Guest guest Posted December 15, 2003 Report Share Posted December 15, 2003 New Technology Accelerates Development Of Introgen's Novel Anti- Cancer Candidate INGN 007 12/12/2003 Source: Introgen Therapeutics, Inc. Significant advances related to the development of Introgen Therapeutics, Inc.'s novel anti- cancer product candidate, INGN 007 (VRX 007) were presented today at the 12th International Conference on Gene Therapy of Cancer, which is being held in San Diego. INGN 007, which Introgen licensed from VirRx, Inc. earlier this year, is a proprietary, engineered adenovirus with multiple cancer killing properties. New data related to the development of novel animal models of cancer in which to test the potential efficacy and safety of INGN 007 were presented by Introgen's collaborator, Dr. S.M. Wold, founder and CEO of VirRx and chairman of the Department of Molecular Microbiology and Immunology at St. Louis University School of Medicine. The study, titled " Adenovirus oncolytic vectors that overexpress ADP, " reviewed previously presented data on oncolytic viruses and described the production of novel animal models that allow these viruses to be tested in a setting that more accurately reflects human cancer. Dr. Wold said, " Oncolytic viruses have demonstrated significant potential in the treatment of cancer, and provide a new focus for drug development efforts. Having generated a robust body of proof-of- concept data in existing animal models, we now have the tools we need to advance this promising technology more quickly toward the clinic. With the model we presented today, the animals retain a functioning immune system and also permit infection by and replication of these novel adenoviral vectors. We believe that this model will further our understanding of how oncolytic viruses may be used to treat cancer in humans. " Studies of tumor responses to oncolytic viruses to date have been conducted in mice that lack a functioning immune system. These models allow human tumors to be implanted into the mice without stimulating the mouse immune system to attack the implanted tissue. Oncolytic viruses have demonstrated a powerful ability to suppress tumor growth in these models. However, mouse cells do not support replication of these adenoviral vectors and the lack of a functioning immune system makes it difficult to draw direct parallels between effects observed in these models and potential effects in human cancers. INGN 007 (VRX-007) is a replication competent adenovirus vector that over- expresses an adenoviral gene (ADP) that causes rapid disruption (oncolysis) of tumor cells in which it replicates. The ability to overexpress the ADP gene sets this technology apart from other existing oncolytic viruses and has been shown to provide a powerful antitumor effect. Introgen holds an exclusive license to this technology from VirRx. INGN 007 and related vectors have been genetically engineered to increase their safety. In addition, some vectors incorporate certain genetic features that permit the vectors to replicate selectively in tumor cells. Additionally, some of these vectors have been further modified by the addition of genes that specifically kill cancer cells. These vectors have been extensively tested in cell and animal models and shown to be very highly active in killing tumor cells. 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 oncolytic viruses in the treatment of cancer or 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, including its annual report on Form 10-K filed on March 31, 2003 and its quarterly report on Form 10-Q filed on November 14, 2003, and its prospectus supplement filed with the SEC pursuant to Rule 424((2) on November 26, 2003. 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/ . Quote Link to comment Share on other sites More sharing options...
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