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Introgen Obtains Exclusive US Patent for Development of Adenoviral Vector Based Gene Therapies
Wednesday, July 18, 2007
Austin, TX -- Introgen Therapeutics, Inc. (Nasdaq: INGN) announced today that a patent has been awarded titled "Diminishing Viral Gene Expression by Promoter Replacement" by the U.S. Patent and Trademark Office focusing on adenoviral vector development, which is the most commercially important type of viral vector used in the field of gene therapy. The patent, U.S. Patent No 7,244,617, is one of numerous patents, pending or issued, that Introgen has licensed exclusively from The University of Texas System M. D. Anderson Cancer Center.
David L. Parker, Ph.D, J.D., Introgen’s senior vice president of Intellectual Property, commented, "This patent is a significant addition to Introgen’s intellectual property portfolio in that it covers viral vectors with genetic modifications that will permit researchers to easily control the replication of such vectors by, for example, supplying an inducing factor, which can prevent unwanted vector replication in patients."
The claims of this patent also cover the deletion of multiple viral genes within a vector. Deleting multiple viral genes allows for the insertion of numerous or large therapeutic genes, including tumor suppressor genes. Alternatively, the deletion of the multiple viral genes from the vector allows for one or two large therapeutic genes. This patent also covers the adenoviral vector’s use with pro-apoptotic genes, currently designed to induce cell death in the target cell, one of the desired outcomes in treating cancer.
Adenoviruses are clinically important viruses used to deliver therapeutic or diagnostic genes to cells and have been used in hundreds of thousands of patients in government, industry and academia for vaccine and therapy programs. Adenoviruses can be genetically altered so that they are unable to replicate in humans and they do not mix with a patient’s DNA. Adenoviruses have important properties that lend themselves readily to commercial scale manufacturing. Introgen’s own adenoviral vector based therapies include ADVEXIN p53 therapy and INGN 241 mda-7 therapy. There currently are hundreds of development programs around the world for adenoviral-based therapies, including oncolytics, gene and protein delivery for cancer, cardiovascular, ophthalmologic, siRNA, and numerous other direct therapies, as well as forming the basis for the next generation of vaccines. All of these technologies will potentially benefit from the technology covered by this patent.
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 1, 2 and 3 clinical trials conducted worldwide.
About INGN 241
INGN 241 is being tested in a Phase 2 clinical trial for patients suffering from advanced melanoma and in a Phase 3 clinical trial in combination with radiation therapy in solid tumors. The mda-7 gene is the active component of INGN 241 and was discovered in the laboratory of Dr. Paul B. Fisher, professor of clinical pathology at Columbia University. Introgen holds an exclusive worldwide sublicense to the Columbia University rights for all gene therapy applications from GlaxoSmithKline.
Introgen Therapeutics, Inc. (www.introgen.com) 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 therapies to treat a wide range of cancers using tumor suppressors and cytokines. 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 and INGN 241 clinical development programs for treatment of cancer and patents related to adenoviral vector development. 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.
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