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Introgen's ADVEXIN Clinical Biomarker Data Presented at Conference on Licensure of Cell and Gene Therapy Products

Posted on: Monday, 22 January 2007, 18:01 CST

Introgen Therapeutics Inc.'s (NASDAQ:INGN) reported today the application of regulatory biomarker initiatives to advance the global licensure of ADVEXIN by identifying patient populations most likely to benefit from this cancer treatment. These data were invited for presentation at an international cell and gene therapy conference and were reported by Dr. Robert E. Sobol, Introgen's senior vice president of Medical and Scientific Affairs, in a presentation titled "Critical Path and Oncology Biomarker Qualification Initiatives for the Late-Phase Development of ADVEXIN p53 Tumor Suppressor Therapy."

"We have previously reported that ADVEXIN therapy in recurrent head and neck cancer results in tumor responses and median survival that are comparable to the findings obtained with other more toxic therapies," stated Dr. Sobol. "Our biomarker data improves upon these results by identifying the patients most likely to benefit from ADVEXIN treatment with even greater increases in survival and tumor growth control."

Data were presented describing expanded p53 biomarker studies that show a highly significant correlation of abnormal p53 protein levels with increased survival of patients treated with ADVEXIN. The results demonstrate that recurrent head and neck cancer patients with the abnormal p53 biomarker were most likely to have a survival benefit from ADVEXIN p53 therapy and were the least likely to benefit from conventional treatment. Median survival of patients with tumors abnormally expressing p53 was 11.6 months compared to only 3.5 months in patients whose tumors did not have the p53 biomarker. Tumor disease control was observed in 75 percent of patients with the abnormal p53 biomarker compared to 18 percent of patients without the p53 biomarker. The statistical p values for these associations were highly significant: p = 0.0007 and p = 0.00063 for the survival and tumor response data respectively. These data were reviewed by the company last month during a conference call where the company described its plans to employ these biomarker analyses to advance ADVEXIN's licensure in the United States and Europe.

The Phacilitate Cell and Gene Therapy Forum is being held in Baltimore, Maryland, through January 24th and integrates regulatory, scientific and business topics with speakers from large pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration, the European Medicines Evaluation Agency and academic experts in cell and gene therapy.

Dr. Sobol will also moderate a session at the conference on clinical and regulatory considerations for the licensure of cell and gene therapy products. The panel includes regulatory agencies and biotechnology company representatives.

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 therapies to treat a wide range of cancers using tumor suppressors and cytokines. 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 ADVEXIN clinical development program for treatment of cancer and its plans to employ these biomarker analyses to advance ADVEXIN's licensure in the United States and Europe. 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: www.introgen.com.

Source: Business Wire

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