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Generex Announces Publication on Application of Antigen Express Technology for Early Detection of Type 1 Diabetes

WORCESTER, Mass. and TORONTO, May 3, 2011 /PRNewswire/ -- Generex Biotechnology Corporation ( (OTCBB: GNBT) today announced publication of results of studies applicable to the early diagnosis, and possibly treatment of, Type 1 diabetes.  The study, entitled: "Recognition of Ii-Key/MHC Class II Epitope Hybrids Derived from Proinsulin and GAD Peptides by T Cells in Type 1 Diabetes" appears in the April issue of the international peer-reviewed journal Hormone and Metabolism Research.  The article reports on the results of a collaborative study between scientists in the laboratory of Professor Paolo Pozzilli at the University Campus Bio-Medico in Rome, Italy and scientists at Generex's wholly-owned subsidiary, Antigen Express, Inc. (


The methodology reported in the publication for identification of autoimmune cells in diabetic patients relies upon the Ii-Key technology developed at Antigen Express.  Specifically, attaching the Ii-Key segment to an antigenic peptide designed to activate CD4+ T helper cells increases the potency of the peptide while not altering its specificity.  To date, this technology has been used successfully to increase the potency of a variety of antigenic peptides.  The most advanced Ii-Key modified peptide clinically is a HER2 peptide that is currently in a Phase II clinical trial as an immunotherapeutic vaccine for patients with breast cancer.

In the case of Type 1 diabetes, autoimmunity is directed at insulin producing cells in the pancreas; in particular, towards the proinsulin and glutamic acid decarboxylase (GAD65) proteins.  The study reports that Ii-Key modified peptides from each of these proteins were capable of detecting autoimmune T cells in the blood from patients with Type 1 diabetes but not in the blood from normal individuals.  Unmodified peptides showed lower sensitivity in detecting autoimmune T cells that the peptides bound to the Ii-Key.  "The ability to identify Type 1 diabetics early in the course of the disease using this method would greatly facilitate management of the disease," commented Professor Pozzilli.  "The current study shows that Ii-Key hybrid technique has clear potential in this regard and may be eventually useful to design a clinically strategic plan to suppress autoimmunity associated with Type 1 diabetes."

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 buccal insulin spray product, Generex Oral-lyn™ 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 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 immunotherapy.  One of its platform technologies relies on inhibition of expression of the Ii protein.  Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T helper cells and prevents the further growth of cancer cells.  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 or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

SOURCE Generex Biotechnology Corporation
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