dadstimeon Posted May 18, 2005 Share Posted May 18, 2005 http://www.prnewswire.com/cgi-bin/stori ... 079&EDATE= ORLANDO, Fla., May 17 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN) today provided an update of its ongoing clinical development of INGN 401, a nanoparticle formulation of the tumor suppressor gene FUS1. New preclinical data highlighting the potential of INGN 401 alone and in combination with Iressa® (Gefitinib) in the treatment of non-small cell lung cancer were reported. The data were presented today (Abstract #7081) at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando. Introgen researchers and their colleagues at The M. D. Anderson Cancer Center (MDACC) and The University of Texas Southwestern Medical Center are conducting the studies of INGN 401. "The preclinical data presented today are very encouraging because they suggest that INGN 401 may have utility as a monotherapy and may also help to improve chemotherapy response rates in patients with lung cancer," said Sunil Chada, Ph.D., associate vice president, Clinical Research at Introgen. "The five-year survival of patients with non-small cell lung cancer is only 15 percent, and these patients have significant unmet medical needs. These preclinical findings support the utility of INGN 401 in the treatment of lung cancer, and support our ongoing Phase 1 clinical trial of INGN 401 in this disease. The data illustrate that our nanoparticle delivery system may provide a novel approach to the systemic delivery of gene-based cancer therapies." Significant inhibition of tumor growth in animal models of lung cancer was observed following INGN 401 monotherapy treatment compared with untreated animals. In addition, INGN 401 demonstrated synergistic activity with Gefitinib, a novel class of anti-cancer agents that decrease tumor growth by inhibiting growth factor receptors that promote tumor proliferation. While Gefitinib can produce dramatic responses in a small subset of lung cancer patients, most lung cancers are refractory to its effects. In the reported studies, nanoparticle delivery of INGN 401 synergized with Gefitinib in killing lung tumor cells resistant to Gefitinib alone. Furthermore, in Gefitinib-sensitive tumors, INGN 401 delivery significantly enhanced anti- cancer activity. A Phase 1 clinical trial of INGN 401 in patients with stage IV non-small cell lung cancer is in progress. This study is evaluating intravenous delivery of INGN 401 as monotherapy for patients with advanced lung cancer who have experienced disease progression while on chemotherapy. About Introgen 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. 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. 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 not limited to, 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 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 annual report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2005 and its quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2005. 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: http://www.introgen.com . Contact: Introgen Therapeutics, Inc. C. Channing Burke (512) 708 9310 Ext. 322 Email: c.burke@introgen.com SOURCE Introgen Therapeutics, Inc. Web Site: http://www.introgen.com http://www.asco.org/ac/1,1003,_12-002092,00.asp Quote Link to comment Share on other sites More sharing options...
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