The Ministry of Health of the Ukraine issued an approval letter to Generex Biotechnology Corporation to conduct a phase III clinical trial protocol for Generex Oral-lyn at eight clinical sites in the Ukraine.

The approval 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.

\"We are excited to initiate the first of our global phase III centres for our flagship product,\" said Anna Gluskin, the president and chief executive officer, Generex. \"After months of preparation and particular attention to detail and refining the protocol, the Company\'s plans for this pivotal study are starting to become a reality and we look forward to rolling out all the other clinical centres.\"

Generex is engaged in the research, development, and commercialisation of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity.