GenVec begins phase 2 melanoma study with TNFerade

By E. Janene Geiss

Philadelphia, March 29 - GenVec, Inc. has begun a phase 2 clinical study to evaluate the anticancer activity of TNFerade 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 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, according to a company news release.

Patients will be evaluated two months after the completion of therapy and followed for three years thereafter.

"This study expands the TNFerade development program into a potential indication where there is a significant medical need," Thomas Davis, chief medical officer of GenVec, said in the release. "This is an important study as it also provides a good clinical setting for us to test whether TNFerade can induce the body's immune system to fight systemic cancer."

In a phase 1 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 lesion injection plus concomitant radiation; two of those patients remain disease-free four years after treatment, officials said. 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 to suppress the metastasis of melanoma into the lymph nodes in an animal model.

GenVec also recently announced the expansion of its ongoing phase 2 study of TNFerade in patients with locally advanced pancreatic cancer into a 330 patient phase 2/3 clinical trial.

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, for direct injection into tumors.

GenVec is a Gaithersburg, Md., biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines.

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