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Generex Subsidiary Antigen Express Provides Update on Phase 2 Breast Cancer Immunotherapy Program

WORCESTER, Mass. and TORONTO, Aug. 18, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) ( announced today that the Company's wholly-owned subsidiary Antigen Express, Inc. ( presented an update of the ongoing Phase 2 trial with an off-the-shelf immunotherapeutic cancer vaccine, AE37, in patients with breast cancer at Cambridge Healthtech Institute's Sixth Annual ImVacS: The Immunotherapeutics and Vaccine Summit held August 16-18, 2011 in Cambridge, MA.

In a presentation titled Clinical Development of a Modified, Self-Potentiating HER2 Peptide Vaccine in Breast and Prostate Cancer Patients, Dr. Eric von Hofe, Ph.D., President of Antigen Express, presented positive preliminary results from an ongoing Phase 2 trial of AE37 in breast cancer patients.  At a median of 17 months follow-up, the relapse rate in patients with low levels of HER2 expression treated with AE37 is half that of the same patient population in the control arm.  The primary endpoint of the study is to demonstrate a significant reduction in relapse rate in AE37 patients after 24 months follow-up.

The Company has also concluded a Phase I trial in patients with prostate cancer.  All trials conducted to date have shown that AE37 is safe, well-tolerated, and induces the desired immune response.  

About AE37

Antigen Express' novel Ii-Key Hybrid Preventive HER-2/neu Peptide Vaccine (AE37) is an "off-the-shelf" cancer immunotherapy product candidate that is easier and less costly to produce than comparable cell-based approaches.  AE37 is derived from a fragment of the HER2 oncoprotein, which is over-expressed in a variety of tumors, including breast, ovarian, prostate, colon, and lung tumors.  AE37 is positioned as an adjuvant therapy for at least 50% of breast cancer patients with low-to-intermediate levels of HER-2 expression that are not eligible for treatment with trastuzumab (Herceptin®).  Only 25% of breast cancer patients have HER-2 levels high enough to be eligible for Herceptin.

A controlled, randomized, and single-blinded Phase II clinical study of AE37 in HER-2 expressing breast cancer patients is currently underway to establish clinical efficacy.  The study endpoint is a reduction in cancer relapse after two years compared to the current standard of care treatment.  There are currently over 200 patients enrolled in the study with either node positive or high-risk node-negative breast cancer.  While positive preliminary results suggested that statistically definitive results may be obtained in 2012, the company opted to enroll an additional 100 patients early in 2011 to ensure sufficient patient numbers.  In particular, these additional patients are required to have low HER-2 expression levels such that they are not eligible for Herceptin.  It is anticipated that a planned Phase 3 trial will be conducted in this specific patient population.

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 in immunotherapy.  One of its platform technologies 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
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