Helix BioPharma Corp. 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., a world expert in the field of cervical cancer and 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.
Furthermore, upon stratification of the patients according to the North American definition of LSIL cytology (i.e., "The Bethesda Classification System"), the relative difference in the Pap-response rate between the treated and untreated patient groups increased substantially. Using this approach, only those women who entered the study belonging to the Pap smear group IIID classification (i.e., the more advanced/serious Pap smear diagnosis described above) were evaluated. Of the women in the stratified per-protocol treatment population, 41.7% experienced normalization of their Pap IIID smear, whereas none (0.0%) of the untreated Pap IIID women experienced improvement.
Beyond the Pap-response rate efficacy parameter, all other efficacy parameters evaluated showed the same tendency in favour 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.
"We are very pleased to have achieved this milestone in the continuing development of our Topical Interferon Alpha-2b product candidate," said John Docherty, Helix's Vice President of Corporate Development. "Helix is committed to further advancing its clinical development program for this extremely prevalent condition, in order to bring this product to market as expeditiously as possible."
Interferon alpha-2b is an immune system modulator that is active against 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. Interferon alpha-2b has been widely used commercially as a treatment for certain HPV induced lesions, but is not generally favoured due to the fact that conventional administration requires painful intradermal injection by a medical professional. Furthermore, intradermal injection is restricted to visible lesion administration, while HPV infection is often characterized by both visible and non-visible (i.e., sub-clinical) lesions.
Helix's Topical Interferon Alpha-2b is expected to offer a safe, discreet, self-administered, pain-free therapy that can be broadly applied across a wide treatment surface area. Helix anticipates that this will prove highly advantageous not only from a patient compliance perspective, but also from an efficacy standpoint, by offering a new means of targeting both visible and sub-clinical lesions and treating cervical infection that was previously impractical to treat via injection.
Helix BioPharma Corp. is a biopharmaceutical company specializing in the field of cancer therapy. The company is actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies.