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Patient Enrollment Initiated for Phase 3 Trial of BLP25 Liposome Vaccine in Stage 3 Non-Small Cell Lung Cancer

EDMONTON, Jan. 2 /PRNewswire-FirstCall/ -- Biomira Inc. (NASDAQ:BIOM) (TSX: BRA) today announced that the global Phase III clinical trial, START (Stimulating Targeted Antigenic Responses To NSCLC), assessing the efficacy and safety of Stimuvax(R) (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 of Darmstadt, Germany, ("Merck") and its U.S. affiliate EMD Pharmaceuticals, Inc. under the provision of a collaboration agreement between Biomira and Merck. Biomira is entitled to a milestone payment upon enrollment of the first patient in the Phase III trial, which is anticipated to occur in January 2007.

Enrollment in 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.

About the START Trial
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 (EMEA/CHMP) and has been agreed upon with the U.S. Food and Drug Administration (FDA) through a Special Protocol Assessment (SPA). Data from a randomized phase IIb trial described below encouraged the initiation of the Phase III program.

For more information on the START trial, or to find a participating center and eligibility criteria, log on to www.StimuvaxSTART.com or www.clinicaltrials.gov.

About Stimuvax
Stimuvax is an innovative 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.

A randomized Phase IIb trial was conducted in 171 patients with stage IIIb and IV NSCLC with response or stable disease after first line therapy. While the overall study results were not statistically significant, in the randomization stratum of patients with stage IIIb locoregional disease, Stimuvax showed a median survival of 30.6 months versus 13.3 months in the control group - an improvement of 17.3 months. In the Phase IIb trial, side effects were primarily limited to mild-to-moderate flu-like symptoms, GI disturbances, and mild injection site reactions.

Source: Biomira

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