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Leading Investigator to Present Clinical Data on Generex Oral-lyn™ at International Diabetes Federation Meetings in Dubai

WORCESTER, Mass. and TORONTO, Dec. 7, 2011 /PRNewswire/ -- Generex Biotechnology Corporation ( (OTCBB: GNBT) announced today that a group of physicians led by Professor Paolo Pozzilli at the University Campus Bio-Medico in Rome, Italy, will provide an update on results of using Generex Oral-lyn™  as it pertains to prediabetes at  the forthcoming International Diabetes Federation (IDF) Congress, to be held in Dubai, December 3rd-8th, 2011.


The paper is entitled "Buccal Spray Insulin for The Treatment of Impaired Glucose Tolerance" and is presented by Dr. Y.M. Khazrai of Dr. Pozzilli's research team.

The study results confirm and significantly extend previous beneficial results showing that subjects with impaired glucose tolerance (IGT) treated with the Generex Oral-lyn™ buccal insulin spray achieved a significant reduction of 0.3% in HbA1c compared to the control group (∆ HbA1c 0'- 6 month  -0.3% vs +0.09%, p= 0.002).   Although the decrease in body weight in Generex Oral-lyn™ treated subjects did not reach significance in this short term study, there were no reports of hypoglycemia or other adverse events observed during the study period compared to control subjects.   These preliminary results suggest that the addition of Generex Oral-lyn™ can be an effective treatment compared to diet and physical exercise alone in subjects with IGT in reducing HbA1c and doing so without adverse effects.

"These results suggest Generex Oral-lyn™ will be an important therapy tool for adults with prediabetes conditions of IGT and elevated blood-sugar levels," said Dr. James H. Anderson, Jr., MD, FFPM, FACE, Generex's Senior Scientific Advisor.  "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 prevent the progression of the complications that may arise from having diabetes."

Prediabetes 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 prediabetes have an increased risk of developing type 2 diabetes, heart disease, and stroke.  According to the Center for Disease Control and Prevention, it is estimated that in 2010, 79 million people 20 years of age or older have pre-diabetes, and approximately 50% of Americans aged 65 and older have pre-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.  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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