Lorus Therapeutics announced recently that it has initiated a phase III trial to evaluate the macrophage activator Virulizin for the treatment of advanced pancreatic cancer. The company will present the results of this trial to the US Food and Drug Administration (FDA) in a new drug application at the completion of the study.
The double-blind randomized clinical trial will be conducted at approximately 40 medical centers in North America with the goal of enrolling 350 patients with advanced pancreatic cancer. Patients will be randomized to receive either gemcitabine(Drug information on gemcitabine) (Gemzar) or gemcitabine in combination with Virulizin. Patients who fail or become refractory to gemcitabine will be treated with fluorouracil(Drug information on fluorouracil) (5-FU) or 5-FU in combination with Virulizin.
"This final stage of Virulizin clinical testing is predicated on an ongoing clinical database of solid efficacy and safety data," said Dr. Jim A. Wright, chief executive officer at Lorus. "We endeavor to provide pancreatic cancer patients with increased survival coupled with improved quality of life through the availability of a promising therapeutic approach with little or no toxicity.
In a meta-analysis of three earlier phase I/II trials, Virulizin proved to be well-tolerated, increased the survival rate of patients, and maintained their quality of life. Preclinical data demonstrated that the immunotherapeutic agent exhibited strong antitumor activity in a variety of human tumor models. For example, tumors resistant to treatment with gemcitabine remained responsive to Virulizin.
An estimated 32,300 new cases of pancreatic cancer are diagnosed in North America each year. Of these, approximately 32,000 are expected to result in death.