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Molecular Biomarkers Predicting Efficacy of Introgen Therapeutics' ADVEXIN Cancer Therapy Are Highlighted at Major Cancer Conference

Posted on: Friday, 15 September 2006, 09:01 CDT

CHICAGO, Sept. 15 /PRNewswire-FirstCall/ -- News of Introgen Therapeutics, Inc.'s 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: http://www.aacr.org/Default.aspx?p=1275&d=652 .

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."

About ADVEXIN

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 U.S. Food and Drug Administration (FDA). 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.

About AACR

AACR is the oldest and largest scientific organization in the world focused on every aspect of high-quality, innovative cancer research. Its reputation for scientific breadth and excellence attract the premier researchers in the field. The programs and services of AACR foster the exchange of knowledge and new ideas among scientists dedicated to cancer research, provide training opportunities for the next generation of cancer researchers, and increase public understanding of cancer.

About Introgen Therapeutics, Inc.

Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle tumor suppressor therapies to treat a wide range of cancers using tumor suppressors, cytokines and genes. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility.

Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to Introgen's future success with its research programs and clinical development program for treatment of cancer or other diseases and Introgen's financial performance. The actual results may differ from those described in this release due to risks and uncertainties that exist in Introgen's operations and business environment, including Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, dependence upon proprietary technology and the current competitive environment, history of operating losses and accumulated deficits, reliance on collaborative relationships, and uncertainties related to clinical trials, the safety and efficacy of Introgen's product candidates, the ability to obtain the appropriate regulatory approvals, Introgen's patent protection and market acceptance, as well as other risks detailed from time to time in Introgen's filings with the Securities and Exchange Commission, including its filings on Form 10-K and Form 10-Q. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising after the date hereof.

Editor's Note: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen's website at http://www.introgen.com/ .

Contact: Introgen Therapeutics, Inc. C. Channing Burke (512) 708 9310 Ext. 322 Email: c.burke@introgen.com

Introgen Therapeutics, Inc.

CONTACT: C. Channing Burke of Introgen Therapeutics, Inc.,+1-512-708 9310 Ext. 322, c.burke@introgen.com

Web site: http://www.introgen.com/http://www.aacr.org/Default.aspx?p=1275&d=652

Source: PRNewswire-FirstCall

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