Generex Announces Presentation at the Society for Immunotherapy of Cancer Demonstrating that Induction of Antibody Response in Patients Receiving the AE37 Breast Cancer Vaccine Correlates with Reduced Relapse

WORCESTER, Mass. and TORONTO, Nov. 11, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced a presentation showing that induction of an antibody response to the HER2 target of its AE37 cancer vaccine correlated with a reduction of relapse in breast cancer patients. The AE37 cancer vaccine is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The presentation was part of the 29^th Annual Meeting & Associated Programs of the Society for Immunotherapy of Cancer (SITC) (www.sitcancer.org) that was held November 6-9, 2014 in National Harbor, MD.

The presentation, entitled "Correlation of HER2/neu antibody response to clinical response in a phase II trial of the AE37+GM-CSF HER2 peptide vaccine" by Greene et al, further expands the evidence showing that the immunological response generated by the Company's novel cancer immunotherapeutic correlates with effectiveness. In particular, the study showed that the level of induction of the antibody response rather than absolute levels of HER2-specific antibodies was higher in patients who did not relapse.

While cellular immune responses have been consistently demonstrated in clinical trials of AE37, this is the first study to characterize the generation of HER2-specific antibody responses elicited by the AE37 vaccine. The AE37 cancer vaccine was designed to specifically activate HER2-specific CD4+ T cells. This cell type is important both in the induction of both cellular and antibody immune responses. In addition to the induction of HER2-specific CD4+ T cells, CD8+ cytotoxic T lymphocytes induction also been shown in immunized patients. Interestingly, a reduction of immune suppressive T regulatory cells has also been consistently shown in AE37 immunized patients.

SITC is a medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Currently, SITC has more than 800 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer.  Through emphasis on high-caliber scientific meetings, dedication to education and outreach activities, focus on initiatives of major importance to the field, and commitment to collaborations with like-minded organizations and patient advocacy groups, SITC brings together all aspects of the cancer immunology and immunotherapy community in an effort to make cancer immunotherapy one of the four standards of care and the word "cure" a reality for cancer patients living with this disease.

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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