Biopharmaceutical company Helix BioPharma (TSX: HBP) (NYSE Amex: HBP) (FSX: HBP) said Thursday it received positive results from the recently completed phase II trial of its topical treatment for potentially pre-cancerous cervical lesions.
Using a colposcopic biopsy to determine the drug's effectiveness, it was found that following treatment of Topical Interferon Alpha-2b, 71.4% of women in the study no longer had potentially pre-cancerous, low-grade lesions, known as CIN 1 or CIN 2. The trial enrolled 14 females between the ages of 18 to 45, with mild to moderate CIN.
According to the American Journal of Obstetrics and Gynecology, there are approximately 1.3 million women diagnosed with CIN 1 or CIN 2 lesions each year in the U.S. alone. Currently, there are no non-surgical treatments for these women, and the surgical options available are sometimes associated with serious unwanted side effects, including cervical complications with pregnancy and conception.
As a result, clinical management of these lesions typically involves protracted waiting with frequent Pap smears, HPV testing and biopsies. Surgical methods are only really used in the case of long-term persistance and or progression of the lesions after a period of several months, leading to a large amount of stress for the patient.
Topical Interferon alpha-2b is an antiviral cream that acts against HPV, which can often lead to cervical cancer. It can be self-applied intravaginally using a vaginal applicator.
The phase II study also tested the Pap smear response rate as a secondary parameter in patients. Helix said the findings were less pronounced, with 35.7% of the women having no more abnormal Pap smears.
The company said, however, that it was not surprised with this result, as the study was designed for a short post-treatment follow-up period, mainly meant to examine the mechanisms of absorption and administration of the drug.
In addition to the Pap smear results, the study found that the treatment had an "excellent" safety profile, with no significant intolerance and no serious adverse effects.
"These findings suggest that Topical Interferon Alpha-2b could offer women a safe and immediate therapeutic alternative to today's protracted observational and potentially problematic surgical approach to managing this disease," said president John Docherty.
The company is now awaiting approval by the US FDA for its application to conduct an expanded U.S. phase II/III efficacy trial.