The Food and Drug Administration recently granted fast-track status to the new immunotherapy agent, Virulizin developed by Lorus Therapeutics for the treatment of advanced pancreatic cancer.  The designation of fast-track status fastens the review process of an agent prior to approval and is intended for life-threatening diseases. Virulizin is an agent that stimulates the body?s immune system to fight cancer. Virulizin is isolated from bovine bile and is thought to produce anti-cancer effects through a few mechanisms. Virulizin appears to stimulate the release of a substance, called tumor necrosis factor, by cancer cells, which stimulates certain immune cells called macrophages to attack the cancer cells. In addition, Virulizin may induce death of cancer cells through mechanisms still being investigated.

An earlier-phase clinical trial evaluating Virulizin in the treatment of pancreatic cancer was conducted by researchers from the Rush Presbyterian St Luke?s Medical Center in Chicago, Illinois. This trial involved patients with advanced pancreatic cancer who had received therapy before. The average survival of these patients was 6.8 months, with 58% of patients still alive at six months. In addition, Virulizin was well tolerated. 

The last phase of clinical trials prior to FDA approval evaluating Virulizin for pancreatic cancer has been initiated. In this trial, patients with advanced pancreatic cancer will receive treatment with Gemzar alone or Gemzar plus Virulizin. Patients who stop responding to Gemzar will then be treated with 5-FU (5-Fluorouracil) with or without Virulizin. Patients with advanced pancreatic cancer may wish to speak with their physician about the risks and benefits of participating in a clinical trial evaluating Virulizin or other promising therapies.