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Introgen Preclinical Studies Show Non-Viral Delivery System Effectively Targets Tumors

Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)


Posted on: 03/01/2003

Introgen Therapeutics, Inc. (ticker: ingn, exchange: NASDAQ) News Release - 2/27/03

Introgen Preclinical Studies Show Non-Viral Delivery System Effectively Targets Tumors

AUSTIN, Texas, Feb 27, 2003 /PRNewswire-FirstCall via COMTEX/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN) announced the publication of preclinical data which showed that its non-viral delivery system may be a more effective method of delivering therapeutic genes to tumors than other non- viral delivery systems. These data were published in the February 2003 issue of the journal Molecular Therapy. Introgen holds a license to pharmaceutical applications of the non-viral delivery system from the National Institutes of Health.

"While current treatments for metastatic tumors have had limited successes, due to toxicity issues, this novel delivery system results in targeting of gene therapeutics to cancer cells, and may have better efficacy and lower toxicity than other non-viral formulations tested to date," said Jack A. Roth, M.D., chair of the Department of Thoracic and Cardiovascular Surgery at M. D. Anderson, and author on the publication. "This is a significant advance in the field of non-viral gene therapy which may have clinical applications in the near future."

The in vivo study demonstrated tumor cell targeting using Introgen's non- viral formulation and was conducted by Dr. Rajagopal Ramesh, assistant professor in the Department of Thoracic and Cardiovascular Surgery at The University of Texas M. D. Anderson Cancer Center. The tumor targeting appeared to be due to preferential uptake by tumor cells of the non-viral gene formulations. When the non-viral formulation was administered to cells in culture, tumor cells showed much greater uptake and gene expression than normal cells. When injected intravenously into mice, a similar effect was observed, with both uptake and gene expression higher in tumors than surrounding normal tissues. These same results were observed in culture using human tumor samples from patients undergoing surgery for lung cancer.

"Introgen and its academic collaborators continue to advance the science of using genes as therapeutic agents," said David G. Nance, Introgen's president and CEO. "These data and other research progress in Introgen's non- viral delivery program are very encouraging. We look forward to the clinical testing of this promising system," he continued.

Introgen is a leader in the development and production of gene-based drugs 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. Through more than 20 clinical trials, the company has treated hundreds of patients with thousands of doses of its lead product candidate, ADVEXIN(R) p53 therapy. Introgen is conducting two controlled, randomized phase 3 clinical trials with ADVEXIN for the treatment of head and neck cancer, a phase 2 study in breast cancer, as well as a phase 1 trial in prostate cancer, and completed phase 2 studies in lung and head and neck cancers. In addition, the National Cancer Institute (NCI) has sponsored phase 1 studies in lung, ovarian, bladder, and brain cancers as part of its Cooperative Research and Development Agreement (CRADA) with Introgen.

Certain statements in this press release that are not strictly historical may be "forward-looking" statements, which involve risks and uncertainties. Such forward-looking statements include, but are not limited to, those relating to Introgen's future success with its preclinical or clinical development program with its non-viral delivery system or gene therapeutics delivered systemically. 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 quarterly report on Form 10-Q filed on November 13, 2002. 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: .


Introgen Therapeutics, Inc.
C. Channing Burke
(512) 708 9310 Ext. 322

SOURCE Introgen Therapeutics, Inc.

CONTACT: C. Channing Burke of Introgen Therapeutics, Inc.,
+1-512-708-9310, Ext. 322, or
Copyright (C) 2003 PR Newswire. All rights reserved.

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