Generex Biotechnology Announces Publication of Novel Immunotherapeutic Cancer Vaccine Studies

Review Highlights the Increased Immunological Potential of the Vaccine


WORCESTER, Mass., Jan. 12, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) announced today the publication of a report reviewing the studies performed to date with the immunotherapeutic agent AE37, which is being developed by the Company's wholly-owned immunotherapeutics subsidiary Antigen Express, Inc. (www.antigenexpress.com). The compound is currently the subject of a Phase II clinical trial in patients with breast cancer, a Phase I clinical trial in prostate cancer patients, and another Phase I clinical trial wherein the compound will be combined with another vaccine peptide in patients with either ovarian or breast cancer.

The report, entitled "CD4+ T cells in antitumor immunity: utility of an Ii-Key HER2/neu hybrid peptide vaccine (AE37)", appeared in the January 2009 issue of Expert Opinion on Biological Therapy (Vol. 9, No. 1, Pages 71-78) and is co-authored by Dr. Eric von Hofe, President of Antigen Express. The study reviews the clinical as well as the pre-clinical data on AE37, comparing it with other vaccines that have been investigated in the clinic. In addition to being shown to be safe and well tolerated in clinical studies, the report concludes that AE37 has superior immunogenicity to other peptide vaccines investigated to date. In addition, the value of specific CD4+ T cell stimulation is also underscored.

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. The Company's flagship product, oral insulin (Generex Oral-lyn), which is available for sale in India 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.

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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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