Healthcare Industry News:  p53 

Biopharmaceuticals Oncology Regulatory

 News Release - May 9, 2006

Gendux AB and Introgen Therapeutics File European Orphan Drug Designation for ADVEXIN

STOCKHOLM, Sweden and AUSTIN, Texas, May 9 (HSMN NewsFeed) -- Gendux AB and Introgen Therapeutics, Inc. (Nasdaq: INGN ) announced today that Gendux AB has submitted an Orphan Drug Designation Request to the European Medicines Evaluation Agency (EMEA) for the use of ADVEXIN p53 therapy in the treatment of cancer patients with Li-Fraumeni Syndrome. Gendux is a wholly owned subsidiary of Introgen Therapeutics, Inc.

Commenting on the use of ADVEXIN in Li-Fraumeni Syndrome, Max Talbott, Ph.D., senior vice president of Worldwide Commercialization at both Gendux and Introgen, said, "Based upon discussions with EMEA and encouraging clinical data, Gendux has filed the Orphan Drug Designation Request in Europe. We intend to provide ADVEXIN on a compassionate use basis to qualifying patients in Europe as well as other countries including the United States. I applaud the European regulators who have established expedited procedures designed to speed the development and approval of therapies for orphan diseases such as Li-Fraumeni Syndrome. We believe we can provide real medical benefit for those suffering from this devastating disease."

Under EMEA rules, treatments for orphan diseases such as Li-Fraumeni may be approved under "Exceptional Circumstance" provisions. A Marketing Authorization Application filed under these provisions can be reviewed on an expedited basis. This registration approach is more streamlined than EMEA's Conditional Approval procedures. The Conditional Approval procedures are very similar to the U.S. FDA's Accelerated Approval regulations.

Robert E. Sobol, M.D., senior vice president of Clinical and Scientific Affairs said, "Cancers resulting from this syndrome are due to abnormal p53 function that is directly addressed by ADVEXIN's mechanisms of action and is the epitome of targeted molecular therapy."

About Li-Fraumeni Syndrome

Li-Fraumeni Syndrome (LFS) is a rare inherited genetic disorder that greatly increases the risk of developing several types of cancer typically with initial occurrence at a young age. The majority of LFS families have inherited mutations in the p53 tumor suppressor gene. The treatment of Li- Fraumeni tumors with ADVEXIN p53 therapy targets the molecular defect underlying the cause and progression of these cancers.


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 supplies p53 protein in very high concentrations in cancer tissue and selectively kills cancer cells. p53, known as the "Guardian of the Genome," is a normal constituent of cells and is known as a tumor suppressor because it inhibits the growth of tumor cells. One of the major roles of this protein is to eliminate cancerous cells by recognizing when the cell has been damaged by mutations and stopping cell growth to initiate repair. If the cell is damaged beyond repair, p53 initiates the cell death pathway to prevent the cell from growing out of control.

ADVEXIN has been evaluated in a variety of cancer types and in combination with several standard cancer therapies, including radiation and chemotherapy. Data from several published preclinical and clinical studies have demonstrated the activity of ADVEXIN as a monotherapy. In addition, these data have also shown ADVEXIN to safely enhance the anti-cancer effects of radiation, chemotherapy, and biological treatments.

About Gendux AB

Gendux AB is engaged in the development and commercialization of targeted, molecular medicines for European markets. Gendux uses therapeutic genes and other agents in a variety of nano-scale delivery systems to treat disease at the molecular and cellular level. Gendux is developing less toxic, novel biopharmaceutical products to address unmet medical needs. Gendux AB is a wholly owned subsidiary of Introgen Therapeutics, Inc. (Nasdaq: INGN ), a leader in the field of molecular oncology. Gendux is based in Stockholm, Sweden with additional offices in London UK.

About Introgen Therapeutics, Inc.

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 tumor suppressor therapies to treat a wide range of cancers using tumor suppressors, cytokines and genes. 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 the designation of ADVEXIN as an Orphan Drug for Li-Fraumeni Syndrome and those relating to Introgen's future success with its ADVEXIN clinical development program for the treatment of cancer patients with Li-Fraumeni Syndrome. ADVEXIN p53 therapy is investigational and has not been approved by the EMEA. The safety and efficacy of ADVEXIN p53 therapy for the treatment of LFS has not been established in clinical trials. Introgen may modify the participation criteria or stop making ADVEXIN p53 therapy available on a compassionate use basis in the future without notice at its sole discretion. There is no guarantee that any patient will be able to receive ADVEXIN p53 therapy on a compassionate use basis. 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: For more information on the Li-Fraumeni Syndrome program, please visit the Ongoing Clinical Trials section of Introgen's Website.

Editor's Note: For more information on Gendux, please visit its Website at

Source: Introgen Therapeutics

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