Generex Biotechnology has said that the Ministry of Health of Ukraine has approved the company to conduct a Phase III clinical trial protocol for Generex Oral-lyn at eight clinical sites located in the Ukraine.
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This approval represents initiation of the first clinical sites for the pivotal study and permits commencement of screening for suitable patients. This approval is claimed to be the first in 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 six month follow up which is expected to include up to 750 patients with type-1 diabetes mellitus.
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