Generex Biotechnology to Initiate Phase III Clinical Trial of Generex Oral-lynT in 2007 Third Quarter
Company to Commence Patient Dosing by Year-end
Generex Biotechnology Corporation announced that the Company is preparing to commence a Phase III clinical trial of Generex Oral-lyn, the Company's proprietary oral insulin spray product. The Company has been establishing regulatory and clinical management teams to execute the trials in the United States and abroad. The clinical trial will be undertaken pursuant to a Phase III protocol approved by Health Canada. The United States food and Drug Administration's review period for the protocol recently lapsed without objection.
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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