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Generex Announces Interview of MD Anderson's Dr. Elizabeth Mittendorf, Principal Investigator on Company's AE37 Phase IIb Breast Cancer Efficacy Trial
Date:6/12/2013

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 dec
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SOURCE Generex Biotechnology Corporation
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1. Generex Announces Presentations of Antigen Express AE37 Breast Cancer Vaccine Data at ASCO 2012
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4. Generex Reports on Inaugural AE37 Breast Cancer Vaccine Scientific Advisory Board Meeting
5. Generex Announces OncUView.tv Interviews Featuring the Antigen Express AE37 Breast Cancer Vaccine at ASCO 2012
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9. Generex Provides an Overview of its Cancer Immunotherapy Product, AE37, and Potential in Early Breast Cancer Given Current and Potential Future Therapies
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