The US Food and Drug Administration has designated Viventia Biotech Incs' lead drug, Proxinium, as a fast track product for the treatment of patients with recurrent squamous cell carcinoma of the head and neck (SCCHN).
The fast track programme facilitates the development and expedites the review of new therapeutics that are intended to treat serious or life threatening diseases and demonstrate the potential to address unmet medical needs. The fast track programme is intended to accelerate the filing of an NDA. The FDA will provide input into product development plans and may accept portions of the marketing application prior to the completion of the final registration package. Also most, but not all, drugs that are designated for the fast track programme are given priority review once the NDA is filed. The targeted date for drugs entitled to priority review is 6 months compared to the target of 10 months as set by the Food and Drug Modernisation Act, states a company release.
"Recurrent, refractory head and neck cancer is a devastating and aggressive disease for which there are limited treatment options. We look forward to working with the FDA to further advance our clinical strategy for Proxinium, which has shown promising early-stage efficacy results in patients with this form of cancer," said Dr. Nick Glover, president and CEO of Viventia.
Proxinium combines a powerful cytotoxic protein payload with the highly precise tumour-targeting characteristics of a monoclonal antibody. 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 tumour.
Viventia has been cleared by the FDA and Health Canada to initiate a Phase II trial of Proxinium for chemotherapy-refractory recurrent head and neck cancer. 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. Head and neck cancer is the 9th 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 - 70% of patients.
Viventia Biotech Inc is a biopharmaceutical company developing armed antibodies, powerful and precise anti-cancer drugs designed to overcome various forms of cancer.