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Generex Announces Publication of New Positive Generex Oral-lyn™ Data in Peer-Reviewed Journal
Date:12/13/2010

WORCESTER, Mass., Dec. 13, 2010 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTC Bulletin Board: GNBT) announced today that the peer-reviewed scientific journal Diabetes, Obesity and Metabolism has published new positive data in respect of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product.

The paper, entitled Buccal spray insulin in subjects with impaired glucose tolerance: the prevoral study, appears in Volume 13, Issue 1 (January 2011) of the journal and is co-authored by a team from the Department of Endocrinology and Diabetes, University Campus Bio-Medico, Rome, Italy led by Professor Paolo Pozzilli and including: A. Palermo, N. Napoli, S. Manfrini, A. Lauria, and R. Strollo.

People affected by impaired glucose tolerance (IGT) represent more than 20% of the world's population and the prevalence of the condition is growing.  Approximately one-third of people with IGT develop clinical type 2 diabetes mellitus within three to five years of an IGT diagnosis.  More significantly, an increased risk for cardiovascular disease has been observed in IGT patients, even where type 2 diabetes does not develop.  Although diet and exercise (the treatment for IGT suggested by current American Diabetes Association guidelines) delay the onset of type 2 diabetes, long-term prospects are poor.

Because a reduced first phase insulin response is a key factor in diagnosing IGT, the use of insulin therapy to reduce post-prandial glucose levels could be a targeted treatment for IGT.  However, insulin therapy via subcutaneous injection is often rejected by patients and its use is generally limited to patients with type 2 diabetes where oral hypoglycaemic options have failed.

In Professor Pozzilli's proof-of-concept study, 31 subjects diagnosed with IGT, with a mean age of 52 years, and a body mass index of 33 (i.e. obese) received Generex Oral-lyn™ in equal doses before and 30 minutes after drinking 75 grams of glucose in a standard oral glucose tolerance test.  Glucose and insulin levels were measured at baseline and 30, 60, 90, 120, and 180 minutes after consuming the glucose.  Treatment with an aggregate of 12 Generex Oral-lyn™ sprays resulted in a 29.6% decrease in plasma glucose at two hours and a 26.8% decrease at three hours.  Overall, the study found a mean reduction in glucose levels of 15.8%.  Plasma insulin was also significantly increased at 30 minutes but not at 2 hours or 3 hours, demonstrating the important increase in first phase insulin availability.

The study demonstrates that treatment with Generex Oral-lyn™ is a simple and valuable therapy for reducing post-prandial hyperglycaemia in obese subjects with IGT.  Importantly, the treatment is safe and no subject experienced hypoglycaemia.  Professor Pozzilli commented that:  "The results of this study are of particular interest because they demonstrate that Generex Oral-lyn™ could be successfully employed to normalize post-prandial glucose levels in subjects with IGT.  The convenience of buccal absorption of insulin in subjects with IGT may represent a significant advantage in terms of therapeutic compliance."

Dr. James Anderson, a member of the Generex Scientific Advisory Board, noted that "This study is the first demonstration of directly increasing first phase insulin levels and reducing post prandial glucose using a non-invasive therapy.  The potential to use Generex Oral-lyn™ as a frontline treatment for patients with IGT could have far reaching implications.  If such a non-invasive therapy delayed the onset of diabetes along with all of its complications, it could eventually become a cost effective alternative to allowing the condition to progress with just diet and exercise."

As a result of these important findings, a second trial (Prevoral 2) is underway where subjects with IGT are being treated for six months with either (a) Generex Oral-lyn™ + diet and exercise, or (b) the standard IGT treatment of only diet and exercise.  The end-point of the Prevoral 2 study is represented by glycated haemoglobin values.  Initial promising data were presented in September at the 46th Congress of the European Association of the Study of Diabetes in Stockholm, Sweden.  Final results of the Prevoral 2 study will be available in mid-2011.

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™, which has been approved in India, Lebanon, Algeria, 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 immunotherapeutic vaccines 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.

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.


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