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 (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