Generex Announces Updated Phase I Results From Novel Immunotherapeutic Vaccine Presented

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

WORCESTER, Mass., Apr 27, 2010 (GlobeNewswire via COMTEX News Network) -- Generex Biotechnology Corporation (Nasdaq:GNBT) ( 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

Safe Harbor Statement

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," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," 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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

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SOURCE: Generex Biotechnology Corp.

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