Generex Announces Presentation of New Immune Response Data from AE37 Phase II Breast Cancer Trial at ASCO 2012

Generex Announces Presentation of New Immune Response Data from AE37 Phase II Breast Cancer Trial at ASCO 2012

WORCESTER, Mass. and TORONTO, June 5, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT.OB) announced today that new immune response data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine undertaken by Generex wholly-owned subsidiary Antigen Express, Inc. was presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) ( on June 2, 2012 in Chicago, IL.

The abstract entitled: 'An assessment of disease features and immune response in breast cancer patients that did not recur after receiving HER2 peptide, AE37 vaccine in a randomized phase II trial' by Diane Hale, et al, was presented June 2 in the Breast Cancer — HER2/ER session at ASCO. The presentation compared the immunological response in patients who relapsed versus those who did not.  The parameters examined included T cell proliferation and cytokine expression, delayed-type hypersensitivity (DTH) and presence of T regulatory cells.

While all AE37 immunized patients showed increased T cell activation, DTH response and a decrease of T regulatory cells, the strongest predictive association with disease free survival appeared to be a decrease in T regulatory cells, which function to limit the immune response. This is of particular interest given that the AE37 peptide is designed to specifically activate CD4+ T helper cells. An early concern was that T regulatory cells (which are a subset of CD4+ T cells) might also be increased. Their decrease after AE37 immunization has been observed in two Phase I clinical trials as well as in the ongoing Phase II study.

The study confirms prior observations that AE37 has multiple mechanisms of action in generating an anti-cancer immune response, activating T cells to specifically recognize tumor cells while reducing inhibitory immunological responses.  The study, together with interim results showing a trend toward decreased relapse in breast cancer patients receiving AE37, supports advancement to Phase III clinical trials.

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 or the Antigen Express website at

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