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6/23/2008 A Shot in the Arm Against Breast Cancer

A breast cancer vaccine currently being tested in a Phase I trial has demonstrated to be safe and well tolerated in breast cancer patients according to a paper to be published in the Journal of Clinical Oncology.

The therapeutic breast cancer vaccine AE37 uses a peptide antigen (immune-stimulating chunk) of a cancer gene known as HER-2/neu. This gene/protein is present in many types of cells, but it is over-expressed in certain types of breast cancer. The vaccine is being developed by Antigen Express, Inc., a wholly owned subsidiary of Generex.

Dr. George Peoples of the Walter Reed Army Medical Center, who presented his findings at this year’s annual meeting of the American Society of Clinical Oncology (ASCO), found the vaccine to be safe and well-tolerated in women whose cancer has not spread to the lymph nodes in the first phase of the study.

In order for therapeutic vaccines to be effective, they must generate a strong response from the immune system to fight off the antigen in the vaccine but also fight off the one present in the cancer.

The AE37 vaccine is based on one of two proprietary platform technologies established at Antigen Express. The technology helps the body fight cancer by modifying fragments of antigens that increase their potency in stimulating the immune system. The vaccine also leaves an imprint to fight the cancer should it ever reoccur.

Key to this vaccine breakthrough is the addition of a peptide molecule that acts as a facilitator to immune system cells and stimulates the desired immune response.

“Think of the vaccine as a Trojan horse: to get the soldiers into the city you put them into a delivery system. Except the ‘horse’ in this case does not really go inside the T-cell,” explains Dr. Peoples. “The vaccine helps the antigen find a ‘receptor’ on the surface of the T-cell so that the immune system, once ignited, will seek out and destroy the cancer.”

“The completion of the trial is a significant milestone,” commented Anna Gluskin, President and Chief Executive Officer of Generex. “While it may be a few years before we bring this to market, entering Phase II trials represents another step closer to the realization of a viable breast cancer vaccine in our lifetime.”

For more information, log on to www.generex.com.

Source: Generex
Contact: Susan Morgenbesser/IRG/212-825-3210

Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or +1-416-364-2551; or Ken Sgro of CEOcast, Inc., 212-732-4300, kensgro@ceocast.com, for Generex Biotechnology Corporation

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