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urrent Head... ORLANDO, Fla., March 30 /PRNewswire-FirstCall/ -- Introgen Therapeutics today reported combined safety and efficacy results based on three multi-center, multi-national Phase 2 clinical trials of Advexin(R) p53 gene therapy in 217 patients with recurrent, squamous cell carcinoma of the head and neck. These data were presented in a late breaking session at the 95th annual meeting of the American Association of Cancer Research taking place March 27-31, 2004 in Orlando, Florida. The objective overall response rate of Advexin monotherapy was 10 percent (complete and partial response with greater than 50 percent reduction in tumor size). Tumor growth control (stable disease or better) was achieved in 59 percent of all treated lesions. The primary objective of the trials was to assess tumor growth control and safety following Advexin monotherapy in patients with recurrent head and neck cancer. All patients had failed previous conventional treatment. "The primary endpoint results from the three Phase 2 trials confirm our previously reported findings regarding the activity and safety of Advexin," stated Robert E. Sobol, M.D., Introgen''s senior vice president of medical and scientific affairs. "This multi-center, multi-national analysis is the first detailed report of the combined data from all of our Phase 2 trials in recurrent head and neck cancer. These results were collected from over 40 clinical sites in the U.S. and Europe. We are encouraged by the response and safety data and the consistency of the findings." Secondary endpoints of the studies included assessments of patient survival. A difference was observed between patients treated with high doses and low doses of Advexin. Patients treated with higher doses had a statistically significant increase in median survival compared to patients treated with lower doses (243 vs. 119 days). Additionally, the overall median survival was longer in patients who were treated with Advexin followed by chemotherapy in each of the studies: Trial 202 (n=20) 330 days; Trial 201 (n=47) 260 days; Trial 207 (n=29) 246 days. Advexin therapy was administered by intra-tumoral injections. Advexin treatment-related side effects were generally mild to moderate in nature and included transient injection site pain and fever. All patients had been previously treated with radiation therapy and 59 percent had previous chemotherapy. To date, clinical investigators in North America, Europe and Japan have treated over 500 patients with several thousand doses of Advexin therapy, establishing a large safety database. "We will continue to monitor the survival data from these Phase 2 uncontrolled, non-randomized studies and will further analyze survival duration as part of our ongoing controlled and randomized Phase 3 clinical trials in recurrent head and neck cancer patients," added Dr. Sobol. About Advexin There are two multi-national, multi-site Phase 3 trials of Advexin therapy, currently underway in recurrent squamous cell cancer of the head and neck. Introgen has received FDA Fast Track designation for Advexin therapy and Advexin has been designated as an Orphan Drug for the treatment of head and neck cancer under the Orphan Drug Act. Advexin has been evaluated in a variety of cancer types and in combination with several standard cancer therapies, including radiation and chemotherapy. Data from several published preclinical and clinical studies have demonstrated the ability of Advexin to safely enhance the anti-cancer effects of radiation and chemotherapy treatment. Advexin supplies p53 protein in very high concentrations in cancer tissue and selectively kills cancer cells. p53 is a normal constituent of cells and is known as a tumor suppressor because it inhibits the growth of tumor cells. One of the major roles of this protein is to eliminate cancerous cells by recognizing when the cell has been damaged by mutations and stopping cell growth to initiate repair. If the cell is damaged beyond repair, p53 initiates the cell death pathway to prevent the cell from growing out of control. About Introgen 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 Advexin clinical development program for cancer and other diseases. 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 without limitation, 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 current competition, 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, 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. 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. 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) 965 0907 (Cell) (512) 708 9310 Ext. 322 (Office) Email: c.burke@introgen.com Introgen''s Booth in Exhibit Hall #1335 Introgen Therapeutics, Inc. © PR Newswire

Kurzkommentar: positive News am Wochenende sollten weiteren starken Kaufdruck auslösen, was m. M. nach zum Breakout führen wird. Gruß und schönes WE

Introgen to Present Advexin(R) and INGN 241 Data at Annual Meeting ... AUSTIN, Texas, March 23 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. will update its progress in the development of Advexin(R) and INGN 241 at the 95th annual meeting of the American Association of Cancer Research (AACR) held in Orlando, Florida. Advexin currently is in phase 3 trials for the treatment of head and neck cancer and INGN 241 is being evaluated in phase 1 and phase 2 clinical trials for multiple tumor types. Nine abstracts related to Introgen''s drug candidates will be presented during the conference, which will be held March 27 - March 31, 2004. Two INGN 241 abstracts will be presented on Sunday, March 28; two on Tuesday, March 30 and four on Wednesday, March 31. One Advexin abstract will be presented on Tuesday, March 30. -- Abstracts 584 and 568 will be presented in poster sessions from 8:00 a.m. to 12:00 p.m. ET on Sunday, March 28. -- Abstract 3778 will be presented in a poster session from 8:00 a.m. to 12:00 p.m. ET on Tuesday, March 30. -- Abstracts LB-331 and 4402 will be presented in poster sessions from 1:00 p.m. to 5:00 p.m. ET on Tuesday, March 30. -- Abstracts 5303, 5135, 4970 and 4891 will be presented in poster sessions from 8:00 a.m. to 12:00 p.m. ET on Wednesday, March 31. All publications may be accessed online at http://www.aacr.org/ . The presentations will not be web cast. 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 with Advexin and INGN 241 for cancer and other diseases. 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 without limitation, 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 current competition, 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, 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. 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 Introgen Therapeutics, Inc. © PR Newswire Gruß