Molecular biomarkers predicting efficacy of cancer therapy highlighted.

Introgen Therapeutics, Inc.'s use of a molecular biomarker to predict the efficacy of its ADVEXIN cancer therapy was discussed at the American Association for Cancer Research (AACR) international conference. Introgen has reached agreement with the United States Food and Drug Administration (FDA)

to incorporate the use of Introgen's p53 molecular biomarkers in the analysis of ADVEXIN clinical data used in support of FDA submissions for approval. Data were presented at the AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development in Chicago.

The data demonstrate that a simple test may be used to identify patients showing statistically significant increased survival and disease control following ADVEXIN therapy. Importantly, pre-treatment analysis could be used to identify patients who are most likely to respond to ADVEXIN and least likely to benefit from conventional cancer therapies. The same molecular biomarker may also be used to identify cancer patients lacking normal cancer suppression function.

Max Talbott, Introgen's senior vice president of Worldwide Commercial Development and Regulatory Affairs stated, "The use of Introgen's prognostic biomarkers for clinical data analysis are important in positioning ADVEXIN therapy for FDA approval and wide clinical application. We plan to use the biomarkers to analyze our Phase 3 patient data and are exploring the use of ADVEXIN as a potential therapy for any solid tumors in patients characterized by abnormal p53 protein levels. We are encouraged that our biomarkers may also be employed to identify patients that could avoid toxicities associated with conventional cancer treatments."

ADVEXIN is a targeted molecular therapy with broad applicability in a wide range of tumor types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumor suppressor function, associated with cancer initiation, progression and treatment resistance. ADVEXIN has demonstrated increased survival and durable locoregional disease control in recurrent head and neck cancer patients. Prognostic biomarkers can identify patients most likely to respond to ADVEXIN. ADVEXIN has demonstrated clinical activity in a number of solid tumor types in multiple phase 1, 2 and 3 clinical trials conducted worldwide. A request for accelerated approval for ADVEXIN is now pending at the United States Food and Drug Administration. The FDA has selected ADVEXIN as a fast track program for an unmet medical need and has designated ADVEXIN for orphan drug use for recurrent head and neck cancer.