Generex Biotechnology to Initiate Phase III Clinical Trial of Generex Oral-lynT in 2007 Third Quarter
Company to Commence Patient Dosing by Year-end
The Company expects to begin dosing patients before the end of the year in centers in the United States, Canada, and Europe.
The six month trial is expected to include 750 patients with Type 1 diabetes mellitus. Patient enrollment is expected to begin during the third or fourth quarter of calendar year 2007 and expand to several global centers over the course of the study. The primary objective of the study is to compare the efficacy of Generex Oral-lynT and the RapidMistT Diabetes Management System with that of standard regular injectable human insulin therapy as measured by HbA1c, in patients with Type-1 diabetes mellitus.
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