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Generex Biotechnology Corporation (GNBT) Touts Pipeline Potential of Antigen Express, Inc. (GNBT) Subsidiary


2/7/2013 10:24:35 AM

WORCESTER, Mass. and TORONTO, Feb. 7, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today provided an overview of the current pipeline and potential of its wholly-owned subsidiary Antigen Express, Inc. (www.antigenexpress.com). While the Company is currently in a late Phase IIb trial of a very promising new immunotherapy for early breast cancer (AE37), the Company has made concrete headway in demonstrating a robust pipeline for AE37 indications beyond breast cancer, as well as for the technology behind it. Immediately behind its Phase III-ready breast cancer program, the Company has completed a Phase I prostate cancer trial and established a protocol for Phase II. While Herceptin targets the same tumor-associated protein as does AE37 therapy, Herceptin is not approved for breast cancer patients with low levels of HER2 expression, limiting Herceptin treatment to roughly 25% of breast cancer patients. Low levels of HER2 protein have been shown on several cancers, including men with prostate cancer. AE37 is being further researched in this larger population of patients whose tumors express only low levels of HER2.

(Logo: http://photos.prnewswire.com/prnh/20110106/NY25057LOGO-b)

While breast and prostate cancers are the initial indications being investigated for AE37, nearly all cancers of the gastrointestinal tract as well as lung,ovarian, bladder,and other cancers also express low levels of HER2. AE37 future research may help establish its role in many cancers in addition to breast and prostate cancer. A unique aspect of Antigen Express technology, which has enabled the promising results obtained so far from the AE37 Phase IIb trial in early breast cancer, is the Ii-Key technology platform. This technology enhances delivery of key target proteins like HER2 for cancer to a critical immune recognition site enhancing immune recognition. The Company has also developed compounds designed for important non-HER2 cancer associated protein targets using the Ii-Key technology platform. These include the melanoma-associated gp100 target, as well as cervical and head-and-neck cancers associated with Human Papilloma Virus (HPV). These compounds have shown significant activity in animal models that has been described in peer-reviewed publications.

In addition to cancer protein targets, the Company has clinically tested Ii-Key-based proteins designed to protect against the potentially pandemic influenza strains H5N1 (avian flu) and H1N1 (swine flu). The advantage here is that the Antigen vaccine technology is entirely synthetic, making it simple to manufacture. In the event of a potentially pandemic influenza virus, there is clearly a need for this type of flexible vaccine technology that can be brought into production rapidly.

The distinguishing feature of Antigen Express technology (Ii-Key) is the ability to activate critical components of the immune system (CD4+ T helper cells) in a robust and specific manner. Currently this is a unique technology platform that directs proteins to a critical immune component to be able to create specific immune stimulation. This Ii-Key technology is proprietary to Antigen Express. Consequently, the Company is in a good position to license the technology for combination with multiple different target proteins to create novel vaccine applications that may be of interest to other researchers and companies.

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.

SOURCE Generex Biotechnology Corporation


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