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news.Viventia Biotech has received clearance from Health Canada to initiate a phase II study evaluating its drug Proxinium for the treatment of patients with chemotherapy-refractory recurrent head and neck cancer.
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Proxinium combines a powerful cytotoxic protein payload with the highly precise tumour-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 & neck cancer, ensuring that the payload is delivered directly to the tumour.
“This clearance will allow us to expand our proposed phase II trial for Proxinium to include Canadian patients and reflects our strategy to ultimately develop Proxinium on a global basis,” said Dr Nick Glover, Viventia’s president and CEO.
Viventia recently announced it had been cleared by the FDA to initiate a phase II trial of Proxinium in the United States. The company anticipates initiating the trial by the end of 2005. Proxinium has been designated an orphan drug for the treatment of head and neck cancer in the US and EU.