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.
Lorus Therapeutics announced recently thatit has initiated a phase III trial to evaluate the macrophage activatorVirulizin for the treatment of advanced pancreatic cancer. The company willpresent 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 atapproximately 40 medical centers in North America with the goal of enrolling 350patients with advanced pancreatic cancer. Patients will be randomized to receiveeither gemcitabine (Gemzar) or gemcitabine in combination with Virulizin.Patients who fail or become refractory to gemcitabine will be treated withfluorouracil (5-FU) or 5-FU in combination with Virulizin.
"This final stage of Virulizin clinical testing ispredicated on an ongoing clinical database of solid efficacy and safetydata," said Dr. Jim A. Wright, chief executive officer at Lorus. "Weendeavor to provide pancreatic cancer patients with increased survival coupledwith improved quality of life through the availability of a promisingtherapeutic 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 theimmunotherapeutic agent exhibited strong antitumor activity in a variety ofhuman tumor models. For example, tumors resistant to treatment with gemcitabineremained responsive to Virulizin.
An estimated 32,300 new cases of pancreatic cancer are diagnosedin North America each year. Of these, approximately 32,000 are expected toresult in death.