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Introgen's INGN 241 Effective Against Multiple Cancers in Preclinical Studies

Posted on: Monday, 6 June 2005, 12:00 CDT

ST. LOUIS, June 6 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. reports new preclinical findings on the anti-cancer activity of INGN 241 alone or in combination with a variety of other therapeutic modalities in breast, pancreatic and ovarian cancer cells and as a cancer vaccine. The data were presented at the American Society of Gene Therapy 8th Annual Meeting (ASGT). Conducted with collaborators at The University of Texas M.D. Anderson Cancer Center, the studies show that expression of the mda-7 tumor suppressor gene, the active component of INGN 241, increases cancer cell death and stimulates systemic immunity against cancer. INGN 241 currently is being evaluated in a Phase 2 clinical trial in patients with malignant melanoma.

"The molecular biology of cancer is highly complex and modulating the activity of multiple cancer-related pathways is an essential step toward a cure for this disease," said Sunil Chada, Ph.D., associate vice president, Clinical Research, at Introgen. "The data presented at ASGT highlight the diverse anti-cancer activities of INGN 241 and suggest that this investigational therapy targets several key pathways that impact the development, growth and metastasis of cancer cells. INGN 241 is a key that may unlock many of the molecular doors that today are barriers to effective cancer therapy."

The data were presented in four abstracts. Highlights of the data include:

INGN 241 induces tumor-selective growth inhibition, cell cycle arrest and programmed cell death (apoptosis) in nine breast cancer cell lines, and results in a significant reduction in tumor growth in in vivo models of breast cancer (Abstract #287). These effects are enhanced when INGN 241 is combined with conventional anti-cancer drugs including Tamoxifen(R) (Astra-Zeneca), Taxotere(R) (Sanofi-Aventis), Adriamycin (Bedford Laboratories) and Herceptin(R) (Genentech), or radiation therapy.

Abstract #290 suggests that INGN 241 induces apoptosis and cell killing in ovarian cancer cells but not normal ovarian epithelial cells. Treatment of ovarian cancer cells with INGN 241 and an investigational anti-cancer agent called Vitamin E Succinate, results in enhanced growth inhibition compared with controls or with either agent alone. No significant growth inhibition is observed in normal ovarian epithelial cells.

The next study evaluated the immune activation properties of INGN 241 in animal models with functional immune systems (Abstract #691). Vaccination of mice with tumor cells treated with INGN 241 results in complete protection from tumor growth. Administration of INGN 241 to tumors results in significant inhibition of tumor growth, with a subset of animals showing complete and prolonged tumor regression. The complete tumor regression was not found in mice lacking functional immune systems, indicating that INGN 241 stimulates the immune system to fight cancer.

Treatment of pancreatic cancer cells with INGN 241 leads to cell cycle arrest and apoptosis. This tumor cell killing correlates with down-regulation of proteins in two specific molecular pathways. Additionally, pancreatic cancer cells treated with INGN 241 secrete MDA-7 protein, which kills neighboring cancer cells. This is called a bystander effect. (Abstract #809)

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 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 preclinical or clinical development programs for INGN 241 for the treatment of cancer. 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 not limited to, 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 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 annual report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2005 and its quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2005. 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/ .

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:

Introgen Therapeutics, Inc.

C. Channing Burke

(512) 708 9310 Ext. 322

Email: c.burke@introgen.com

Introgen Therapeutics, Inc.

CONTACT: C. Channing Burke of Introgen Therapeutics, Inc.,+1-512-708-9310, ext. 322, or c.burke@introgen.com

Web site: http://www.introgen.com/

Source: PRNewswire-FirstCall

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