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Positive Generex Data Underscores Cancer Immunotherapy Forecast Issued by Citi

May 31, 2013

Studies Submitted to ASCO Demonstrate Immunogenic Superiority of AE37 Over All Other Peptide Cancer Vaccines

WORCESTER, Mass. and TORONTO, May 31, 2013 /PRNewswire/ — Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today highlighted advantages of its AE37 cancer vaccine and technology in the context of a positive cancer immunotherapy forecast recently issued by Citigroup analysts. The Company’s wholly-owned subsidiary Antigen Express, Inc. (www.antigenexpress.com) is currently in a late Phase IIb trial of the novel cancer vaccine AE37 to prevent relapse in patients who have had breast cancer.

According to Reuters, in a report issued on May 22, 2013, Andrew Baum, head of global healthcare research at investment bank Citi, forecasts that in a decade immunotherapy cancer drugs will be treating 60% of cancers and generate annual sales of up to $35 billion. This analysis marks a considerable increase over prior market forecasts and highlights cancer immunotherapy as the next “big thing” in biopharma research, surpassing sales of the blockbuster drug class of statins.

Among the Antigen Express data to be part of the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO), an abstract was published online entitled “Effect of immunization with Ii-Key modified HER2 (776-790) peptide vaccine (AE37) on immunologic responses in prostate cancer patients“, by Sonia Perez et al. Of particular note was the longevity of the immunological response to AE37 in immunized patients. In this study, an elevated and specific immunological response was still observed three years after the final dose of AE37. No other peptide vaccine in either early or late-stage development has been shown to exhibit this type of long-lasting activity.

The most plausible explanation for this increased activity is the fact that AE37 is specifically designed by proprietary technologies to augment T helper cell activity, a type of immune cell associated with long-term memory responses. Antigen Express was founded on a technology platform whereby nearly any tumor-associated antigen can be modified to more potently stimulate T helper cells without sacrificing the specificity of the immune response. AE37 is currently the subject of a controlled, randomized and single-blind Phase IIb trial to test its ability to prevent relapse in patients who have had breast cancer. A planned interim analysis in October of 2011 was highly encouraging, showing a strong trend toward reduced recurrence in patients given AE37. While the latest published report from patients with prostate cancer was not designed to test efficacy, it was of interest that an increase of > 200 % in PSA-doubling time was noted in 6/17 patients, with three retaining this effect to five years.

This study, together with other published studies, indicates that the AE37 vaccine is meeting or exceeding the Company’s expectations for the generation of a specific, robust, and long-lived immune response while maintaining a favourable safety profile. Interim results (October, 2011, reported at ASCO’s Annual Meeting in 2012) from the Phase IIb trial in patients who have had breast cancer show a strong trend toward decreased rate of relapse in vaccinated patients. A primary efficacy analysis of the Phase IIb data is expected before the end of 2013.

Mark Fletcher, Generex President & Chief Executive Officer, commented: “According to the National Cancer Institute, 232,340 new diagnoses of breast cancer are estimated in 2013. Of those patients, approximately one quarter will be HER2 positive and another 50% will exhibit low HER2 expression. AE37 is being positioned to target those patients who have low HER2 expression and achieve remission with current standards of care but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status. We currently predict that our Phase IIb trial will hit its primary efficacy endpoint to show improved disease-free survival (DFS) before the end of this year. Based on our previous interim analysis, the US Food and Drug Administration has encouraged us to submit a Phase III protocol, which is being prepared as part of a Special Protocol Assessment (SPA). The Phase III trial will assess prevention of recurrence in node-positive and high risk node-negative breast cancer patients with low HER2 expression.”

Dr. Eric von Hofe, PhD, President of Antigen Express, stated: “While the advent of Herceptin and a variety of other HER2-targeted therapies represent significant advances in breast cancer therapy, patients with low HER2 expression are ineligible for those types of therapy. The AE37 mechanism of action will permit that larger population of low HER2 patients to be addressed. The encouraging AE37 efficacy data presented at the 2012 ASCO meeting, as well as the corroborating data being presented this year, suggest that there may now be hope for those patients excluded from traditional HER2-targeted therapies.”

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(TM) 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


Source: PR Newswire