29.05.2008 19:15:00
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ADVEXIN(R) Pivotal Phase III Data Presented as Part of Late-Breaking ASGT Presentation
Study results from Introgen Therapeutics, Inc.’s
(NASDAQ:INGN) phase III ADVEXIN®
(p53 tumor suppressor therapy) clinical trial were presented as a
late-breaking, oral presentation earlier today at the American Society
for Gene Therapy (ASGT) annual meeting in Boston, Mass. To access the
ASGT presentation on Introgen’s web site
please visit the Events page at www.introgen.com.
The results demonstrate that ADVEXIN has significantly increased
survival in end-stage head and neck cancer patients.
Data was presented by study principal investigator, John Nemunaitis, MD,
medical director, Mary Crowley Cancer Research Centers at Baylor-Charles
A. Sammons Cancer Center in Dallas, TX. The presentation and ADVEXIN
therapy was also described in a news release from Mary Crowley Cancer
Research Centers titled Groundbreaking Clinical Trial at Mary Crowley
Significantly Increases Survival in End-Stage Head and Neck Cancer
Patients http://www.marketwire.com/mw/release.do?id=862178&k=mary%20crowley
and in a news release from M.D. Anderson Cancer Center titled Gene
Therapy Increases Survival for End-Stage Head and Neck Cancer. http://www.mdanderson.org/departments/newsroom/display.cfm?id=4376DB08
-82BB-4FCB-9FAB5CF9FA51DEFF&method=displayFull&pn=00c8a30f-c468-11d4-8
0fb00508b603a14. (Due to its length, this URL may need to be
copied/pasted into your Internet browser's address field. Remove the
extra space if one exists.)
Jack A. Roth, MD, Professor and Bud Johnson Clinical Distinguished
Chair, Department of Thoracic & Cardiovascular Surgery, Section Chief,
Thoracic Molecular Oncology, and Director, W.M. Keck Cancer Center for
Innovative Cancer Therapies, M.D. Anderson Cancer Center, Houston, TX
was recognized for his contributions as the inventor of ADVEXIN.
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 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 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.
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.
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