New positive data on Generex Oral-lyn published in Diabetes, Obesity and Metabolism

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.