Industry News/Diagnostics

Clinical Trial of Imaging Agent in Cancer Recurrence Cleared

Published in Women's Health Weekly, August 14th, 1995

Biomira Inc., Edmonton, Alberta, Canada, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase II/III clinical trial to support a Product License Application (PLA) for the Tru-Scint AD monoclonal antibody kit for the detection of recurrent breast cancer.

The multi-centre, U.S. Phase II/III clinical trial will involve 150 evaluable patients and full patient enrollment should take approximately one year.

The company made the decision to initiate the Phase II/III clinical trial based upon a review of the data from the Phase II Canadian and German clinical trials, where the Tru-Scint AD kit was...

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Source: Women's Health Weekly (1995-08-14)

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