Healthcare Industry News:  gene therapy  

Biopharmaceuticals Oncology Regulatory

 News Release - November 27, 2007

Gendux Announces Acceptance of Its ADVEXIN Marketing Authorization Application for Review by the EMEA

gene therapy Targeting Inherited Cancer is World's First

DUBLIN--(HSMN NewsFeed)--Gendux Molecular Limited (“Gendux”) announced today that its Marketing Authorization Application (“MAA”) for ADVEXIN® (“contusugene ladenovec”) has been accepted for technical review by the European medicines regulatory authority (the “EMEA”) for the treatment of an inherited cancer, Li-Fraumeni Syndrome (“LFS”). Gendux announced the submission of its MAA for ADVEXIN with the EMEA on 13th November 2007. ADVEXIN is the first treatment specific for an inherited cancer syndrome. ADVEXIN acts by reversing one of the most common cancer genetic defects, abnormal p53 tumor suppressor levels that are inherited in Li-Fraumeni patients and which are found in the majority of non-inherited cancers. ADVEXIN is also being developed for head and neck cancer and filings for this indication are anticipated before the end of 2007 both in Europe and the US.

The acceptance of the MAA for ADVEXIN will initiate the regulatory review of the Application’s preclinical, manufacturing and clinical data by the EMEA. Gendux is utilizing the Exceptional Circumstances Approval rules available in Europe 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, 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. An important aspect of ADVEXIN therapy is that patients’ tumors can be checked to determine if they have the p53 abnormality targeted by ADVEXIN using widely available diagnostic tests.

Dr. Max Talbott, senior vice president of Worldwide Regulatory Affairs, said, “The acceptance of our ADVEXIN application is a historic moment in the development of gene therapy. If approved, ADVEXIN will be the world’s first specific treatment for an inherited cancer syndrome and could represent a totally novel, personalized approach for a broad range of cancers. The EMEA’s response to our filing reflects both the regulatory quality of our Application and the EMEA’s readiness to begin the technical review. We look forward to our interactions with the EMEA and the opportunity of bringing this breakthrough treatment to the market as quickly as possible for the treatment of this devastating disorder.”


ADVEXIN p53 therapy is a targeted gene 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 defence, 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 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:

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:

Forward-Looking Statements

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: Gendux Molecular

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