The Helix BioPharma Corporation has 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.
Human papilloma viruses (HPVs) are a large group of related viruses. They play a part in the development of cervical epithelial cancers. HPV is also associated with skin, oral and anal cancers.
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It says that its study showed a clinically efficacious response to the topical interferon treatment in nearly half of the treated patients. In addition, the product demonstrated an excellent safety profile, with no significant adverse side-effects.
Prof. Dr. Achim Schneider, a renowned expert in the field of cervical cancer and Director of the Department of Gynaecology at the Charité University Hospital in Berlin, said, . "Helix's product shows real promise as a practical and effective pharmaceutical means of preventing cervical cancer development in women affected by HPV-induced cervical lesions."
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.
Nearly half (46.7%) of the women in the treated 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).
In a PAP test cells from the cervix are collected for examination under a microscope. It is used to detect changes that may be cancer or may lead to cancer. It is named after George Papanicolaou, an American anatomist. "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. Immune modulation is a new emerging field in the medical treatment of viral infections. It works by introducing an agent into the body that boosts specific areas of the immune system.
Interferon alpha-2b is thought to function by triggering an antiviral response within infected cells and by mobilizing the body's natural immune system to destroy the infected cells.
Helix's Topical Interferon Alpha-2b is expected to offer a safe, discreet, self-administered and pain-free therapy.