Helix BioPharma announced today the opening of two additional German sites for the Phase II clinical trial of its Topical Interferon Alpha-2b product at the Charité Berlin, one of the largest university hospitals in Europe.
The sites will fall under the direction of Professor Achim Schneider, MD, MPH, the principal investigator for the study, and are expected to begin enrolling patients immediately.
"We are pleased to add these new clinical sites," said Dr. Don Segal, President and CEO of Helix BioPharma. "The opening of these new sites grants us access to expanded clinical resources and a larger pool of potential patients for this trial."
The study, which began in November 2004 at the Friedrich-Schiller- University in Jena, Germany, is designed to evaluate the efficacy and safety of Topical Interferon Alpha-2b in the treatment of women with low-grade squamous intraepithelial lesions ("LSIL") that are positive for human papilloma virus ("HPV") infection. LSIL represents the mild-to-moderate forms of cervical dysplasia, which may progress to cervical cancer in women.
In the United States alone, an estimated one million women annually are diagnosed with LSIL. At present, there is no pharmaceutical therapy available to these patients. The trial is scheduled for completion in 2006.