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Article: Biomira and Merck KGaA Announce Phase III Theratope(R) Vaccine Trial Does Not Meet Primary Endpoints; Trend to Improvement in Survival Seen in Subset of Patients.
- Article from:
- PR Newswire
- Article date:
- June 17, 2003
CopyrightCOPYRIGHT 2003 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Biomira Inc. (TSX:BRA) and Merck KGaA of Darmstadt, Germany, announced today that the results from a large pivotal Phase III trial of Theratope(R) 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 pre-stratified subset of patients in the treatment group, women on hormonal treatment following chemotherapy, appeared to show a favourable 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 Companies ...