17.07.2008 11:30:00
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Introgen to Present ADVEXIN Phase 3 Study Results at American Association for Cancer Research's Cancer Clinical Trials and Personalized Medicine Conference
Introgen Therapeutics, Inc. (NASDAQ:INGN), a developer of targeted
molecular therapies for cancer, today 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.
Details of the presentation are as follows:
Abstract Title: "Tumor p53 biomarkers
predict efficacy of ADVEXIN p53 therapy providing for personalized
treatment of patients with recurrent squamous cell carcinoma of the
head and neck”
Date: Tuesday, July 22, 2008
Time: 5:00-7:00 pm 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.
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