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Preclinical Studies Identify Novel Approach for Enhancing the Anticancer Activity of Introgen's INGN 241.

Data Published in Molecular Cancer Therapeutics

AUSTIN, Texas -- Introgen Therapeutics, Inc. (NASDAQ:INGN) today announced the publication of new preclinical data describing how an intrinsic cell survival pathway impacts the anticancer activity of INGN 241. Inhibition of this pathway, known as NF-[eth][bar]B, enhanced the tumor killing effects of INGN 241 in cell culture and in preclinical models of human tumors. Researchers at Introgen and The University of Texas M. D. Anderson Cancer Center conducted the studies and the data appear in the current issue of Molecular Cancer Therapeutics.

"These studies demonstrate that mda-7, the active component of INGN 241, activates NF-[eth][bar]B in lung tumor cells," said Rajagopal Ramesh, PhD, associate professor in the Department of Thoracic and Cardiovascular Surgery at M. D. Anderson Cancer Center and principal author on the study. "Although the potent effects of mda-7 ultimately overcome NF-[eth][bar]B and lead to cancer cell death, these studies show that inhibition of NF-[eth][bar]B enhances the anti-cancer activity of INGN 241. This suggests that combining INGN 241 with NF-[eth][bar]B inhibitors could yield improved clinical effects. Many pharmaceutical companies are actively developing drugs targeting NF-[eth][bar]B, and these agents should enhance activity of INGN 241."

A variety of chemotherapies and cytokines used in the treatment of cancer are known to activate NF-[eth][bar]B signaling. The current studies were undertaken to assess if INGN 241 had a similar effect. Results of tissue culture studies indicated that NF-[eth][bar]B levels in lung cancer cells were higher following administration of INGN 241 compared with controls and increased in a time-dependent manner. Additional cell culture analyses demonstrated that INGN 241 inhibited cell proliferation in cells with activated NF-[eth][bar]B, and that this effect was enhanced with inhibition of NF-[eth][bar]B. INGN 241 activity also was enhanced in animal models of lung tumors engineered to inhibit NF-[eth][bar]B activation. The studies also identified two other proteins, MEKK1 and caspase-3, which mediate the cell-killing effects of INGN 241.

Based on these results, it is anticipated that the combination of INGN 241 and inhibitors of NF-[eth][bar]B will have an enhanced therapeutic effect and be suitable for clinical evaluation.

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.

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.

Introgen holds a licensing agreement with M. D. Anderson Cancer Center to commercialize products based on licensed technologies, and has the option to license future technologies under sponsored research agreements. The University of Texas Board of Regents owns stock in Introgen. These arrangements are managed in accordance with M. D. Anderson's conflict of interest policies.

Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to Introgen's future success with its INGN 241 clinical development program in combination for treatment of cancer. 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.
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Publication:Business Wire
Date:Apr 25, 2007
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