Generex Announces ASCO Presentations on the Antigen Express Advanced Stage AE37 Cancer Vaccine Studies show superiority of AE37 among peptide cancer vaccines

WORCESTER, Mass. and TORONTO, May 22, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today announced three presentations demonstrating the superiority of the AE37 breast cancer vaccine being developed by its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The presentations will be made at the annual meeting of the American Society of Clinical Oncology (ASCO) to be held in Chicago from May 31 through June 4, 2013.

The presentation entitled "Booster inoculations of the AE37 peptide vaccine enhance immunological responses in a phase II study", by Eleftheria Anastasopoulou et al, demonstrates that increased immunological responses observed after the initial series of inoculations with AE37 can be further increased over a 24 month period in patients receiving boosters every six months.  The AE37 vaccine is a combination of a fragment of the HER2 protein plus a proprietary modification developed by Antigen Express scientists.

The presentation entitled "Risk factors for development of delayed urticarial reactions in the phase II trial of HER2 peptide vaccines plus GM-CSF versus GM-CSF alone in high-risk breast cancer patients to prevent recurrence", by Alfred Trappey et al, demonstrates that the only side effects are associated with the GM-CSF adjuvant rather than the AE37 peptide and are entirely manageable.

A third online abstract 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, demonstrates long-term immunological response to AE37 in prostate cancer patients in the absence of booster administration.  Two measures of an elevated, specific immune response were statistically unchanged even three years after the initial treatment regimen.  This period is longer than reported for any prior peptide vaccine.

Taken together, these three studies demonstrate that AE37 is meeting or exceeding all expectations for generating a specific, robust and long-lived immune response while maintaining a favorable safety profile.  Interim results from the controlled, randomized and single-blinded Phase II trial in patients who have had breast cancer show a strong trend toward decreased relapse in patients who have received the vaccine.

The primary efficacy analysis of Phase II data from the breast cancer study is expected prior to the end of 2013.  Mark Fletcher, Generex President & Chief Executive Officer, commented:  "Based on the outstanding interim results announced at ASCO 2012, we are looking forward to qualitatively similar results with greater statistical robustness when data are evaluated later this year, which will leave Antigen Express well-positioned to secure a partnership for a Phase III trial."  Antigen Express has been encouraged by the US Food and Drug Administration to submit a protocol for the Phase III trial, which the Company is in the process of preparing under the auspices of a Special Protocol Assessment (SPA), whereby the FDA declares the design, clinical endpoints, and statistical analyses acceptable for FDA approval.

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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