Introgen Receives Broad U.S. Patent for Improved Storage-Stable Formulations of its Adenoviral-Based Pharmaceuticals

Introgen Therapeutics, Inc. (NASDAQ:INGN) announced today that a patent covering adenovirus compositions including its product ADVEXIN has been awarded by the by the U.S. Patent and Trademark Office. Patent number 7,235,391, titled Formulations of Adenovirus for Gene Therapy, relates to improved pharmaceutical formulations for the long-term storage of adenoviruses. David L. Parker, Ph.D, J.D., Introgen’s senior vice president of Intellectual Property said, "The issuance of this patent is significant for Introgen in that the development of adenoviral formulations with improved storage stability and ease of shipping and handling is a is sought-after goal by the adenovirus industry in general and Introgen specifically. The formulations covered by this patent achieve these important goals.” The technology covered under this patent was developed as the result of extensive testing and investigation by Introgen’s viral formulations group, and is based on the finding that long term storage of adenovirus particles under reasonable storage and shipping conditions (for example, 4º C.) could be achieved using relatively simple combination of components, such as glycerol and non-ionic detergents. Such formulations provide Introgen the capability to distribute its adenoviral drug candidates, such as its ADVEXIN p53 and INGN 241 mda-7 therapies, using simplified procedures, as well as ultimately providing pharmacies the ability to store such therapeutics for longer periods of time under more typical drug storage conditions. Adenoviruses are clinically important viruses used in the delivery of therapeutic or diagnostic genes to cells, such as the delivery of tumor suppressor genes to cancer cells. Adenovirus has 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. Moreover, there are currently 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 benefit from the technology covered by this patent. 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 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. 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 pharmaceutical formulations for the long-term storage of adenoviruses such as those utilized in ADVEXIN and INGN 241. 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. 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.