Generex Biotechnology Corporation Receives Another Regulatory Approval to Conduct Phase III Clinical Trial for Generex Oral-lyn for One of the Largest Global Locations Selected by the Company

WORCESTER, Mass., Feb. 14, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that on January 10, 2008 the Company received an additional regulatory approval letter for the conduct of its Phase III clinical trial protocol for Generex Oral-lyn(tm) at an additional 28 clinical sites located in Europe. The significance of this approval is that it represents initiation of additional clinical sites for the pivotal study and permits commencement of screening for suitable patients. More importantly, these additional sites allow for an enrollment of up to 340 study subjects in addition to the sites which have already received regulatory approval to initiate the Phase III study. The Company will be conducting the Phase III trial of Generex Oral-lyn in a total of seven countries.

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