WORCESTER, Mass., Aug. 5, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), 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(tm) 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.
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(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at www.generex.com.
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Safe Harbor Statement
This release and oral statements made from time to time by Generex representatives concerning 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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.