Correction to Press Release Dated May 28, 2008: ADVEXIN(R) Improves Survival in Recurrent, Refractory Head and Neck Cancer Patients
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Introgen Therapeutics, Inc. (NASDAQ:INGN) announced today the following
correction to its press release dated May 28, 2008 and titled "ADVEXIN®
Improves Survival in Recurrent, Refractory Head and Neck Cancer Patients.”
The correction pertains to the median survival in the ITT population.
The correct information is: "As expected from
the p53 biomarker profiles data indicating efficacy in different
patients, there was no statistical difference in survival between
ADVEXIN and methotrexate in the ITT population which included both p53
favorable and unfavorable patients in both study arms (median survival
4.4 vs. 6.1 months; p = 0.236).”
To access the full data presentation presented at the American Society
for Gene Therapy annual meeting in Boston earlier today, visit the
Events page on Introgen’s web site at www.introgen.com.
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.
The data, opinions and conclusions presented in this release and in the
above referenced ASGT presentation are preliminary. This information and
additional relevant information have not yet been presented in their
entirety to the U.S. Food and Drug Administration (FDA), European
Medicines Evaluation Agency (EMEA) or other regulatory authorities;
although we anticipate submitting materially all of this information to
the FDA, EMEA and corresponding foreign authorities in the future.
Only the FDA, EMEA and corresponding regulatory agencies have the
authority to approve pharmaceutical products. We cannot predict how such
authorities may interpret the information contained in this release and
the referenced ASGT presentation or may respond to our regulatory
submissions.
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.