Generex Announces Publication of Comparative Peptide Vaccine Studies in Peer Review Journal Demonstrating Superiority of AE37 and Presentation at the American Association for Cancer Research

WORCESTER, Mass. and TORONTO, April 4, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) announced today the publication of a report comparing the clinical characteristics of three different immunotherapeutic peptide vaccines designed for immunotherapy of breast cancer.  One of those, AE37, is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).

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The AE37 peptide, which is modified by proprietary technology to increase specific immunity against the HER2 protein expressed on cancer cells, is currently the subject of a randomized and controlled Phase II trial in patients with breast cancer as well as a Phase I trial in patients with prostate cancer that was recently completed.  

The report, entitled "Comparison of different HER2/neu vaccines in adjuvant breast cancer trials: implications for dosing of peptide vaccines", appeared in the February issue of Expert Review of Vaccines.  The three peptides compared were AE37, E75 (also known as NeuVax™) and GP2.  Both E75 and GP2 represent unmodified peptides derived from the HER2 protein selected to stimulate cytotoxic CD8+ T cells.  

In contrast, AE37 is a modified HER2-derived peptide designed to stimulate CD4+ T helper cells (in addition to CD8+ T cells).  All peptides were shown to be safe and well tolerated by breast cancer patients.  The order of potency of specific HER2 immunity induced by the peptides was: AE37 followed by GP2 followed by E75.  Though not yet confirmed, there is evidence suggesting that a better immunological response against HER2 is associated with decreased disease recurrence and mortality.

A further study is being presented at the 102nd Annual Meeting of the American Association for Cancer Research (www.aacr.org) being held in Orlando, FL from April 2 through April 6.  That study, entitled "Circulating regulatory T cells (CD4⁺CD25[high] CD127[low]) decrease in breast cancer patients after vaccination with a modified HER-2/neu HLA class II peptide (AE37) vaccine", will be presented April 5.  The study shows that a subgroup of CD4+ cells that have the potential to suppress immune responses, termed T regulatory cells, actually decrease after immunization with AE37.  This decrease in T regulatory cells was not observed in patients immunized with GP2.

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.  The Company's buccal insulin spray product, Generex Oral-lyn™ is in Phase III clinical trials at several sites around the world.  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.

Safe Harbor Statement

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," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," 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