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Generex Biotechnology, and their wholly owned subsidiary Antigen Express, are developing promising new drugs to treat diabetes, as well as synthetic peptide vaccines targeting HER2/neu cancer and pandemic flu. The flagship product for Generex is Oral-lyn buccal insulin. Antigen Express' leading vaccine is the AE37 HER2/neu synthetic peptide vaccine to prevent breast cancer recurrence. I am not qualified to offer investment or medical advice, and make no claims that I am an expert in these areas. I am a layman and a shareholder in this company. The left side of Pipeline Review holds blogs regarding Generex and Antigen Express, while the right side offers items of due diligence mixed with my analysis which may be of interest to others seeking to learn about Generex's pipeline. If the left side only shows the latest blog, click on the word home to view them all.

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Sunday, March 13, 2011

A New Way to Treat Subjects with Impaired Glucose Tolerance: Buccal Spray Insulin

The 4th International Congress on Prediabetes and the Metabolic Syndrome will take place in Madrid, Spain, April 6-9, 2011. There is an abstract that will be presented on April 7th, titled "A New Way to Treat Subjects with Impaired Glucose Tolerance: Buccal Spray Insulin", which reports the Phase II study results for Oral-lyn with IGT patients.

In people with IGT, the levels of blood glucose are between 140 - 199 mg/dL after a two-hour oral glucose tolerance test. This level is higher than normal but not high enough to be classified as diabetes. Recent data suggests that higher glucose levels within the normal range increase risk for developing prediabetes. The prevalence of pre-diabetes is high. According to data from the 2011 National Diabetes Fact Sheet, 79 million people in the U.S. have prediabetes (IGT).

This is the accepted abstract (#1138):

A. Palermo1, N. Napoli1, E. Maddaloni1, A. Lauria Pantano1, S. Manfrini1, M. Altomare2, S. Leotta2, P. Pozzilli1
1Endocrinology and Diabetes, University Campus Bio-Medico, 2Diabetes, Hospital Sandro Pertini, Rome, Italy

In patients with impaired glucose tolerance (IGT), upon implementation of life style changes and metformin, a third returns to normal glucose tolerance, a third continues with IGT and the rest develops type 2 diabetes. An increased risk for cardiovascular disease occurs in the latter two groups. A previous study demonstrated that treatment with 12 puffs of buccal spray insulin (BSI) was followed by a significant 29.6% decrease in mean plasma glucose at 2h and by a 26.8% decrease at 3h.

This is a randomized controlled trial in patients with IGT comparing BSI (12 puffs per meal) plus physical exercise and diet (n=16, entry HbA1c 6.06%+0.5 ) vs. physical exercise and diet only (n=16, entry HbA1c 5.9%+0.3). HbA1c, metabolic parameters and insulin antibodies (IA) were measured at baseline, at 3 and at 6 months. Primary endpoint is the reduction of HbA1c of 0.3% at 6 month treatment between the experimental and the control group. Secondary endpoints include evaluation of IA, changes in body weight and number of hypoglycaemic events.

Subjects treated with BSI achieved a significant reduction of HbA1c compared to the control group (ΔHbA1c 0'-3' month -0.3% vs+0.09% p= 0.002). No difference in body weight and no hypoglycaemic or other adverse events were observed in both groups. No generation of IA was observed in subjects treated with BSI.

These results indicate that BSI is an effective treatment in patients with IGT in reducing HbA1c without adverse effects. A larger trial is required to demonstrate the long term effects of this therapy.

To view the abstract, click here.