Introgen and Gendux Submit First Marketing Authorization Application for ADVEXIN
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Introgen Therapeutics, Inc. (NASDAQ:INGN) and its subsidiary, Gendux
Molecular Limited ("GML”),
today announced that a Marketing Authorization Application (MAA) has
been submitted to the European Medicines Agency (EMEA) for ADVEXIN®,
a targeted p53 tumor suppressor therapy for the treatment of Li-Fraumeni
Syndrome cancers (LFS).
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,
LFS patients often develop spontaneous and widespread tumors at an early
age. Frequently, multiple members of the same family suffer from this
genetic disorder and there are no approved therapies to specifically
treat LFS.
The Company submitted the MAA under the EMEA’s
Exceptional Circumstances Approval rules for breakthrough therapies for
rare diseases such as LFS. Therefore, approval, if granted, will be
based on clinical results from the use of ADVEXIN in LFS, a designated
orphan indication for the drug in Europe, and also from results of other
trials with ADVEXIN in a wide variety of non-inherited solid tumors that
share the p53 biomarker abnormality, which characterizes LFS.
"The submission is an important milestone
achievement for the company in the development of ADVEXIN,”
said Dr. Max W. Talbott, Introgen’s senior
vice president of Worldwide Regulatory Affairs. "This
announcement is the first of multiple anticipated registration
submissions for Introgen. We are also on track to make two additional
ADVEXIN submissions in 2007, one in the U.S. and one in Europe, for
recurrent head and neck cancer.” About ADVEXIN
ADVEXIN is a targeted molecular therapy with the potential to be broadly
applicable across 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 increased survival and tumor growth control in recurrent
head and neck cancer.
About Introgen Therapeutics, Inc. and Gendux Molecular Limited
Introgen Therapeutics, Inc. 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. The Company 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. ADVEXIN®, its lead
product candidate, targets abnormal p53, a fundamental cancer defect
present in over 50 percent of all tumors. Introgen is analyzing its
phase 3 clinical trial for recurrent head and neck cancer using ADVEXIN
as a monotherapy. GML, a subsidiary of Introgen, is engaged in the
development and commercialization of targeted, molecular medicines for
European markets.
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 Li-Fraumeni Syndrome cancers and the acceptance of Introgen
and 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.
Editor's Note: For more information on Introgen Therapeutics, or for a
menu of archived press releases, please visit Introgen’s
Website at: www.introgen.com. For
more information on Gendux, please visit the Website at www.gendux.com.