Heman Chao
Chief Scientific Officer Helix BioPharma Corp 3-305 Industrial Parkway South Aurora ON. Canada

Abstract:

Currently there are no pharmaceutical treatments for millions of women diagnosed with potentially precancerous, HPV-induced CIN 1 or 2 lesions each year, and available invasive/surgical techniques are potentially associated with complications and side effects.  For these patients, clinical management usually consists of watchful waiting with frequent Pap smears, HPV testing, colposcopy and/or colposcopic biopsies, with invasive/surgical techniques utilized only in the case of long-term persistence and/or progression of the lesions.  As a result, patients may have to endure months or even years of observation and associated psychosocial stress before medical intervention is introduced..  Interferon alpha-2b is a potent immunomodulatory compound that has been previously shown to be effective against a variety of benign ans neoplastic skin lesions when administered by injection.  Topical Interferon Alpha-2b is a cream dosage form of recombinant interferon alpha-2b designed for easy use intravaginally where injectable drug administration is cumbersome.  Topical Interferon Alpha-2b uses Helix BioPharma Corp.’s proprietary Biphasix™ lipid vesicles to encapsulate, stabilize and formulate interferon alpha-2b for topical administration, using a vaginal applicator for convenient self-application by patients.  Topical Interferon Alpha-2b has been assessed in two open label Phase II studies in patients with low-grade cervical lesions, and shown to be effective and well tolerated.  Using colposcopic directed biopsy to determine the treatment’s effectiveness, 71.4% of the women in the most recently completed study no longer had CIN 1 or 2 lesions following treatment.  Helix is currently in the process of pursuing regulatory authorizations for the final pivotal efficacy trial stage of development for this novel product candidate.