Introgen Presents Top Line Data from Phase III Advexin Clinical TrialAUSTIN, Texas--(BUSINESS WIRE)--May 29, 2008 - Study results from Introgen Therapeutics, Inc.'s (NASDAQ:INGN) phase III Advexin(R) (p53 tumor suppressor therapy) clinical trial will be presented as a late-breaking, oral presentation 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 presentation will be posted at approximately 11:00 am. E.T. The results demonstrate that ADVEXIN has significantly increased survival in end-stage head and neck cancer patients.
Data will be 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 M.D. Anderson Cancer Center 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 will be recognized for his contributions as the inventor of ADVEXIN. Drs. Nemunaitis and Roth will answer questions at the conclusion of the presentation.
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.
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.
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.
Introgen Therapeutics, Inc., Austin
Channing Burke, 512-965-0907
Posted: May 2008