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www.fdanews.com/articles/81041-viventia-receives-fda-clearance-to-initiate-trial-for-proxinium

VIVENTIA RECEIVES FDA CLEARANCE TO INITIATE TRIAL FOR PROXINIUM

September 20, 2005

Viventia Biotech has received clearance from the FDA to begin a Phase II study evaluating Proxinium for the treatment of patients with chemotherapy-refractory recurrent head and neck cancer.

Proxinium combines a powerful cytotoxic protein payload with the highly precise tumor-targeting characteristics of a monoclonal antibody. A single molecule of the cytotoxic protein payload, Pseudomonas exotoxin, is capable of killing a cancer cell. The antibody fragment of Proxinium targets EpCAM - an antigen that is highly expressed on many epithelial cancers including head and neck cancer, ensuring that the payload is delivered directly to the tumor.