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Abstract:
Introgen Therapeutics, Inc. today reported results from preclinical studies of its INGN 401 product candidate, nanoparticle tumor suppressor therapy in an animal model of metastatic lung cancer.

Introgen's INGN 401 Systemic Nanoparticle Therapy Extends Survival by Nearly 70 Percent in Preclinical Model of Metastatic Lung Cancer

Phase 1 Clinical Studies Ongoing

Austin, TX – November 11, 2004

Introgen Therapeutics, Inc. (Nasdaq: INGN) today reported results from preclinical studies of its INGN 401 product candidate, nanoparticle tumor suppressor therapy in an animal model of metastatic lung cancer. INGN 401 is a nanoparticle formulation of the tumor suppressor gene FUS1. The data from these studies demonstrate that intravenous administration of FUS1 significantly suppressed tumor growth, inhibited metastasis and prolonged survival in mice with metastatic lung cancer. Mice treated with INGN 401 survived almost 70 percent longer than untreated mice. Researchers at The University of Texas M. D. Anderson Cancer Center and The University of Texas Southwestern Medical Center conducted the studies. The data appear in the current issue of Cancer Gene Therapy. INGN 401 is currently in Phase 1 clinical trials in patients with lung cancer and initial survival results are encouraging.

"A key challenge in treating metastatic cancer is the ability to attack cancer at multiple sites throughout the body without causing systemic toxicity," said Dr. Sunil Chada, Introgen's director of Research and Development. "Combining the systemic delivery capabilities of the nanoparticle delivery with the cancer-specific activity of tumor suppressor genes, such as FUS1, may provide a new approach to addressing that challenge. These data are particularly exciting because of the significant survival benefit observed following treatment with INGN 401. Lung cancer is the leading cause of death in the Western world, and we believe that this therapy offers great potential in helping to meet the significant unmet medical needs of patients with metastatic disease."

In these studies, INGN 401 was evaluated in mice bearing tumors derived from two human lung cancer cell lines. Direct intratumoral injection of INGN 401 resulted in significant suppression of tumor growth compared with controls, with some animals showing complete tumor regression. Intravenous administration of INGN 401 resulted in a 75 percent inhibition of lung metastases compared with controls. Importantly, this systemic tumor growth control resulted in a 67 percent increase in average survival in INGN 401 treated animals. Furthermore, 40 percent of treated animals were still alive at the end of the study (day 125), whereas all control animals died by day 75. Analysis of tumor tissue indicated that apoptosis (cell suicide) was significantly elevated in tumors treated with INGN 401. No significant treatment-related toxicity was observed.

"The systemically delivered nanoparticles can be used to deliver a variety of tumor suppressors and may open the door to a variety of novel cancer therapies," said Dr. Rajagopal Ramesh, Assistant Professor in the Department of Thoracic and Cardiovascular Surgery. "This approach is especially attractive for the treatment of metastatic cancer, in which multiple tumors may exist at disparate locations throughout the body. Being able to deliver cancer-specific tumor suppressor genes, such as FUS1 and p53, may provide new therapeutic options for cancer patients."

About Introgen

Introgen is a leading developer of biopharmaceutical products designed to induce therapeutic protein expression using non-integrating gene agents for the treatment of cancer and other diseases. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates a commercial-scale, CGMP manufacturing facility.

Introgen holds a licensing agreement with M. D. Anderson 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 own stock in Introgen. These arrangements are managed in accordance with M. D. Anderson's conflict of interest policies.

Certain statements in this press release that are not strictly historical may be "forward-looking" statements, which are based on current expectations and entail various risks and uncertainties. Such forward-looking statements include, but are not limited to, those relating to Introgen's future success with its clinical development program for INGN 401 for lung and other cancers. There can be no assurance that Introgen will be able to commercially develop gene-based drugs, that necessary regulatory approvals will be obtained or that any clinical trials or studies undertaken will be successful or that the proposed treatments will prove to be safe and/or effective. The actual results may differ from those described in this press release due to risks and uncertainties that exist in Introgen's operations and business environment, including, but without limitation, Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, Introgen's dependence upon proprietary technology and current competition, 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, 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. 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.

Contact:
Introgen Therapeutics, Inc.
C. Channing Burke
(512) 708 9310 Ext. 322
c.burke@introgen.com

Copyright © Introgen

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