BIOMIRA BEGINS TRIAL OF STIMUVAX IN NSCLC

Biomira announced that its global Phase III clinical trial, START, assessing the efficacy and safety of Stimuvax (BLP25 liposome vaccine) as a potential treatment for patients with unresectable, stage III, non-small-cell lung cancer (NSCLC) is open for patient enrollment. The trial is being conducted by Merck KGaA and its U.S. affiliate EMD Pharmaceuticals under a collaboration agreement between Biomira and Merck KGaA. Biomira is entitled to a milestone payment upon enrollment of the first patient, which is anticipated this month.

The trial, which is expected to include more than 1,300 patients in approximately 30 countries, is now open to patients in 12 countries, including the U.S., and will subsequently expand to additional countries. Currently, there are no approved maintenance therapies for patients responding to first-line treatment for unresectable, stage III, NSCLC.

The START trial is a randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable, stage III, NSCLC who have had a response or stable disease after at least two cycles of platinum based radio-chemotherapy. The study has been designed considering scientific advice from the European Medicines Agency and has been agreed upon with the FDA through a Special Protocol Assessment.

Stimuvax is a cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers. MUC1 is over expressed on many cancers such as lung cancer, breast cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1.