Encouraging Results Of Introgen Therapeutics, Inc.'s ADVEXIN Breast Cancer Treatment Updated

AUSTIN, Texas, Dec. 8 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. today reported an update of data from its Phase 2 trial evaluating ADVEXIN(R) combined with neoadjuvant chemotherapy and surgery in women with locally advanced breast cancer. Currently, after 35 months of follow-up, 92 percent of the treated patients are alive and 83 percent have survived without evidence of disease recurrence. Objective clinical responses were seen following the combined therapy in all of the patients with a median of 80 percent reduction in tumor size. Following tumor shrinkage, complete tumor removal by subsequent surgery was achieved in 100 percent of the patients. The results of the therapy with the addition of ADVEXIN are better than what would be expected from neoadjuvant chemotherapy treatment alone.

Neoadjuvant treatments are administered prior to surgery and represent a novel and increasingly applied approach to make surgical tumor resections either more complete improving outcomes or less invasive facilitating breast conservation.

Dr. Kerstin Menander, Introgen’s vice president of Clinical Development said, “These data are very encouraging, and suggest that ADVEXIN may be combined with neoadjuvant chemotherapy to improve patient outcomes by reducing tumor size thereby permitting complete surgical tumor removal. The results of this study indicate that ADVEXIN may enhance the clinical benefit of chemotherapies without increasing their toxicity and support clinical applications of ADVEXIN in earlier phases of cancer treatment.”

In a novel finding, activation of a local immune response at the site of the tumor was observed. Treated tumors were infiltrated with cells of the immune system that are associated with immune responses against tumors, which may be useful in controlling local disease as well as disease outside the breast.

Earlier data from this ADVEXIN study were initially reported at the San Antonio Breast Cancer Symposium (SABCS) in 2004, and the update is being reported in conjunction with the presentation of data from additional Introgen studies for breast cancer treatment at SABCS 2005.

Dr. Menander continued, “These results are entirely consistent with the known mechanism of action of p53 protein, the tumor suppressor protein delivered by ADVEXIN. p53 normally controls the expression of hundreds of genes many of which have anti-tumor effects. The functions mediated by ADVEXIN p53 therapy include the suppression of tumor growth, the induction of tumor cell death, inhibition of angiogenesis, and stimulation of anti-tumor immunity. Our preclinical and clinical studies have demonstrated these same mechanisms of action for ADVEXIN. The ability of p53 to induce tumor cell death is increased in the presence of DNA damage caused by standard cancer chemotherapy and radiation treatments. A large body of preclinical and clinical data suggests that ADVEXIN interacts synergistically with many standard anti-cancer therapies and we are not surprised that the combination of ADVEXIN with chemotherapy in these patients is generating encouraging results.”

About ADVEXIN

There are two multi-national, multi-site Phase 3 trials of ADVEXIN therapy, currently underway in recurrent squamous cell cancer of the head and neck. Introgen has received FDA Fast Track designation for ADVEXIN therapy and ADVEXIN has been designated as an Orphan Drug for the treatment of head and neck cancer under the Orphan Drug Act. In December of 2004, Introgen initiated the registration process for ADVEXIN by submitting to the US Food and Drug Administration a Request for a rolling Biologic License Application.

ADVEXIN has been evaluated in a variety of cancer types and in combination with several standard cancer therapies, including radiation and chemotherapy. Data from several published preclinical and clinical studies have demonstrated the ability of ADVEXIN to safely enhance the anti-cancer effects of radiation and chemotherapy treatment.

ADVEXIN supplies p53 protein in very high concentrations in cancer tissue and selectively kills cancer cells. p53, known as the “Guardian of the Genome”, is a normal constituent of cells and is known as a tumor suppressor because it inhibits the growth of tumor cells. One of the major roles of this protein is to eliminate cancerous cells by recognizing when the cell has been damaged by mutations and stopping cell growth to initiate repair. If the cell is damaged beyond repair, p53 initiates the cell death pathway to prevent the cell from growing out of control.

About Introgen

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 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.

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.

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 ADVEXIN in the treatment of breast cancer. 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: c.burke@introgen.com

Introgen Therapeutics, Inc.

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

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