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Generex Makes Podium Presentation of Clinical Data on Generex Oral-lyn™ at European Association for the Study of Diabetes Annual Meeting

WORCESTER, Mass. and TORONTO, Sept. 16, 2011 /PRNewswire/ -- Generex Biotechnology Corporation ( (OTCBB: GNBT) announced today that Dr. Nicola Napolii, from University Campus Bio-Medico in Rome, Italy, made a podium presentation of the clinical data on Generex Oral-lyn™ buccal insulin spray on September 14, 2011 at the European Association for the Study of Diabetes (EASD) annual meeting in Lisbon, Portugal.


Dr. Napoli presented a paper entitled "Buccal spray insulin: a new tool to treat subjects with impaired glucose tolerance."  The paper was authored by a team of investigators led by Professor Paolo Pozzilli of the Endocrinology & Diabetes Department of University Campus Bio-Medico and the Diabetes Department of Hospital "S. Pertini", both in Rome, Italy.  The results reported in the scientific paper demonstrated that patients treated with Generex Oral-lyn™ achieved a significant reduction of HbA1c compared to the control group, with no adverse events.  Also, there was no significant difference in body weight and no hypoglycaemic or other adverse events were observed during the study period in both groups.  These preliminary results suggest that the addition of Generex Oral-lyn™ can be an effective treatment compared to diet and physical exercise alone in patients with impaired glucose tolerance (IGT) in reducing HbA1c without adverse effects.

"The results suggest Generex Oral-lyn™ will be an important therapy tool for adults with pre-diabetes conditions of IGT and elevated blood-sugar levels," said Mark Fletcher, the Company's President and Chief Executive Officer.  "The opportunity to successfully expand Generex Oral-lyn™'s use beyond Type 1 diabetes and Type 2 diabetes offers a validated therapy to not only treat and improve the quality of life of those who will eventually be diagnosed with diabetes, but also provides a solution for the diabetes medical community to potentially reduce or be able to prevent the progression of the complications that may arise from having diabetes."

Pre-diabetes is a condition in which individuals have blood glucose or A1c levels higher than normal but not high enough to be classified as diabetes. People with pre-diabetes have an increased risk of developing type 2 diabetes, heart disease, and stroke. According to the Centers for Disease Control and Prevention, in 2010 it is estimated that 79 million Americans aged 20 years or older have pre-diabetes while approximately 50% of Americans aged 65 and older have pre-diabetes.

About Generex Biotechnology Corporation

Generex is engaged in the research and development, 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.  For more information, visit the Generex website at or the Antigen Express website at

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
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