Generex Announces Podium Presentation on Antigen Express Cancer Vaccine Strategy

WORCESTER, Mass. and TORONTO, Aug. 13, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today announced that Dr. Eric von Hofe, Ph.D., President of its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), will be making a presentation at the Emerging Cancer Immunotherapies and Vaccines conference that is being held as part of the 2013 Immunotherapies Congress in Boston August 13-14.  The conference brings together leaders in both academia and industry, focusing on next-generation targets and strategies for cancer immunotherapy.  Using lessons learned from early cancer vaccines and immunotherapeutics, a new wave of programs are underway that promise improved efficacy and safety over a wider range of cancers.  Emerging Cancer Immunotherapies and Vaccines will examine new targets and strategies in this space, along with important studies in preclinical development associated with developing these programs into successful drug products.

The presentation, entitled 'Augmenting Antigen-Specific CD4+ T Cell Activation in Cancer Immunotherapy', will highlight the significance of activating this particular cell type in the context of immunotherapy strategies designed to inhibit immune suppressive effects.  Examples of this strategy include PD-1 inhibitors and the recently approved CTLA4 inhibitor Yervoy®.

"While some approaches focus on taking the brakes off the immune system in a non-specific way, our strategy with AE37 is to step on the gas to specifically target tumor cells," commented Dr. von Hofe.  A wealth of accumulating evidence from both the clinic and research laboratories underscores the importance of specifically activating CD4+ T cells for effective cancer immunotherapy.

The presentation coincides with a conference call on August 14 featuring members of the Antigen Express Scientific Advisory Board, key opinion leaders who will discuss recent advances in cancer immunotherapy relevant to the positioning of the Antigen Express lead product AE37 as well as the proprietary Ii-Key technology platform upon which it is based.

Antigen Express was founded on a proprietary technology platform capable of generating a robust response against nearly any target one desires the immune system to recognize.  The most advanced compound based on this platform, AE37, is currently in a late Phase II clinical trial to establish efficacy in preventing relapse in patients who have had breast cancer. Results from an interim analysis conducted in October of 2011 were highly encouraging.  Based on those results, the Company has been encouraged to submit a Phase III protocol by the FDA.  Primary efficacy data is anticipated this fall.

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