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
Generex Biotechnology Corporation announced that on January 22, 2008 the Ministry of Health of the Ukraine issued an approval letter for the conduct of a Phase III clinical trial protocol for Generex Oral-lyn at eight clinical sites located in the Ukraine. The significance of this approval is that it represents initiation of the first clinical sites for the pivotal study and permits commencement of screening for suitable patients. This approval is the first of seven countries within which the Company will be conducting the Phase III trial of Generex Oral-lyn.
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.
Other news from the department research and development
