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news.Generex Biotechnology has initiated dosing of over one hundred patients in the company's pivotal Phase III clinical trial of Generex Oral-lyn, its flagship proprietary oral insulin spray product.
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The Phase III study will involve up to 750 patients with Type-1 Diabetes Mellitus centers in the US, Canada, Russia, and Eastern Europe. Dosing of patients is now underway at 31 clinical trial sites in the US, Canada, Russia, and Ukraine.
The objective of the six-month study is to compare the efficacy of Generex Oral-lyn and the company’s RapidMist diabetes management system with prandial injections of regular human insulin as measured by HbA1c.
The company believes that Generex Oral-lyn will offer a safe, simple, fast, effective, and pain-free alternative to prandial insulin injections, which will improve patient compliance with therapeutic regimes, thereby delaying the progress of diabetes and the onset of its myriad complications.
Generex Oral-lyn is presently approved for commercial sale in India and Ecuador. The delivery of Generex Oral-lyn clinical supplies to global sites and centers, including Ukraine and Russia, is ongoing with other regional rollout to follow.