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Trial Supported by $1.3 Million Award from National Cancer Institute
AUSTIN, TX and TAMPA, FL, USA | February 13, 2008 | Introgen Therapeutics, Inc. (NASDAQ:INGN) and Moffitt Cancer Center today announced that a randomized, controlled study of INGN 225, Introgen's immunotherapy product has been initiated in patients with metastatic small-cell lung cancer (termed extensive stage SCLC).
Introgen and Moffitt previously announced that the National Institutes of Health National Cancer Institute awarded a grant of approximately $1.3 million to fund the trial based upon the promising results of previous clinical studies in small-cell lung cancer patients.
INGN 225 is a p53 immunotherapy using a patient's own cells to stimulate an anti-tumor immune response to fight cancer. The immunotherapeutic targets the p53 tumor suppressor molecular abnormality found in over half of all solid cancers.
Patients with SCLC have an extremely poor prognosis despite frequent initial responses to chemotherapy. p53 abnormalities occur in the majority of SCLC patients and these patients are expected to be well-suited to the testing of the clinical efficacy of INGN 225.
The controlled, randomized phase 2 trial, which will be led by Principal Investigator Dr. Alberto Chiappori, in the Department of Interdisciplinary Oncology at Moffitt, will evaluate the efficacy and safety of INGN 225 in as many as 80 patients with extensive stage SCLC at multiple centers.
Results from a previous Phase 2 trial using INGN 225 in this indication were presented at the annual meeting of the American Society of Clinical Oncology in 2007 and showed a 45 percent response rate in patients with chemotherapy-resistant small-cell lung cancer, who received chemotherapy following INGN 225. 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.
About 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 2008 there will be over 200,000 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 poor 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. (Source: American Cancer Society)
About INGN 225
INGN 225 is an investigational immunotherapy that delivers the p53 tumor suppressor to a patient's immune cells, stimulating an anti-tumor immune response. Dendritic cells are collected from patients following chemotherapy, and are combined with Introgen's proprietary p53 preparation in the laboratory to generate the INGN 225 immunotherapy.
About H. Lee Moffitt Cancer Center & Research Institute
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 as well as for 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(R), its lead product candidate, targets the p53 tumor suppressor and p53 regulatory pathway, which is associated with over 50 percent of all tumors. The Company plans to complete regulatory filings in both the United States and in Europe in the first half of 2008.
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.
SOURCE: Introgen Therapeutics, Inc.
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