GenVec Begins Phase II Melanoma Study with TNFerade(TM)
Wednesday March 29, 7:00 am ET
GAITHERSBURG, Md.--(BUSINESS WIRE)--March 29, 2006--GenVec, Inc. (Nasdaq:GNVC - News) has begun a Phase II clinical study to evaluate the anticancer activity of TNFerade(TM) in patients with metastatic melanoma. The open-label, single-arm, multi-center study will assess tumor response after four weeks of intratumoral injections of TNFerade(TM) plus concomitant radiation therapy in 29 patients with stage III or IV metastatic melanoma who are ineligible for curative surgery or unlikely to benefit from other treatment options. Patients will be evaluated two months after the completion of therapy and followed for three years thereafter.
"This study expands the TNFerade(TM) development program into a potential indication where there is a significant medical need," said Thomas Davis, M.D., chief medical officer of GenVec. "This is an important study as it also provides a good clinical setting for us to test whether TNFerade(TM) can induce the body's immune system to fight systemic cancer."
In a Phase I trial in patients with solid tumors, three patients with stage IV metastatic melanoma had complete local response and prolonged disease-free survival after local TNFerade(TM) lesion injection plus concomitant radiation; two of those patients remain disease-free approximately four years after treatment. This compares to the average survival rate of less than 2 years for patients with stage IV metastatic melanoma. Previous studies have demonstrated the ability of TNFerade(TM) to suppress the metastasis of melanoma into the lymph nodes in an animal model (see GenVec press release dated April 20, 2005). GenVec recently announced the expansion of its ongoing Phase II study of TNFerade(TM) in patients with locally advanced pancreatic cancer into a 330 patient Phase II/III clinical trial.
TNFerade(TM) 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 anti-cancer effects, for direct injection into tumors. After administration, TNFerade(TM) stimulates the production of TNF-alpha in the tumor. GenVec is developing TNFerade(TM) for use in combination with radiation and/or chemotherapy for the treatment of various cancers. |
