Introgen To Present ADVEXIN Phase 3 Study Results At American Association For Cancer Research's Cancer Clinical Trials

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 21 Jul 2008 - 2:00 PDT

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Introgen Therapeutics, Inc. (NASDAQ:INGN), a developer of targeted molecular therapies for cancer, announced that the company will present the results from its recently completed Phase 3 trial of ADVEXIN in recurrent head and neck cancer at the American Association for Cancer Research (AACR) Centennial Conference on Translational Cancer Medicine 2008: Cancer Clinical Trials and Personalized Medicine. The conference will be held July 20-23, 2008 at the Hyatt Regency Monterey in Monterey, CA.

Introgen's presentation will review the previously announced findings from the Company's Phase 3 trial which demonstrated that ADVEXIN successfully achieved its primary and secondary efficacy endpoints in the study's pre-specified p53 biomarker population. In addition, Introgen will present supplemental statistical analyses that are included in the Company's Biologics License Application and Marketing Authorization Application in the U.S. and Europe, respectively.

About ADVEXIN

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 efficacy can be predicted with the use of tumor p53 profiles (biomarkers) using readily available diagnostic tests prior to treatment. ADVEXIN has demonstrated increased survival and tumor growth control in recurrent head and neck cancer patients. ADVEXIN has demonstrated clinical activity in a number of solid tumor types in multiple Phase I, II and III clinical trials conducted worldwide. ADVEXIN is considered an 'Orphan Drug' in the U.S. for the treatment of recurrent, refractory head and neck cancer, which, if approved, entitles the drug to extended market exclusivity for the approved indication. ADVEXIN is a registered trademark describing p53 therapy, developed by Introgen under exclusive worldwide licenses from The University of Texas M.D. Anderson Cancer Center.

About Introgen

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.

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 programs for treatment of cancer and the use of biomarker data to support the regulatory approval of ADVEXIN and improve the care of patients. 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. Only the FDA, EMEA and corresponding regulatory agencies have the authority to approve pharmaceutical products.

Introgen
http://www.introgen.com