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Stimuvax(R) Phase II data highlight three-year survival results for patients with non-small cell lung cancer
Date:9/5/2007

ults, Stimuvax has entered its Phase III development and the START (Stimulating Targeted Antigenic Responses to NSCLC) trial is currently open for enrollment. The START trial is being conducted by Merck KGaA of Darmstadt, Germany, which has licensed worldwide development and commercialization rights to Stimuvax from Biomira. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Inc.

"Patients with unresectable stage III non-small cell lung cancer have significant unmet medical need, and the START study is the first Phase III program to evaluate a therapeutic cancer vaccine in this population," said Dr. Robert L. Kirkman, MD, President and Chief Executive Officer of Biomira. "If these survival results are statistically confirmed in the Phase III trial, Stimuvax has the potential to become an important tool in the treatment of lung cancer."

According to the American Cancer Society, lung cancer is the leading cause of cancer-related deaths in both men and women worldwide, with approximately 80% of cases classified as NSCLC. Current survival rates for NSCLC are low, with only 16% of patients alive five years post-diagnosis. Unfortunately for most patients, current treatments provide limited success. Stimuvax is an innovative cancer vaccine designed to stimulate the body's immune system to identify and destroy cancer cells expressing MUC1, a protein antigen that is widely expressed on common cancers including lung, breast and colorectal.

About the Phase II Trial

171 patients with ECOG 0-2 stage IIIB/IV NSCLC with stable or responding disease after any first-line chemotherapy with or without radiotherapy were randomized to receive Stimuvax plus BSC or BSC alone. Patients were stratified by stage of disease (IIIB LR or stage IIIB with malignant pleural effusion, and stage IV). Patients in the Stimuvax arm received a single intravenous dose of cyclophosphamide 300mg/m2 followed by 8 weekly subcutane
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SOURCE Biomira Inc.
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