The randomized, open-label trial tested the clinical potential of the drug in patients with stage IIIB and IV non-small cell lung cancer (NSCLC). The analysis confirms a median survival in stage IIIB patients on vaccine being 30.6 months, while stage IIIB patients on the control had a median survival of 13.3 months.
“These data from the phase IIb trial are encouraging,” commented Dr Alex McPherson, president and CEO of Biomira. “We are in the process of completing the transition of this exciting project to Merck KGaA of Darmstadt, Germany and we have begun manufacturing the vaccine required for the phase III study slated to start this summer. We are hopeful that this larger randomized trial will confirm the results seen in the phase IIb trial.”
Stimuvax, designed to induce an immune response to cancer cells, incorporates a 25-amino acid sequence of the MUC1 cancer mucin, encapsulated in a liposomal delivery system. The liposome enhances recognition of the cancer antigen by the immune system and facilitates better delivery.