Generex Announces Interview of MD Anderson's Dr. Elizabeth Mittendorf, Principal Investigator on Company's AE37 Phase IIb Breast Cancer Efficacy Trial

WORCESTER, Mass. and TORONTO, June 12, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced an interview given by Dr. Elizabeth Mittendorf, M.D., Ph.D.  Dr. Mittendorf is the Principal Investigator of the Company's AE37 clinical trial to test the ability of the novel immunotherapeutic agent to prevent relapse in patients who have had HER2-expressing breast cancer, the largest Phase IIb peptide clinical trial conducted to date.  AE37 is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).  The interview was conducted by Oncology TV at this year's Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago from May 31 to June 4.  The interview can be viewed online at:

http://www.oncology.tv/Videos/TabId/79/VideoId/474/ASCO-2013-Elizabeth-A-Mittendorf-MD-PhD-HER2-Peptide-Vaccine.aspx

The interview of Dr. Mittendorf, Assistant Professor, Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, gave an overview of this year's ASCO presentations on AE37, as well as where the breast cancer vaccine fits into the field of cancer immunotherapy.  She noted that cancer immunotherapy in general was much more in the limelight at this year's conference.  She described the two distinguishing features of AE37 that set it apart from other types of cancer vaccines.  Firstly, the vaccine is designed to stimulate CD4+ T helper cells, which are key in generating a more  robust anti-tumor immune response.  Secondly, the vaccine includes a proprietary modification that increases its potency.  The studies that were part of this year's ASCO meeting confirm these unique properties.  Dr. Mittendorf was also noted that this vaccine addresses patients with any level of HER2 expression, unlike other HER2-targeted therapies.  Currently, patients with low HER2 expression represent a patient population of significant unmet need (representing 50% of all breast cancers). 

The updates this year built upon interim results of the Company's controlled, randomized Phase IIb clinical trial of AE37 presented at last year's ASCO meeting.  Those presentations demonstrated a clear trend toward reduced relapse in breast cancer patients who had received AE37.  One of the studies this year showed that while some patients developed a hypersensitivity reaction (urticarial response), they appeared to have a stronger all-around immune response to the AE37 vaccine.  Interestingly, no relapses have been observed in this population of patients.  A second presentation demonstrated that repeated AE37 boosters could be safely given to patients to further augment and extend the initial anti-tumor immune response observed with AE37.

The primary efficacy analysis of Phase IIb data from the Antigen Express breast cancer study is expected prior to the end of 2013.  Mark Fletcher, Generex President & Chief Executive Officer, commented: "Based on the outstanding interim results announced at ASCO 2012, we are looking forward to qualitatively similar results with greater statistical robustness when data is evaluated later this year, which will leave Antigen Express well-positioned to secure a partnership for a Phase III trial."  Antigen Express has been encouraged by the US Food and Drug Administration to submit a protocol for the Phase III trial, which the Company is in the process of preparing under the auspices of a Special Protocol Assessment (SPA), whereby the FDA declares the design, clinical endpoints, and statistical analyses acceptable for FDA approval.

Finally, Dr. Mittendorf pointed to the possible real benefit of combining AE37 with other agents, such as immune checkpoint inhibitors.  In particular, inhibitors of PD-1 (programmed cell death protein 1) or CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) have been shown to essentially take the brakes off the immune system, allowing it to more effectively combat tumor cells in a general way.  As AE37 activates the immune system to specifically attack tumor cells, essentially "stepping on the gas", it is an exciting hypothesis to try combining them.  It should be noted, however, that patients treated with AE37 alone also appear to have "taken the brakes off" the immune system to an extent.

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