Introgen's Intravenous Nanoparticle Gene Therapy Shows

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Activity in Stage IV Lung Cancer Patients

http://www.genengnews.com/news/bnitem.a ... e=15808927

Apr 17 2007, 4:36 PM EST

Business Wire

A cancer-suppressing gene has been successfully delivered into the tumors of stage IV lung cancer patients via Introgen Therapeutics, Inc.'s (NASDAQ:INGN) intravenously administered lipid nanoparticle product candidate INGN 401. In a phase 1 clinical trial conducted at The University of Texas M. D. Anderson Cancer Center, the gene, FUS1, was found to be active in patients' metastatic non-small cell lung cancer tumors.

This is the first clinical demonstration that a gene can be injected intravenously and be taken up and expressed at high levels in cancer cells at distant sites. Lung cancer is the leading cause of cancer death in the United States, causing 160,000 deaths annually. Approximately 80 percent of lung cancer is of the non-small cell type.

Thirteen patients were treated in this first-in-human study with no significant drug-related toxicity. Median survival time for all patients is 14.6 months which compares favorably to a seven-month median survival time for patients receiving second line therapy. All patients on the trial had been treated with front line cisplatin combination chemotherapy, which failed to halt their disease. The clinical trial continues and no maximum tolerated dose has been established.

Blinded analysis of pretreatment and post-treatment biopsies of three patients' tumors show that expression of FUS1 was absent from pretreatment samples while a high level of FUS1 was expressed in tumors after treatment. FUS1 can induce apoptosis - programmed cell death - in cancer cells but is frequently lost when normal cells become cancerous. The study was presented today at the late-breaking abstract session of the annual meeting of the American Association for Cancer Research in Los Angeles.

About INGN 401

The FUS1 nanoparticle formulation was developed and tested at M. D. Anderson Cancer Center. It advanced to clinical testing after promising results were obtained in human non-small cell lung cancer in a mouse model. FUS1 was discovered by a research team led by Jack A. Roth, M.D., Professor and Chair of the M. D. Anderson Department of Thoracic and Cardiovascular Surgery, and by John Minna, M.D., of the Department of Internal Medicine and Pharmacology, Hamon Center for Therapeutic Oncology Research, at The University of Texas Southwestern Medical Center at Dallas. Roth and Minna are the co-principal investigators of a National Cancer Institute Specialized Program of Research Excellence in Lung Cancer. The nanoparticle delivery system consists of a plasmid gene expression cassette loaded with DNA that encodes the FUS1 protein. This is wrapped tightly in a form of cholesterol to protect it from the body's defense mechanisms. The nanoparticles accumulate mainly in the lungs, particularly in the tumors, where the genes repeatedly express FUS1 tumor-suppressing proteins. Introgen and collaborators are working on the design of a pivotal study for INGN 401 and the incorporation of FUS1 biomarkers in INGN 401 development programs.

About Introgen Therapeutics, Inc.

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.

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. Introgen obtained a license to the FUS1 gene from M. D. Anderson Cancer Center. The University of Texas System owns stock in Introgen. These arrangements are managed by M. D. Anderson in accordance with its conflict of interest policies. The nanoparticle delivery system used for INGN 401 has been licensed by Introgen from the National Institutes of Health.

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 401 clinical development program for treatment of metastatic lung 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: The University of Texas M. D. Anderson Cancer Center's press release about this study, issued earlier today, is available at www.mdanderson.org.

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.