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Generex Subsidiary Antigen Express Announces Publication of Review Showcasing its Proprietary Therapeutic Vaccine Technology in the Journal Vaccine

 

WORCESTER, Mass. and TORONTO, March 14, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) announced today that a review of the Antigen Express proprietary platform technology for generation of immunotherapeutic vaccines has been published in the peer-reviewed journal Vaccine.  The Company is developing therapeutic vaccines for serious unmet medical needs, such as cancer.

The article, entitled "CD4+ T-cell activation for immunotherapy of malignancies using Ii-Key/MHC class II epitope hybrid vaccines", reviews preclinical and clinical studies from the last ten years to the present time demonstrating the importance of generating specific CD4+ T-cell activation in the immunotherapy of cancer.  In addition, the rationale and development of the Company's Ii-Key technology from its discovery in the late 1990's to currently ongoing clinical trials of its lead compound in breast cancer patients is described.

"We are pleased to be able to present our Ii-Key technology in the journal Vaccine," said Dr. Eric von Hofe, President of Antigen Express and senior author of the review. "The technology offers a simple and effective method to potently and specifically increase CD4+ T-cell activation, which on its own is beginning to show signs of clinical efficacy and would certainly augment most other vaccine strategies," he added.

The Company recently released positive interim data from a Phase II efficacy study being performed with its lead Ii-Key compound, AE37, in patients with breast cancer. The study is designed to test for a reduction in relapse in patients who have had standard of care treatment for breast cancer in a controlled and randomized study.

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 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 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.

SOURCE Generex Biotechnology Corporation

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