dadstimeon Posted September 25, 2005 Share Posted September 25, 2005 http://www.prnewswire.com/cgi-bin/stori ... 437&EDATE= AUSTIN, Texas, Sept. 12 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN) presented updated interim results from an ongoing Phase 2 trial of its investigational cancer vaccine, INGN 225, in patients with advanced small cell lung cancer. Results presented over the weekend at the 13th International Conference on Gene Therapy of Cancer show that the vaccine is well tolerated and that INGN 225 appears to sensitize lung tumors to additional chemotherapy, with 62 percent of patients who received second-line chemotherapy exhibiting objective responses. INGN 225 is a personalized vaccine that utilizes the p53 tumor suppressor gene to stimulate a cancer patient's immune system to destroy cancer cells. "These promising results highlight the broad potential of p53-based therapies in the treatment of cancer," said Sunil Chada, Ph.D., Introgen's associate vice president, Clinical Research. "p53, the active component of INGN 225, is typically expressed at undetectable levels in normal cells. In cancer cells, however, levels of p53 are often significantly increased, making this important protein a cancer-specific vaccine target." INGN 225 is an investigational therapeutic vaccine consisting of a cancer patient's dendritic cells, a type of immune cell, treated with an adenovector carrying the human p53 gene (Ad-p53). In the study, patients with extensive stage (advanced) small cell lung cancer were treated with their own dendritic cells combined with Ad-p53. To date, 27 patients have each received at least three doses of the vaccine. Earlier interim results of this study were reported at the annual meeting of the American Society of Clinical Oncology in May. Interim results show that the vaccine was well tolerated, with no appreciable INGN 225 related toxicity in any of the treated patients. Following INGN 225 treatment, 62 percent of the evaluable patients in the study had objective responses to subsequent chemotherapy by standard RECIST (Response Evaluation Criteria in Solid Tumors) criteria. "Historically, the expected objective response rate in patients with this type of advanced lung cancer is less than 25 percent," said Dmitry Gabrilovich, M.D., Ph.D., professor of oncology at the H. Lee Moffitt Cancer Center and co-principal investigator of the study. "The results of post- vaccination second-line chemotherapy are striking -- double what we would predict in this patient population. These data strongly suggest that INGN 225 sensitizes lung cancer cells to the effects of chemotherapy and may in fact significantly enhance the efficacy of subsequent chemotherapy." A Phase 1/2 trial of INGN 225 in patients with breast cancer is ongoing. 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 tumor suppressor therapies to treat a wide range of cancers using non-integrating tumor suppressors, cytokines and genes. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility. Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to Introgen's future success with its clinical development program for treatment of cancer or other diseases and INGN 225 in the treatment of lung and breast cancers. 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: http://www.introgen.com . Contact: Introgen Therapeutics, Inc. C. Channing Burke (512) 708 9310 Ext. 322 Email: firstname.lastname@example.org Quote Link to comment Share on other sites More sharing options...
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