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Biotech / Medical : Introgen Therapeutics -- Ignore unavailable to you. Want to Upgrade?

To: tnsaf who wrote (569)	9/15/2006 3:09:25 PM
From: Jibacoa	Read Replies (1) \| Respond to of 802

And more or less the same news: Molecular Biomarkers Predicting Efficacy of Introgen Therapeutics' ADVEXIN Cancer Therapy are Highlighted at Major Cancer Conference Friday September 15, 7:00 am ET Agreement with FDA for Analyses Using Biomarkers Supports ADVEXIN Approval CHICAGO, Sept. 15 /PRNewswire-FirstCall/ -- News of Introgen Therapeutics, Inc.'s (Nasdaq: INGN - News) use of a molecular biomarker to predict the efficacy of its ADVEXIN cancer therapy was released yesterday by the American Association for Cancer Research (AACR). Introgen has reached agreement with the U.S. 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 AACR news release is entitled, "Abnormal Overexpression of p53 is a Predictive Molecular Biomarker of Advexin Efficacy in Recurrent Squamous Cell Carcinoma of the Head and Neck" and can be found at: aacr.org . 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." Snip Bernard