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.

NEWS

April 18, 2007

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

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