Generex Announces Updated Phase I Results From Novel Immunotherapeutic Vaccine Presented at the European Association of Urology Congress

Generex Biotechnology announced presentation of additional results from a recently completed Phase I clinical trial of its novel immunotherapeutic peptide AE37 in prostate cancer patients

WORCESTER, MA, USA | April 27, 2010 | Generex Biotechnology Corporation (Nasdaq:GNBT - News) ( today announced presentation of additional results from a recently completed Phase I clinical trial of its novel immunotherapeutic peptide AE37 in prostate cancer patients. AE37 is a synthetic cancer vaccine being developed by Antigen Express, Inc. (, a wholly owned subsidiary of Generex, for multiple cancer indications. The presentation was made at the 25th Anniversary Congress of the European Association of Urology (EAU) (, which was held in Barcelona, Spain from April 16 through April 20.

In addition to safety and the demonstration of a specific immunological response to AE37, it was shown that circulating levels of the extracellular domain of the HER2 protein were decreased in immunized patients compared to pre-vaccine levels. The AE37 vaccine was designed using a fragment of the HER2 protein and proprietary modifications developed at Antigen Express. The immunity generated by AE37 appeared to be long lasting, as significant vaccine-specific delayed type hypersensitivity (DTH) reactions were still apparent 6 months after the end of vaccinations. These results add to the body of data previously generated showing that AE37 is safe and immunologically active. Interim results from an ongoing Phase II trial of AE37 in breast cancer patients indicated that there were fewer recurrences in patients receiving AE37.

The EAU represents the leading authority within Europe on urological practice, research and education. Over 13,000 medical professionals have joined its ranks and help to create forward-looking solutions for continuous improvement, professional growth, and knowledge sharing.

The EAU delivers training, stimulates research, and broadcasts information. The EAU's scientific publications encourage discussion and its expert recommendations guide urologists in their every-day practice.

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 has been launched 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 or the Antigen Express website at

SOURCE: Generex Biotechnology Corp.

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