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Phase III clinical trials NSCLC vaccine due this year


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Vaccine trial for non-small cell lung cancerSource: (Biomira press release)

Wednesday, September 14, 2005

EDMONTON, Canada – Sept. 14, 2005 – Biomira Inc., today announced that it has completed the enrollment of a 20-patient phase II study of its non-small cell lung cancer vaccine.

The phase II trial assesses the safety of the liposome formulation of its L-BLP25 vaccine that Biomira and partner Merck KGaA, Germany plan to use in an upcoming large random comparison trial to determine the effectiveness of the vaccine. The phase III study design is currently under discussion with the FDA. The formulation incorporates manufacturing changes intended to secure the future commercial supply of the vaccine.

After 23 months an early analysis of a subset of men and women who received L-BLP25 with stage IIIB non-small cell lung cancer that could not be treated with surgery they found that the survival median had not been reached. This means more patients have survived than died and a midpoint of half having survived and half having died had not been reached for statistical analysis. Initial results from the 20-patient trial are anticipated before the end of 2005.

"The completion of enrollment for this phase II safety study is another important step toward commencing our large, multi-national phase III study, which we expect to begin by the end of this year," said Dr. Alex McPherson, president and CEO.

The cancer vaccine is thought to work by mimicking a protein called MUC1 displayed in a deformed manner on the surface of tumor cells. The BLP25 vaccine injected into the skin is then taken into the lymph system where the body's defender T cells learn to recognize the deformed protein. The T cells then bind to the deformed MUC1 proteins on the tumor cells and destroys them.

The biotechnology company is developing the vaccine in collaboration with Merck KGaA, Germany.

In 2004, approximately 174,000 new cases of lung were diagnosed in the U.S. Approximately 160,000 people are estimated to have died of this disease in the U.S. alone in 2004. NSCLC accounts for approximately 75 to 80 percent of all primary lung cancers. At the time of diagnosis, only 25 per cent of patients are potentially curable by surgery.

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