Introgen Therapeutics Inc has received a Small Business Technology Transfer (STTR) grant from the National Cancer Institute to support a recently initiated Phase 2 clinical trial of INGN 241 in patients with malignant melanoma.

The grant will provide over $1.8 million in funding and will support a Phase 2 trial designed to evaluate the efficacy and biologic activity of INGN 241 in this indication. The grant also covers costs associated with the performance of assays to measure induction of tumor cell death and anti-tumor immune system activation in patients with metastatic melanoma.

The primary investigators on the grant are Elizabeth A. Grimm, Ph.D., Co-Director of the Melanoma Research Program and Professor, Department of Bioimmunotherapy at The University of Texas M.D. Anderson Cancer Center, and Sunil Chada, Ph.D., Introgen's director of research and development.

"This grant is a validation of the significant potential of INGN 241 as a novel treatment for malignant melanoma," said Dr. Chada. "Currently available treatment options for advanced disease are associated with serious side effects but have little impact on survival. Studies of INGN 241 in a variety of cancers indicate that this product candidate has favorable safety and tolerability profiles. Results from a previous clinical study testing INGN 241 in a variety of solid tumors, including malignant melanoma, have been very encouraging, with regression of multiple injected tumors. This grant will support continued development of INGN 241 in this indication, as melanoma is one with clear unmet medical need."

The grant will support a recently initiated Phase 2 trial, which is designed to enroll up to 25 patients with metastatic melanoma. The primary objective of this study is to determine if intratumoral injection of INGN 241 can exert regional and systemic biologic activity. Secondary objectives include toxicity, tumor response and induction of specific immunity against the patients' melanoma cells. The study is being conducted at The University of Texas M. D. Anderson Cancer Center.

"An important component of this grant is funding to evaluate induction of tumor cell death and stimulation of systemic anti-tumor immune system responses in patients with malignant melanoma following administration of INGN 241," said Dr. Grimm. "These studies may help to expand our knowledge of the molecular basis of malignant melanoma and also may enhance our understanding of some of the multiple anti-cancer activities of MDA-7/IL-24, the active component of INGN 241."