a leading method to diagnose potentially precancerous cervical disease caused by HPV in women, according to Helix.

Nearly half 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 percent of the untreated women. Beyond the Pap response rate, all other efficacy parameters evaluated showed the same tendency in favor of treatment. For example, 60 percent of the treated women experienced resolution of their associated abnormal cervical findings upon colposcopic diagnosis versus only 9.5 percent of the untreated women.

Interferon alpha-2b is an immune system modulator that is active against a variety of HPV-induced lesions. Interferon alpha-2b is thought to function by triggering an antiviral response within infected cells by activating certain intracellular enzymes that cause a degradation of viral RNA, and by mobilizing the body's natural immune system to destroy the infected cells.