• 12/9/2004
  • San Antonio, TX
  • Press Release
  • prnewswire.com

Introgen Therapeutics, Inc. reported data from its Phase 2 trial evaluating Advexin combined with neoadjuvant chemotherapy in women with locally advanced breast cancer. 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. Objective clinical responses with a greater than 50 percent reduction in tumor size were seen following the combined therapy in all of the patients. 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. 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 known to participate in immune responses against tumors, which may be useful in controlling local
disease as well as disease outside the breast.

Introgen’s collaborator, Dr. Massimo Cristofanilli, associate professor in the Department of Breast Medical Oncology at M. D. Anderson Cancer Center presented the data yesterday afternoon at the 27th Annual San Antonio Breast Cancer Symposium.

Key findings of the study include:
— On average, tumor size decreased by nearly 80 percent.
— On average, size of lymph node tumors decreased by nearly
70 percent.
— Advexin-expressed p53 was detectable up to 19 days following
administration in a 21-day treatment regimen.
— Advexin was very well tolerated.

Dr. Cristofanilli commented, “The p53 tumor suppressor, the active component of ADVEXIN, has been shown to sensitize cancer cells to the effects of chemotherapy. The results of this study suggest that tumors treated with ADVEXIN and chemotherapy had a greater reduction in size compared to what would be expected with chemotherapy treatment alone. The observation of an infiltrating T-cell immune response suggests that ADVEXIN may also work through additional immune mechanisms of action to eradicate tumor cells.

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.

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 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 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.

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.