Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, has received approval from the ethics committee at University Campus Bio-Medico of Rome to conduct a Generex Oral-lyn trial with subjects diagnosed with or susceptible to developing Impaired Glucose Tolerance (IGT). The endpoint of the study is to determine if glucose levels will drop when subjects use Generex Oral-lyn, the company's proprietary oral insulin spray product, with the company's proprietary RapidMist drug delivery device.

IGT is a pre-diabetic condition. 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 pre-diabetes. The prevalence of pre-diabetes is high. According to the National Diabetes Information Clearinghouse (NDIC), about fifty-seven million American adults had pre-diabetes in 2007.

Future studies in this therapeutic area will not only continue to evaluate product safety and efficacy, but will also determine the subjects' satisfaction to treat pre-diabetes with a non-invasive insulin product that compliments the regularly prescribed regimen of exercise and weight loss.

"We are looking forward to conducting this trial and await the results with great interest," said Prof. Paolo Pozzilli of University Campus Bio-Medico. "While it is not yet known whether the treatment of IGT can delay or prevent diabetes or associated diseases such as cardiovascular disease, the delay of onset for high risk people will itself provide benefit in terms of morbidity and complications associated with the disease. We look forward to determining if the introduction of Generex Oral-lyn, as a non-injectable alternative, in the pre-diabetes state can play a role in empowering people to control daily glucose levels."

Generex Oral-lyn is presently approved for commercial sale in India and Ecuador as an oral insulin spray product. In addition, Generex Oral-lyn is in phase III trials at thirty-one clinical trial sites in the United States, Canada, Russia, and Ukraine. The trial involving IGT subjects is for a separate indication than these phase III trials and commercialization of the product.