News Next Week for Generex May Reduce Need for Reverse Split

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News next week at the meeting for the European Association for the Study of Diabetes in Stockholm from September 20-24, 2010, will come in the form of a paper which will show that Generex's (GNBR) buccal spray does not develop autoimmunity versus other methods of intake including needle injection. The paper's title is, " No Generation of Insulin Antibodies in Subjects with Impaired Glucose Tolerance Treated with Buccal Spray Insulin."

This research suggests yet another reason for the FDA to approve a new technique for delivery of insulin through the mouth (but not the lungs) that will dramatically improve the life of diabetics in that 1) it is an easy delivery method (no painful needle pricks), and 2) that it will improve compliance.

Approval would make this company a target for many of the large pharmaceutical companies: Pfizer (PFE), which shelved its lung absorption product Exubera; Novo-Nordisk (NVO), the largest maker of insulin, which also spent money on lung absorption, Lilly (LLY), which showed any early interest in the buccal absorption technique; and Merck KGaA, the German Merck, which just signed a deal to distribute Generex's Ora-lyn in Mexico. Investors are not likely to ignore the importance of this news development.

Background and aims: 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 goes on to develop clinical type 2 diabetes. An increased risk for cardiovascular disease occurs in the latter two groups even though there is no progression to diabetes. The implementation of treatment strategies to lower postprandial hyperglycaemia has been recommended by the IDF guidelines.

A previous proof of concept study demonstrated that treatment with buccal spray insulin (Oral-lyn™) can be a valuable tool for managing subjects with IGT. Thus, treatment with 12 puffs was followed by a significant 29.6% decrease in mean plasma glucose at two-hours and a 26.8% decrease at three-hours Considering all time points OGTT, there was a mean reduction of 15.8% in mean plasma glucose following buccal spray insulin. No hypoglycaemia episodes were recorded. The aim of this study was to evaluate the effect of Oral-lyn™ on metabolic and immunological parameters in subjects affected by IGT who were exposed to long term treatment with this insulin formulation.

Material and Methods: We have designed a randomized controlled trial in 36 subjects with IGT comparing buccal spray insulin (12 puffs per meal) plus physical exercise and diet vs. physical exercise and diet only (control group). Primary endpoint is the reduction of HbA1c of 0.3 % at 6 month treatment between the experimental vs control group. Secondary endpoints include the evaluation of production of antibodies against insulin (IA), glucose variability (measured with continuous glucose monitoring), changes in body weight, number of hypoglycemic events after buccal spray insulin treatment. Insuiln antibodies were measured using a DASP recognized assay.

Results: Subjects enrolled in the treatment group did not suffer of hypoglycaemia episodes. IA were negative at entry into the study in IGT subjects and treatment with buccal spray insulin did not induce generation of IA.