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Introgen's P53 Immunotherapy Drug Candidate to Advance Into Second Phase 2 Clinical Trial in Small Cell Lung Cancer With National Cancer Institute

Posted on: Thursday, 6 September 2007, 09:10 CDT

Introgen Therapeutics, Inc. (NASDAQ:INGN) and Moffitt Cancer Center today announced plans to begin a phase 2 randomized, controlled study of INGN 225, Introgen's investigational immunotherapy product in patients with metastatic small-cell lung cancer (termed extensive stage SCLC).

INGN 225 is an immunotherapy using a patient's own cells to stimulate an anti-tumor immune response to fight cancer. The immunotherapeutic targets a molecular abnormality found in over half of all solid cancers.

The National Institutes of Health National Cancer Institute awarded a grant of approximately $1.3 million to fund this trial, which is expected to enroll as many as 80 patients starting early next year upon completion of the protocol with the NCI and U.S. Food and Drug Administration.

Results from a previous Phase 2 trial were presented today at the 12th World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer, in Seoul, Korea showing a 45 percent response rate in patients with platinum-resistant small-cell lung cancer who received chemotherapy following INGN 225. Interim results from this study also were presented earlier this year at the annual meeting of the American Society of Clinical Oncology. The historical response rate is generally less than 15 percent in these patients. Among the 43 patients evaluable for survival following INGN 225 treatment, survival was also improved compared to historical controls.

"The data to date indicate that INGN 225 could be a promising treatment in terms of survival, response rate and tolerability in a disease with virtually no treatments after chemotherapy has failed," said Dr. Dmitry Gabrilovich, professor of Oncology at Moffitt Cancer Center. "We are looking forward to confirming these earlier findings in a randomized, controlled phase 2 study that, if successful, could be expanded to become a registration study since there is such an acute medical need for new treatments in patients with extensive stage small-cell lung cancer resistant to chemotherapy."

The controlled, randomized trial, which will be co-led by Dr. Scott Antonia, program leader, Immunology and medical director, Cellular Therapies Core, and Dr. Gabrilovich, is being designed to evaluate the efficacy and safety of INGN 225 in patients with extensive stage SCLC at multiple centers and will include a control arm.

About Small-Cell Lung Cancer

Lung cancer is the leading cause of cancer death for both men and women. More people die of lung cancer than colon, breast and prostate cancers combined. In 2007 there will be 213,380 new cases of lung cancer. About 15-20 percent of all lung cancers are small-cell lung cancer. Patients with extensive stage (metastatic) small-cell lung cancer have a dismal prognosis and most live less than 10 months. This cancer often starts in the bronchi near the center of the chest, although the cancer cells often multiply quickly to form tumors that spread widely through the body. This is important because it means the treatment must include drugs that kill the widespread disease. (Source: American Cancer Society)

About INGN 225

INGN 225 is an investigational immunotherapy that delivers the p53 tumor suppressor (Ad-p53) to a patient's immune cells, stimulating an anti-tumor immune response. Dendritic cells are collected from patient following the last dose of first-line chemotherapy, and treated in the laboratory with Ad-p53, to generate the INGN 225 immunotherapy.

About Moffitt Cancer Center

Located in Tampa, Florida, Moffitt Cancer Center (www.moffitt.org) is the only Florida-based cancer center with the NCI designation as a Comprehensive Cancer Center for its excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 15 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in U.S. News & World Report as one of "America's Best Hospitals" for cancer and ear, nose and throat. Moffitt's sole mission is to contribute to the prevention and cure of cancer.

About Introgen Therapeutics, Inc.

Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the development, manufacturing and commercialization of targeted tumor suppressors, a new class of therapies for the treatment of cancer. Introgen's technology delivers targeted molecular therapies that increase production of normal cancer-fighting proteins and cytokines. The Company is developing a proprietary pipeline of product candidates utilizing molecular biomarkers to identify patients most likely to benefit from its therapies which target central cancer-causing mechanisms. ADVEXIN®, its lead product candidate, targets abnormal p53, a fundamental cancer defect present in over 50 percent of all tumors. Introgen is analyzing its phase 3 clinical trial data for recurrent head and neck cancer using ADVEXIN as a monotherapy. The Company plans to complete regulatory filings in both the United States and in Europe by the end of 2007. For more information about the Company, please visit www.introgen.com.

Forward-Looking Statements

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 225 clinical development program for the treatment of small-cell 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: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen's Website at: www.introgen.com.

Editor's Note: The project is supported by Grant Number R01CA120282 from the National Cancer Institute.

Source: Business Wire

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