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Generex Points To Potential Of Antigen Express Technology Platform Beyond Its AE37 Breast Cancer Vaccine

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.

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