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Generex Subsidiary Antigen Express Provides Update on Phase 2 Breast Cancer Immunotherapy Program
Date:8/18/2011

ntermediate 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 immu
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