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Metastatic breast cancer vaccine trial to continue.(Brief Article)

Vaccine Weekly

| November 27, 2002 | COPYRIGHT 2002 NewsRX. 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)Copyright

2002 NOV 27 - (NewsRx.com & NewsRx.net) -- Biomira, Inc., (BIOM), of Edmonton, Alberta, Canada, and Merck KGaA of Darmstadt, Germany, announced that they will continue their phase III clinical trial of Theratope vaccine through its planned conclusion in 2003.

This decision was made based on a recommendation from an independent review of interim data from their double-blinded randomized trial conducted in 1030 women with metastatic breast cancer. Theratope vaccine has fast-track designation with the U.S. Food and Drug Administration (FDA) for the treatment of metastatic breast cancer.

The Data Safety Monitoring board (DSMB) stated that they had "no safety concerns at all and recommend that the trial continue to final analysis." The DSMB also said they had "no safety concerns with continuing the present programs or initiating new trials under the current development plan."

Biomira and Merck KGaA, which are collaborating on the development of Theratope vaccine, reached this decision after the DSMB, an independent panel of cancer trial ...

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