GenVec Inc. has initiated a Phase II clinical study to evaluate the anti-cancer activity of TNFerade in patients with metastatic melanoma.
The study will assess tumor response after four weeks of intratumoral injections of TNFerade plus simultaneous radiation therapy in 29 patients with stage III or IV metastatic melanoma who are ineligible for surgery or unlikely to benefit from other treatment options.
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 anti-cancer effects, for direct injection into tumors. Following injection, TNFerade stimulates TNF-alpha production in the tumor. The company is developing TNFerade for use in conjunction with radiation and/or chemotherapy for the treatment of a variety of cancers.
In Phase I of the study in patients with solid tumors, three patients with stage IV metastatic melanoma had complete local response and prolonged disease-free survival after a local TNFerade lesion injection in combination with radiation. Two of those patients remain disease-free four years after treatment, compared with the average survival rate of two years for patients with stage IV metastatic melanoma.
“This study expands the TNFerade development program into a potential indication where there is a significant medical need,” Thomas Davis, M.D., chief medical officer of GenVec, said in a statement. “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.”
GenVec Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines.
