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.
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. Nearly half, 46.7%, of the women in the treated per-protocol population had their abnormal Pap smears revert to normal, compared with only 15.8% of the untreated women.
Beyond the Pap-response rate efficacy parameter, all other efficacy parameters evaluated showed the same tendency in favor of treatment. For example, 60% of the treated women experienced resolution of their associated abnormal cervical findings upon colposcopic diagnosis versus only 9.5% 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 which cause degradation of viral RNA, and by mobilizing the body’s natural immune system to destroy the infected cells.