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Generex Announces Presentation of Primary Efficacy Data & Immunological Response from the Phase II Study of AE37 Cancer Vaccine at ASCO

PR Newswire

WORCESTER, Mass. and TORONTO, May 20, 2014

WORCESTER, Mass. and TORONTO, May 20, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced two upcoming presentations demonstrating that certain patients with early stage breast cancer who receive AE37 may benefit in terms of reduced risk of relapse.  The AE37 breast cancer vaccine is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The presentations will be made at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held in Chicago from May 30 through June 3, 2014.

The Company recently reported completion of accrual to a prospective, randomized, controlled and single-blinded Phase II study of AE37 in newly diagnosed breast cancer patients. Prior interim analysis revealed a strong trend toward reduction of relapse in patients with low to intermediate levels of HER2 expression.

AE37 was designed to generate a robust response to the HER2 protein, particularly in CD4+ T helper cells, which have been shown to be critical in the generation of a new immune response. The results of two Phase I studies, in breast and prostate cancer patients respectively, previously demonstrated robust and specific immune stimulation. AE37 has been shown to be safe and well-tolerated by patients in all trials.

The first presentation entitled "Primary analysis of the prospective, randomized, single-blinded phase II trial of AE37 vaccine vs GM-CSF alone administered in the adjuvant setting to high risk breast cancer patients" by Mittendorf et al, demonstrates that patients with low to intermediate levels of HER2 expression displayed a trend toward benefit from the AE37 vaccine, as was initially observed from the interim analysis of the same study. In particular, patients with triple negative breast cancer appeared to derive the greatest benefit. Patients in the low HER2 group exhibited a 40% decrease in the risk of relapse (p=0.21) while those with triple negative cancer exhibited a 60% decreased risk (p=0.12).

The second presentation, entitled "Immunogenic Comparison of Recurrent and Non-Recurrent Breast Cancer Patients Undergoing AE37 Peptide Vaccine Therapy" by Schnebel et al, showed a correlation between the magnitude of immunological response to AE37 and the tendency to relapse. Prior studies have shown that AE37 generates a more robust immune response than other HER2 targeted peptide vaccines, with AE37 being the only vaccine capable of generating a specific immunogenicity in the absence of GM-CSF adjuvant.

"We remain encouraged by the overall AE37 clinical data package" said Dr. Eric von Hofe, Ph.D., President of Antigen Express. "The robustness of the immunological response, together with a trend toward reduced relapse in patients with low HER2 expression, and particularly those with triple-negative breast cancer, is promising," he continued. The lack of effective treatments for triple negative breast cancer patients has long been recognized as a major area of unmet medical need.

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