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Generex Biotechnology Corporation (GNBT) Receives Regulatory Approval

Generex Biotechnology Corporation (GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced that the Ukraine Ministry of Health has issued an approval letter regarding the company’s pertinent Phase III clinical trial of Oral-ly. The Ministry specified that the company will be able to conduct their trials at eight clinical sites located in Ukraine.

This letter represents the initiation of the first clinical sites for the pivotal study of Oral-ly. Additionally, this particular approval is the first approval from seven countries which Generex seeks to conduct their Phase III trial. The Company has already received non-objection letters from both Health Canada and the FDA to conduct this pivotal study.

This clinical trial will call for a six month active treatment period and a six month follow up period.

Anna Gluskin, Generex’s CEO, stated, “We are excited to initiate the first of our global Phase III centers for our flagship product. 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 centers.”

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