SOURCE: Introgen Therapeutics, Inc.

March 16, 2005 13:45 ET

Introgen's Nanoparticle Formulation of Mda-7/IL-24 Shows Promise in Preclinical Models of Lung Cancer

AUSTIN, TX -- (MARKET WIRE) -- March 16, 2005 -- Data published in a recent issue of DNA and Cell Biology by researchers at Introgen Therapeutics, Inc. (NASDAQ: INGN) and colleagues at The University of Texas M.D. Anderson Cancer Center highlight the potential utility of combining Introgen's nanoparticle delivery system with the mda-7 gene for the treatment of lung cancer. The data reported in the publication are the first to evaluate the anti-cancer effects of delivering the mda-7 gene using the nanoparticle technology.

The delivery system is a component of INGN 401, now in Phase 1 trials for the treatment of lung cancer, and the mda-7 gene is the active component of INGN 241, now in Phase 2 trials for the treatment of metastatic melanoma. A phase 1 clinical study of INGN 241 in various solid tumors has been completed and demonstrated the ability to induce partial or complete regression of injected tumors.

"Systemic gene delivery approaches offer great promise in treating both primary and metastatic cancers. Combining systemic delivery with a clinically relevant potent tumor suppressor is a significant advance," said Sunil Chada, Ph.D., Introgen's director of Research and Development.

The data reported in this publication demonstrate that combining this innovative delivery system with the mda-7 gene results in potent anti-cancer effects and systemic tumor growth inhibition in an animal model of lung cancer. Combining potent anti-cancer genes, such as mda-7 or p53 with the nanoparticle delivery system will allow development of clinical strategies to attack metastatic cancers.

Dr. Rajagopal Ramesh, professor at M.D. Anderson Cancer Center and lead author of the study, continued, "Initial results in our clinical trial of INGN 401, which also is formulated for nanoparticle delivery, are very encouraging, and we have a strong and growing body of preclinical and clinical data supporting the broad anti-cancer effects of mda-7."

In these studies, a specific lipid formulation was combined with the mda-7 gene or control genes to formulate nanoparticles. These nanoparticles were then assessed for their impact on tumor growth, metastasis, vasculature and programmed cell death in mice implanted with human or mouse lung tumors. Lung tumors of both human and murine origin responded to nanopaticle-mda-7 by significant growth inhibition. Tumor inhibition correlated with increased apoptosis and decreased angiogenesis. Furthermore, systemic nanoparticle delivery of mda-7 inhibited metastatic lung tumor growth by up to 80 percent, with no evidence of toxicity.

The mda-7 gene was discovered by the laboratory of Dr. Paul B. Fisher, professor of clinical pathology and the Michael and Stella Chernow Urological Cancer Research Scientist in the Departments of Neurological Surgery, Pathology and Urology at Columbia University. Introgen holds an exclusive worldwide license for all gene therapy applications from the Corixa Corporation.

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.

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 clinical development program for Introgen's nanoparticle formulation delivering the mda-7 tumor suppressor gene. 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: www.introgen.com.

Editor's Note: 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 owns stock in Introgen. These arrangements are managed in accordance with M.D. Anderson's conflict of interest policies.

Contact Information

  • Contact:
    Introgen Therapeutics, Inc.
    C. Channing Burke
    (512) 708 9310 Ext. 322
    Email: c.burke@introgen.com