GENVEC INITIATES STUDY OF TREATMENT FOR HEAD AND NECK CANCER

GenVec announced that the first patient has been dosed in a Phase I/II trial of TNFerade for head and neck cancer. GenVec is sponsoring two separate Phase I/II studies 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 trials are being funded by the NIH's National Cancer Institute.

The two separate trials could enroll up to 70 patients with unresectable, recurrent tumors and up to 60 elderly or frail patients with new-onset, locally advanced disease. The investigators will first determine the 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.

"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," Mark Thornton, GenVec's senior vice president of product development, said.

TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor alpha (TNF (alpha)), an immune system protein with potent and well-documented anticancer effects. After administration, TNFerade stimulates the production of TNF (alpha) in the tumor.