Viventia Biotech has received clearance from Health Canada to initiate a Phase II study evaluating Proxinium for the treatment of patients with chemotherapy-refractory recurrent head and neck cancer.
"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 Viventia's Dr. Nick Glover.
Viventia recently announced it had been cleared by the FDA to initiate a Phase II trial of Proxinium for chemotherapy-refractory recurrent head and neck cancer.
Proxinium combines a cytotoxic protein payload with the precise tumor-targeting characteristics of a monoclonal antibody.
A single molecule of the cytotoxic protein payload, Pseudomonas exotoxin, is capable of eliminating 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.
Proxinium has been designated an Orphan Drug for the treatment of head and neck cancer in the U.S. and EU. Head and neck cancer is the 9th most common cancer in North America, with approximately 55,000 new cases diagnosed annually in the U.S. alone. Head and neck cancer recurs in 60 - 70% of patients.
Viventia Biotech develops powerful and precise anti-cancer drugs.
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