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Generex Subsidiary Antigen Express Featured on SNN Stock News Now; Highlights Advantages of Ii-Key Platform Technology for Cancer Immunotherapy
Date:1/17/2012

WORCESTER, Mass. and TORONTO, Jan. 17, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT.OB) announced today that a detailed interview conducted at the BioTech Showcase 2012 during last week's JPMorgan Healthcare Conference in San Francisco with Dr. Eric von Hofe, Ph.D., President of Generex subsidiary Antigen Express, Inc., regarding the Antigen Express breast cancer vaccine, is available on the Stock News Now website (www.stocknewsnow.com) and on the Generex website (www.generex.com).

The company further outlined advantages of the Ii-Key immunotherapeutic vaccine. This comes in the wake of positive interim data from its Phase 2b breast cancer trial announced last month at the San Antonio Breast Cancer Symposium.

One of the core platform technologies of Antigen Express was obtained through seminal discoveries by the founder of the company, Dr. Robert Humphries. As one of the first to characterize MHC class II molecules, he spent a large part of his career elucidating the mechanism of antigenic peptide charging of MHC class II molecules and presentation to CD4+ T helper cells. In particular, he showed that a portion of an MHC class II cofactor controlled antigenic peptide loading onto the class II molecule. It was immediately clear that this represented a simple yet highly effective means of controlling the activation of CD4+ T cells.

Ii-Key, as this portion of the MHC class II cofactor was termed, provides a robust means for causing MHC class II molecules to either spill antigens causing a harmful autoimmune responses (such as in multiple sclerosis, rheumatoid arthritis or Type I diabetes) or, when linked to an antigen, an activating response triggering a potent immune response. For this latter application, Ii-Key has been linked to a variety of antigens (e.g., portions of viral proteins or proteins expressed in cancer cells) to produce a more robust yet specific activating immune response.  Broad patent protection has been allowed for the various functional activities of Ii-Key.

The most advanced Ii-Key compound currently under development is AE37, which contains a portion of the tumor-associated HER2 protein linked to Ii-Key. In a number of preclinical studies, AE37 has shown clearly increased potency over the unmodified HER2 peptide, consistent with the increased activity of a variety of other Ii-Key containing peptides that have been investigated.  Of perhaps greatest interest is the observation that AE37 produced a robust and specific immunological response in a Phase I trial in the absence of immunological adjuvant. This is in clear contrast to most other peptide vaccines that are being developed.

The recently reported interim results of a randomized, controlled Phase 2b trial showing a strong trend toward decreased relapse in patients receiving AE37 is consistent both with the increased immunological activity of AE37 as well as a variety of studies in the field of cancer immunotherapy showing the importance of specific CD4+ T helper cell activation in generating an effective anti-cancer immune response.  While the anti-HER2 therapeutic Herceptin has been shown to significantly reduce relapse in breast cancer patients, it can only be used in roughly 25% of patients whose tumors express the highest level of the HER2 protein.  AE37, in contrast, is applicable for use in patients whose tumors express lower levels of HER2.  This population, which is ineligible for Herceptin, represents approximately 50% of breast cancer patients.

About AE37 and Ii-Key Hybrid Platform Technology

Antigen Express is a platform technology and product-based company developing proprietary vaccine formulations for large, unmet medical needs. The Company's Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells. Incorporating the Ii-Key modification along with tumor-associated antigens can greatly enhance the immune system's ability to recognize and destroy cancer cells bearing any of the targeted antigens as well as increasing immunological memory.

The first product candidate utilizing the Company's novel Ii-Key Hybrid technology platform is a HER-2/neu Peptide Vaccine (AE37). This "off-the-shelf" cancer immunotherapy product candidate is easier and less costly to produce than comparable cell-based approaches. AE37 is derived from a peptide fragment of the human epidermal growth factor receptor 2 (HER2) oncoprotein, which is expressed in a variety of tumors including 75-80% of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide.

About Breast Cancer

According to the American Cancer Society, more than 232,000 women will be diagnosed with breast cancer, and nearly 40,000 will die from the disease, in 2011.  For women whose cancer tests positive for increased quantities of the HER2, approved targeted therapies include trastuzumab (Herceptin®; Roche-Genentech). However, only 25% of breast cancer patients have HER2 levels high enough to be eligible for Herceptin.  AE37 is positioned initially as an adjuvant therapy for at least 50% of breast cancer patients; i.e., those with low-to-intermediate levels of HER2 expression.

About Generex Biotechnology Corporation

Generex, the parent company of Antigen Express, is also 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 in immunotherapy. One of its platform technologies 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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