Healthcare Industry News: p53
News Release - November 13, 2007
Introgen and Gendux Submit First Marketing Authorization Application for ADVEXINSubmission to European Medicines Regulatory Agency Targets Li-Fraumeni Syndrome Cancers
DUBLIN, Ireland & AUSTIN, Texas--(HSMN NewsFeed)--Introgen Therapeutics, Inc. (NASDAQ:INGN ) and its subsidiary, Gendux Molecular Limited (“GML”), today announced that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) for ADVEXIN®, a targeted p53 tumor suppressor therapy for the treatment of Li-Fraumeni Syndrome cancers (LFS).
LFS is a cancer syndrome characterized by the inheritance of an abnormal p53 tumor suppressor. 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 and there are no approved therapies to specifically treat LFS.
The Company submitted the MAA under the EMEA’s Exceptional Circumstances Approval rules for breakthrough therapies for rare diseases such as LFS. Therefore, approval, if granted, will be based on clinical results from the use of ADVEXIN in LFS, a designated orphan indication for the drug in Europe, and also from results of other trials with ADVEXIN in a wide variety of non-inherited solid tumors that share the p53 biomarker abnormality, which characterizes LFS.
“The submission is an important milestone achievement for the company in the development of ADVEXIN,” said Dr. Max W. Talbott, Introgen’s senior vice president of Worldwide Regulatory Affairs. “This announcement is the first of multiple anticipated registration submissions for Introgen. We are also on track to make two additional ADVEXIN submissions in 2007, one in the U.S. and one in Europe, for recurrent head and neck cancer.”
ADVEXIN is a targeted molecular therapy with the potential to be broadly applicable across 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 tumor growth control in recurrent head and neck cancer.
About Introgen Therapeutics, Inc. and Gendux Molecular Limited
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®, 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. GML, a subsidiary of Introgen, is engaged in the development and commercialization of targeted, molecular medicines for European markets.
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 Li-Fraumeni Syndrome cancers and the acceptance of Introgen and Gendux Molecular Limited’s Marketing Authorization Application. 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. For more information on Gendux, please visit the Website at www.gendux.com.
Source: Introgen Therapeutics
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