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| Generex starts Oral-lyn phase III trial |
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| News - Nanomedicine and Drug Delivery News Archive | |
| Tuesday, 16 September 2008 | |
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Over 200 subjects are enrolled in Oral-lyn’s Phase III clinical trial of a prandial oral insulin spray produced by Generex Biotechnology Corporation. The Phase III clinical is to involve up to 750 subjects with type I Diabetes Mellitus (DM) in seventy-four different centers in the United States, Canada, Bulgaria, Poland, Romania Russia and Ukraine who will screen the company’s oral insulin spray product. The long-term study’s objective is to compare the efficacy of of Generex Oral-lyn(TM) and the company's RapidMist(TM) Diabetes Management System with prandial injections of regular human insulin as measured by HbA1c. The company’s goal is to offer a safe, simple, fast, effective, and pain-free alternative to prandial insulin injections, thereby improving subject compliance with therapeutic regimes, and delaying the progress of diabetes and the onset of its range of complications. Generex researches, develops, and commercializes drug delivery systems and technologies, and developed a proprietary platform technology for the administration of drugs through the oral cavity (with no deposit in the lungs). Drugs typically administered by injection can thus be absorbed into the body by the lining of the inner mouth using the RapidMist(TM) device. Generex Oral-lyn(TM) is already approved for commercial sale in Ecuador and India. Source: Generex Biotechnology Corporation
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