Generex Presents Encouraging Interim Results of Phase II Breast Cancer Study

Novel Immunotherapeutic Breast Cancer Vaccine on Track for Demonstration of Efficacy

WORCESTER, MA, USA | December 14, 2009 | Generex Biotechnology Corporation (Nasdaq:GNBT - News) (www.generex.com) today announced presentation of interim results from a Phase II efficacy study of a novel immunotherapeutic vaccine being developed by its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The results were presented at the 32nd Annual San Antonio Breast Cancer Symposium (www.sabcs.org). The trial is being conducted by COL George Peoples, MD, a collaborator of Antigen Express working at the Brooke Army Medical Center.

The presentation, entitled Interim analysis of a randomized phase II study of the novel Ii-Key hybrid HER2/neu peptide (AE37) vaccine to prevent breast cancer recurrence: United States Military Cancer Institute Clinical Trials Group Study I-05, showed that only half the number of patients in the treatment arm of the study relapsed compared to those not receiving the vaccine. The trial is a fully randomized and controlled study examining the rate of relapse in patients diagnosed with node-positive or high risk node negative breast cancer. The final endpoint will examine the relapse rate after two years; the results presented at the conference were those observed in patients 13.5 months after treatment.

Antigen Express, Generex's immunotherapy division, is developing novel synthetic peptide vaccines for potent and specific stimulation of CD4+ T helper cells. The vaccine being studied in this trial, AE37, was shown to be safe, well-tolerated and produced the desired immunological activity in both a Phase I trial in breast cancer patients and a Phase I trial in patients with prostate cancer. AE37 is also the subject of an additional Phase I clinical trial in patients with breast or ovarian cancer in which it is being combined with another immunotherapeutic peptide.

In addition to cancer, the proprietary Antigen Express technology is being applied to vaccine development for infectious diseases. In particular, a synthetic peptide vaccine is currently being developed for the H1N1 swine flu virus.

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(TM) device. The Company's flagship product, oral insulin (Generex Oral-lyn(TM)), which is available for sale in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

SOURCE: Generex Biotechnology Corp.

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