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Generex Points to Potential of Antigen Express Technology Platform beyond Its AE37 Breast Cancer Vaccine
Date:1/31/2013

WORCESTER, Mass. and TORONTO, Jan. 31, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today explained the potential of the technology platform used as the basis for its novel breast cancer immunotherapy product AE37. AE37 is currently in late Phase IIb clinical development and has garnered considerable attention based upon favourable results from interim analysis of its controlled, randomized, and blinded trial in women with early stage breast cancer.

The main potential advantage cancer immunotherapy like AE37 has compared to other cancer therapies is the ability to direct the body's immune system against targeted cancer cells, similar to other vaccines that direct the immune system against targeted infections. Obviously, the difficulty in treating cancer this way is that it arises from our own tissues rather than from an outside organism. It requires extra coaxing for the immune system to recognize and attack cancer cells that are similar (relatively on the surface) to a person's normal cells. The proprietary modification that is incorporated into AE37, termed Ii-Key, is what gives AE37 the added potency required to activate and direct the immune system to go after cancer cells. The 'payload' in AE37 is a fragment protein associated with cancer cells, best known in breast cancer, but also known for its occurrence in other cancers, called HER2.

The addition of a protein called Ii-Key, the Antigen Express proprietary technology, to the HER2 fragment ensures that the HER2 target is recognized as the protein to attack by immune cells; additionally, the technology adds the HER2 protein to the immune system memory for future reference. The key activated immune cells, termed CD4+ T helper cells, in a sense represent the Generals of the immune system, controlling and directing the immune system to target key proteins. The process of activating CD4+ T helper cells requires intracellular processing through processing cells called 'antigen presenting cells'. For example, in infections or cancer, to get the immune Generals, CD4 cells, to attach to a virus or bacteria or cancer, the antigen processing cells will engulf and degrade the virus or bacteria or cancer cell. Ii-Key bypasses the need for intracellular cell degradation and processing, ensuring any payload attached to the Ii key protein will be delivered directly for activation of the immune Generals, CD4+ T cells. In this way, Antigen Express technology essentially hijacks the immune system into going after any given target.

Antigen Express has explored the uses of Ii-Key to deliver a variety of 'payloads' to activate the immune system, both to prove the technology and develop a pipeline. Ii-Key-based lead compounds have been identified for the HER2 protein, being researched in early breast cancer and also proteins in cervical cancer (HPV) and melanoma. The studies describing the activity and preclinical development of those compounds are the subject of peer-reviewed publications. The Company is thus on track to deliver on its business development strategy of demonstrating Phase IIb proof of principle of products in early breast cancer for partnering or licensing as well as offering a proven technology platform for the development of further immune therapy product candidates by potentially adding immune target proteins selected by outside parties to our proprietary Ii key platform.

About Generex Biotechnology Corporation

Generex is engaged in the research, development, and commercialization 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™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of 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," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" 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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.


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SOURCE Generex Biotechnology Corporation
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