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Generex Announces Publication of Paper on Buccal Spray Insulin

WORCESTER, Mass. and TORONTO, April 26, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT.OB) announced today that a paper in respect of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product, has been published in the peer-reviewed journal Expert Opinion on Biological Therapy.  The paper, entitled "Buccal spray insulin (Oralgen) for type 2 diabetes: what evidence?," is authored by Professor Paolo Pozzilli and Drs. Andrea Palermo and Ernesto Maddaloni of the Department of Endocrinology and Diabetes, University Campus Bio-Medico, Rome, Italy.  The abstract of the paper can be viewed online at the US National Library of Medicine, National Institutes of Health at

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The paper notes that, while the achievement of glycemic control, particularly the management of postprandial hyperglycemia, is the most significant treatment target for the management of diabetes, and that multiple daily insulin injections are required to achieve treatment goals, both patients and healthcare professionals are reluctant to initiate insulin therapy (which the authors term "psychological insulin resistance").  The paper suggests that non-compliance with injected insulin therapy, which compromises glycemic compensation processes, may be remedied by novel non-injectable insulin formulations and that Generex Oral-lyn™ (referred to as "Oralgen" in the paper), which provides insulin absorption via the buccal mucosa, appears "suitable to manage the postprandial hyperglycemia without hypoglycemic risk."

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. 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.

Cautionary Note Regarding Forward-Looking Statements

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," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" 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

Posted: April 2012