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Generex Biotechnology Begins Testing New Vaccine for Breast Cancer Patients

Posted on: Thursday, 28 April 2005, 09:00 CDT

TORONTO, April 28 /PRNewswire-FirstCall/ -- Generex Biotechnology Corporation , a leader in the area of buccal drug delivery, announced today that the first patients had received a novel therapeutic vaccine developed by its wholly owned subsidiary, Antigen Express as part of the Company's Phase I Trial. The Trial will include between 16 and 24 patients.

The compound, AE37, is designed to stimulate an immune response against the tumor-causing gene HER-2/neu, which occurs in a significant percentage of patients with breast cancer as well as other cancers. A robust immune response against HER-2/neu has the potential to destroy tumor cells even at sites in the body distant from the primary tumor.

Trial Aims at Targeted Immune Response

There are two main distinguishing features of the current trial. The first is that it focuses on developing a specific immune response against a target critical to the growth of tumor cells (HER-2/neu) rather than simply providing non-specific immune stimulation. This is much less likely to produce undesirable side effects than non-specific forms of immunotherapy.

Secondly, AE37 works through a portion of the immune system, represented by the T helper cells, that has been largely overlooked up to now in developing cancer immunotherapy strategies. In recent years, both pre-clinical and clinical studies have shown that stimulation of helper T cells is crucial for generating a robust, long-lasting and effective immune response.

The compound being examined, AE37, is composed of a small piece of the HER-2/neu protein coupled to a portion of the MHC class II-associated invariant chain (Ii protein) shown to greatly enhance stimulation of T helper cells. The discoveries that led to AE37 are based on the work of Dr. Robert Humphreys, founder of Antigen Express, who was first to identify both MHC class II molecules and their role in stimulating T helper cells as well as a portion of the Ii protein capable of dramatically increasing the response of T helper cells to specific antigenic epitopes.

In addition to establishing the safety of AE37, the current trial will establish both the level and longevity of specific T cell stimulation induced by AE37.

Vaccine Is Applicable to Other Major Cancers

While the current trial will involve only patients with breast cancer, AE37 is expected to have equal applicability to other cancers that express HER-2/neu. These include a variety of other major cancers including prostate, ovarian, non-small-cell lung and colon cancer.

This same patented strategy for amplification of T helper response is being employed at Antigen Express for the development of immunotherapies to non-HER-2/neu expressing tumors as well as to viral infections and autoimmune disease. Virtually all infections in which an immune response is capable of playing a curative or ameliorating role are amenable to this strategy for increasing the T helper response. Similarly, autoimmune diseases and allergies in which an unwanted immune response to a known target has been demonstrated are expected to benefit from Antigen Express technologies for modifying the T helper response.

AE37 is being tested with LTC George Peoples, MD, Medical Corps, U.S. Army at the Walter Reed Army Medical Center (WRAMC) in conjunction with the Clinical Breast Care Project (CBCP). The CBCP is a Congressionally mandated civilian-military collaboration between WRAMC, the Uniformed Services University of the Health Sciences (USU), the Windber Research Institute (Windber, PA) and The Henry M Jackson Foundation for the Advancement of Military Medicine, Inc. (Foundation). The mission of the CBCP is to undertake advanced research in breast cancer prevention, diagnosis, and treatment. Antigen Express entered into a Collaborative Research and Development Agreement (CRADA) last fall with the USU and the Foundation to work with Dr. Peoples to advance Antigen Express' HER-2/neu vaccine efforts for breast cancer.

If you would like to be added to Generex's investor email lists please contact Zack Noory with Investor Relations International at znoory@irintl.com.

About Generex

Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), is in late stage clinical trials around the world. Generex acquired Antigen Express in August 2003. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.

Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects,""plans,""intends,""believes,""will,""estimates,""forecasts,""projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Biotechnology Corporation

CONTACT: Shayne Gilliatt of Generex Biotechnology Corporation,1-800-391-6755, or +1-416-364-2551; or Ed Lewis of CEOcast, Inc.,+1-212-732-4300, or elewis@ceocast.com, for Generex Biotechnology Corporation

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

Source: PRNewswire-FirstCall

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