Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, said it has received an additional regulatory approval letter for the conduct of its phase III clinical trial protocol for Generex Oral-lyn 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 enrolment 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.
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 worldwide. The company has already received a non-objection letter from Health Canada for the conduct of this pivotal study and the FDA objection period has lapsed. 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 that additional phase III centres for our flagship product are being initiated," said Anna Gluskin, the president and chief executive officer. "Expected enrolment at these sites represents more than half of the 750 patients who will be participating in the pivotal study and we are confident that, with our systematic approach, approvals of the balance of the clinical sites will be forthcoming."
OSMOS Clinical Research, Inc. of San Francisco, California, which is assisting Generex with global project management, together with PSI-CRO AG, which is responsible for implementation of the trial activities in Eastern Europe, Canada and USA, are initiating the sites that have received regulatory approvals and patient enrolment will begin shortly, the company said.