Healthcare Industry News: Head and Neck Cancer
News Release - November 27, 2007
Introgen's ADVEXIN Advances as Marketing Authorization Application is Accepted for Review in EuropeAUSTIN, Texas--(HSMN NewsFeed)--Introgen Therapeutics, Inc. (NASDAQ:INGN ) and its subsidiary, Gendux Molecular Limited (“Gendux”), announced today the advancement of a Marketing Authorization Application (“MAA”) for ADVEXIN. The MAA, the submission of which was recently announced, has now been accepted for technical review by the European medicines regulatory authority (the “EMEA”) for the treatment of inherited Li-Fraumeni Syndrome (“LFS”) cancers. This acceptance indicates that all administrative issues have been addressed and that the formal technical evaluation of the Application will be conducted under the EMEA’s Exceptional Circumstances Approval rules. If approved, ADVEXIN would be the world’s first treatment specific for an inherited cancer syndrome. ADVEXIN is targeted to reverse one of the most common cancer genetic defects that is inherited in Li-Fraumeni patients and found in the majority of non-inherited cancers.
The acceptance of the MAA for ADVEXIN will initiate the regulatory review of the Application’s preclinical, manufacturing and clinical data by EMEA. Exceptional Circumstances Approval rules available in Europe are being utilized by Gendux to expedite review of potential breakthrough therapies. The review will be based on clinical efficacy and safety results from the use of ADVEXIN in LFS and in a wide variety of non-inherited cancers with abnormal p53 tumor suppression that is the target of ADVEXIN treatment. Abnormal p53 is inherited in LFS and is also the most commonly identified defective gene in all solid cancers whether inherited or acquired. Patients’ tumors can be checked to determine if they have the p53 abnormality targeted by ADVEXIN using widely available tests.
Dr. Max Talbott, senior vice president of Worldwide Regulatory Affairs, said, “The ADVEXIN application is a historic submission, and could represent a truly personalized cancer therapy approach. We are encouraged by the EMEA’s acceptance of our Application under the Exceptional Circumstances Approval provisions and now look forward to working with the European regulatory authorities during the technical review process.”
ADVEXIN p53 therapy 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 tumor growth control in recurrent Head and Neck Cancer, lung cancer, breast cancer, esophageal, prostate and other cancer indications. ADVEXIN has demonstrated clinical activity in a number of solid tumor types in multiple phase 1, 2 and 3 clinical trials conducted worldwide.
About Li-Fraumeni Syndrome
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, cancer patients can lose the ability to naturally combat cancer. Without a normally functioning p53 defense, LFS cancer patients often develop spontaneous and widespread tumors at an early age. Frequently, multiple members of the same family suffer from this genetic disorder and currently there are no approved therapies to specifically treat LFS.
About Introgen Therapeutics, Inc.
Introgen (NASDAQ:INGN ) 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. Introgen 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. For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen’s Website at: www.introgen.com.
About Gendux Molecular Limited
Gendux Molecular Limited is a non-resident Irish company based in Dublin, Ireland. The Company is focused on the commercialization of targeted molecular therapies to be applied with molecular diagnostic tools to introduce personalized medical products in European and other markets. Gendux is a subsidiary of Introgen Therapeutics, Inc. For more information on Gendux, or for a menu of archived press releases, please visit Gendux’s Website at: www.gendux.ie.
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 LFS cancers, the approval of ADVEXIN for LFS in European markets, and the acceptance of 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.
Source: Introgen Therapeutics
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