Viventia Biotech's lead drug, Proxinium (formerly known as VB4-845), will be fast-tracked by the US Food and Drug Administration (FDA) in the treatment of patients with recurrent head and neck cancer, potentially cutting its review time down to six months from 10.
Proxinium combines a monoclonal antibody - targeting an antigen expressed on squamous cell carcinomas of the head and neck (SCCHN) - with a cell-killing toxin (Pseudomonas exotoxin). It is due to start Phase II trials in the USA and Canada before the end of the year.
"Recurrent, refractory head and neck cancer is a devastating and aggressive disease for which there are limited treatment options," said Dr Nick Glover, Viventia’s president and CEO. Head and neck cancer is the ninth most common cancer in North America, with approximately 55,000 new cases diagnosed annually in the US alone, leading to 14,000 deaths annually. Head and neck cancer recurs in 60% to 70% of patients.
Proxinium has orphan drug status in both the USA and European Union.