Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. It is presented in vials as a sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil.

A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil.

Patients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.

• Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV)
• No previous systemic chemotherapy(unless given as a radiosensitizer).
• ECOG Performance Status 0-2
• Life expectancy equal to or greater than 12 weeks
• Adequate laboratory and organ functions
• Stabilizable pain (stable analgesic intake)
• No radiotherapy during 4 weeks prior to trial entry
• No evidence of ascites, pleural effusion or third space fluid accumulation
• Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy