LORUS COMPLETES PHASE III TRIAL OF VIRULIZIN IN COMBINATION THERAPY
Lorus has completed a Phase III clinical study of Virulizin in combination with Gemzar for the treatment of pancreatic cancer.
The Phase III clinical registration study started in early 2002 and enrolled 436 patients at more than 100 clinical sites in North America and Europe. The study compared the efficacy and safety of Virulizin when combined with Gemzar versus a placebo combined with Gemzar in patients with locally advanced or metastatic pancreatic cancer. The primary efficacy endpoint was overall survival, while secondary endpoints included progression of symptoms of pain, deterioration of performance status and weight loss.
Virulizin has been granted fast track and orphan-drug status in the U.S. and Europe, and a special protocol assessment by the FDA in advanced pancreatic cancer.