Gendux Announces Acceptance of Its ADVEXIN Marketing Authorization Application for Review by the EMEA
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Gendux Molecular Limited ("Gendux”)
announced today that its Marketing Authorization Application ("MAA”)
for ADVEXIN® ("contusugene
ladenovec”) has been accepted for technical
review by the European medicines regulatory authority (the "EMEA”)
for the treatment of an inherited cancer, Li-Fraumeni Syndrome ("LFS”).
Gendux announced the submission of its MAA for ADVEXIN with the EMEA on
13th November 2007. ADVEXIN is the first
treatment specific for an inherited cancer syndrome. ADVEXIN acts by
reversing one of the most common cancer genetic defects, abnormal p53
tumor suppressor levels that are inherited in Li-Fraumeni patients and
which are found in the majority of non-inherited cancers. ADVEXIN is
also being developed for head and neck cancer and filings for this
indication are anticipated before the end of 2007 both in Europe and the
US.
The acceptance of the MAA for ADVEXIN will initiate the regulatory
review of the Application’s preclinical,
manufacturing and clinical data by the EMEA. Gendux is utilizing the
Exceptional Circumstances Approval rules available in Europe to expedite
review of potential breakthrough therapies. The review will be based on
clinical efficacy and safety results from the use of ADVEXIN in LFS and
in a wide variety of non-inherited cancers with abnormal p53 tumor
suppression, the target of ADVEXIN treatment. Abnormal p53 is inherited
in LFS and is also the most commonly identified defective gene in all
solid cancers whether inherited or acquired. An important aspect of
ADVEXIN therapy is that patients’ tumors can
be checked to determine if they have the p53 abnormality targeted by
ADVEXIN using widely available diagnostic tests.
Dr. Max Talbott, senior vice president of Worldwide Regulatory Affairs,
said, "The acceptance of our ADVEXIN
application is a historic moment in the development of gene therapy. If
approved, ADVEXIN will be the world’s first
specific treatment for an inherited cancer syndrome and could represent
a totally novel, personalized approach for a broad range of cancers. The
EMEA’s response to our filing reflects both
the regulatory quality of our Application and the EMEA’s
readiness to begin the technical review. We look forward to our
interactions with the EMEA and the opportunity of bringing this
breakthrough treatment to the market as quickly as possible for the
treatment of this devastating disorder.” About ADVEXIN
ADVEXIN p53 therapy is a targeted gene 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 has demonstrated tumor
growth control in recurrent head and neck cancer, lung cancer, breast
cancer, esophageal, prostate and other cancer indications. ADVEXIN has
demonstrated clinical activity in a number of solid tumor types in
multiple phase 1, 2 and 3 clinical trials conducted worldwide.
About Li-Fraumeni Syndrome
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,
cancer patients can lose the ability to naturally combat cancer. Without
a normally functioning p53 defence, LFS cancer patients often develop
spontaneous and widespread tumors at an early age. Frequently, multiple
members of the same family suffer from this genetic disorder and
currently there are no approved therapies to specifically treat LFS.
About Gendux Molecular Limited
Gendux Molecular Limited is a non-resident Irish company based in
Dublin, Ireland. The Company is focused on the commercialization of
targeted molecular therapies to be applied with molecular diagnostic
tools to introduce personalized medical products in European and other
markets. Gendux is a subsidiary of Introgen Therapeutics, Inc. For more
information on Gendux, or for a menu of archived press releases, please
visit Gendux’s Website at: www.gendux.ie.
About Introgen Therapeutics, Inc.
Introgen (NASDAQ:INGN) 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. Introgen 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. For more information on Introgen
Therapeutics, or for a menu of archived press releases, please visit
Introgen’s Website at: www.introgen.com.
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 LFS cancers, the approval of ADVEXIN for LFS in European
markets, and the acceptance of 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.