Healthcare Industry News: p53
News Release - May 8, 2006
Introgen's ADVEXIN p53 Therapy Provided to Cancer Patients With Li-Fraumeni SyndromeADVEXIN Available on Compassionate Use Basis to Qualified Patients
AUSTIN, Texas, May 8 (HSMN NewsFeed) -- Introgen Therapeutics' (Nasdaq: INGN ) ADVEXIN p53 therapy has been successfully used to treat a Li-Fraumeni Syndrome cancer patient on a compassionate use basis under a protocol authorized by the U.S. Food and Drug Administration. Based upon the encouraging clinical findings, Introgen will make ADVEXIN p53 therapy available on a compassionate use basis to qualified Li-Fraumeni Syndrome patients with tumors refractory to standard treatment through protocols at qualifying institutions.
About Li-Fraumeni Syndrome
Li-Fraumeni Syndrome (LFS) is an 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 represents therapy targeted to the molecular defect underlying the cause and progression of these cancers.
Robert E. Sobol, M.D., Introgen's senior vice president of Clinical and Scientific Affairs said, "ADVEXIN treatment of tumors resulting from this Syndrome represents the epitome of targeted therapy as the cause of these cancers is due to abnormal p53 function that is directly addressed by ADVEXIN treatment."
Requirements for participation in this program may be obtained by contacting Introgen at its toll-free Clinical Trials hotline at 866-631-4646.
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 and to safely enhance the anti-cancer effects of radiation and chemotherapy treatments.
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 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 FDA. 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: http://www.introgen.com .
Source: Introgen Therapeutics
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