Generex Announces Publication of AE37 Prostate Cancer Vaccine Study

WORCESTER, Mass. and TORONTO, Aug. 6, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced publication of a follow-up study from a Phase I clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer.  The study demonstrates an association between a specific immune response generated by AE37 and improved overall survival.  The compound is being developed by Antigen Express, Inc. (www.antigenexpress.com), a wholly-owned subsidiary of Generex, for multiple cancer indications.

The publication, entitled, "AE37 peptide vaccination in prostate cancer: identification of biomarkers in the context of prognosis and prediction," appears in the peer-reviewed journal Cancer Immunology, Immunotherapy, a forum for new concepts and advances in basic, translational, and clinical cancer immunology and immunotherapy (online publication July 23, 2014).  While a prior study showed that AE37-immunized patients had better overall and disease-free survival as a group than would be expected from their disease status, the current study shows that patients with the strongest immunological response did the best.  In particular, both the presence of AE37-induced T cells in peripheral blood as well as a robust delayed type hypersensitivity (DTH) response elicited by AE37 correlated significantly with overall survival.  The authors point out the importance of CD4+ T cells in developing a good DTH response.  AE37 was developed using the Antigen Express Ii-Key technology platform that ensures robust, specific CD4+ T cell activation.

The current report expands upon prior studies on the results of a Phase I trial of AE37 in patients with prostate cancer.  AE37 is also the subject of a controlled, randomized Phase II trial to prevent recurrence in patients who have had breast cancer.  That study has shown an encouraging trend toward preventing relapse, particularly in patients with low levels of HER2 expression and in triple negative patients.  The search for reliable biomarkers is a key priority in the emerging field of cancer immunotherapy.  The current study makes important contributions toward that aim while supplying compelling data for the further developmental of AE37.

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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