PHILADELPHIAResults of a phase I/II study showed that Virulizin, an investigational monocyte and macrophage activator, has clinical activity in treating advanced pancreatic cancer comparable to that of gemcitabine(Drug information on gemcitabine) (Gemzar) and with a much better safety profile, Changnian Liu, MD, PhD, of the University of Nebraska Medical Center, reported at the annual meeting of the American Association for Cancer Research.
Virulizin, developed by Lorus Therapeutics, Toronto, is isolated from bovine bile and has demonstrated a significant antitumor activity against several tumor types, including pancreatic cancer, melanoma, and AIDS-associated lymphoma, he said.
A total of 26 patients with advanced pancreatic cancer who had failed standard therapies were entered into the phase I/II study conducted at Rush-Presbyterian-St. Lukes Medical Center, Chicago. The 19 evaluable patients were treated with different dose levels of Virulizin (1.5, 3.0, 6.0 mL three times a week, and 3.0 mL five times a week) for at least 4 weeks. The maximum dose level was well tolerated, Dr. Liu said.
Of the 19 evaluable patients, 7 (37%) had stable disease, and one achieved a complete response, he said. The patients had a median survival of 6.7 months with a 6-month survival rate of 58%, and they showed a significant improvement in quality of life, Dr. Liu said.
He concluded, Our results show the activity of Virulizin against pancreatic cancer is comparable to that of the current best chemotherapeutic drug treatment (gemcitabine) and that it is well tolerated by patients. However, additional studies are needed to evaluate the effect of Virulizin treatment in all patients with pancreatic cancer, and not just those with advanced disease.
Future efforts, he added, should focus on randomized, controlled, phase III trials to evaluate the effectiveness of Virulizin, either as a single agent or in combination with other therapeutic modalities.