Generex Biotechnology receives regulatory approval to initiate Phase III clinical trial for Generex Oral-lyn
Ministry of Health of the Ukraine approves Phase III protocol GEN084-OL for a number of clinical sites in the Ukraine
The protocol calls for a trial with a six month active treatment period and a 6 month follow up which is expected to include up to 750 patients with Type-1 diabetes mellitus worldwide. The Company has already received non-objection letters from both Health Canada and the FDA to conduct this pivotal study. The primary objective of the study is to compare the efficacy of Generex Oral-lyn and the Company's RapidMist 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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