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Breast Cancer

Phase III Theratope vaccine trial does not meet primary endpoints

Published in Women's Health Weekly, July 17th, 2003

Biomira, Inc., (BIOM) (BRA) and Merck KGaA of Darmstadt, Germany, announced that the results from a large pivotal phase III trial of Theratope vaccine for women with metastatic breast cancer did not meet the two pre-determined statistical endpoints of time to disease progression and overall survival.

However, one prestratified subset of patients in the treatment group, women on hormonal treatment following chemotherapy, appeared to show a favorable trend to improvement in survival. Further analysis of this subset of patients is underway, as is additional analyses of the complete trial data.

Following this further analysis of the subset data, the...

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