Introgen Therapeutics Highlights Summary Advexin Data at the Third International Workshop on Mutant p53 and the Symposium on Li-Fraumeni SyndromeLYON, France--(BUSINESS WIRE)--Nov 15, 2007 - Introgen Therapeutics, Inc. (NASDAQ:INGN) today reported summary data from clinical studies of its lead product, ADVEXIN(R). These data confirm and extend previous biomarker data correlating the abnormal p53 biomarker with increased tumor responses following ADVEXIN treatment and support its use as a biomarker to predict ADVEXIN efficacy. Additionally, data are being presented demonstrating clinical benefit of ADVEXIN in a patient with a rare inherited form of cancer known as Li-Fraumeni Syndrome (LFS), a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene. These data have been the subject of previous presentations at scientific and medical conferences.
These data are being presented at the 3rd International Workshop on Mutant p53 and the Symposium on Li-Fraumeni Syndrome in Lyon, France, organized by the International Agency for Research on Cancer and the European community. The conference focuses on the biological role of mutant p53 and its clinical impact, bringing together an international community of scientists and clinicians to discuss state-of-the-art approaches to cancers in which p53 plays a role.
LFS is a cancer syndrome characterized by the inheritance of an abnormal p53 tumor suppressor. There are no approved therapies to specifically treat LFS. Normal p53, known as the "Guardian of the Genome," suppresses cancer and tumor formation. Without p53 tumor suppression, LFS patients often develop spontaneous and widespread tumors at an early age. Frequently, multiple members of the same family suffer from this genetic disorder.
Earlier this week, Introgen and its subsidiary, Gendux Molecular Limited, announced that a Marketing Authorization Application (MAA) was submitted to the European Medicines Agency for ADVEXIN, Introgen's targeted p53 tumor suppressor therapy for the treatment of Li-Fraumeni Syndrome cancers.
About Introgen Therapeutics, Inc.
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the development, manufacturing and commercialization of targeted tumor suppressors, a new class of therapies for the treatment of cancer. Introgen's technology delivers targeted molecular therapies that increase production of normal cancer-fighting proteins and cytokines. The Company is developing a proprietary pipeline of product candidates utilizing molecular biomarkers to identify patients most likely to benefit from its therapies which target central cancer-causing mechanisms. ADVEXIN(R), its lead product candidate, targets abnormal p53, a fundamental cancer defect present in over 50 percent of all tumors. Introgen is analyzing its phase 3 clinical trial for recurrent head and neck cancer using ADVEXIN as a monotherapy. The Company plans to complete regulatory filings in both the United States and in Europe by the end of 2007.
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 Li-Fraumeni syndrome cancers. 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.
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Posted: November 2007