Ph I/II dosing with GenVec's TNFerade

US biopharmaceutical firm GenVec says that the first patient has been dosed in a Phase I/II trial with its adenovector TNFerade for head and neck cancer at the University of Chicago Medical Center. The firm is sponsoring two separate Phase I/II studies at the University of Chicago to explore the use of TNFerade as a second-line treatment for unresectable, recurrent tumors, and as a first-line treatment for elderly or frail patients. The research is being funded by the National Cancer Institute.

The two separate trials, which will be led by principal investigators Everett Vokes, and Tanguy Seiwert,could enroll up to 70 patients with unresectable, recurrent tumors and up to 60 elderly or frail subjects with new onset, locally-advanced disease. The investigators will first determine best dose in each indication, and will assess safety and locoregional control of the cancer following TNFerade treatment as a component of standard of care.

Mark Thornton, GenVec's senior vice president of product development, commented: "we know that local control is crucial for effective treatment of head and neck cancers, and is a respected regulatory endpoint. Since TNFerade is administered directly at the tumor site, it is ideally suited for these specific indications. TNFerade also has a well-established safety profile, so we believe it is a potentially appropriate treatment for elderly or frail cancer patients who cannot tolerate the cytotoxic effects of systemically administered cancer therapies."