Generex Announces Enrollment of Over 150 Patients In Phase III Trial of Generex Oral-lyn
More than 100 patients currently receiving Generex Oral-lyn; Some Patients for more than Three Months
The Phase III study will involve up to 750 patients with Type-1 Diabetes Mellitus within centers in the United States, Canada, EU, Russia, Poland, Bulgaria, Rumania and Ukraine . The objective of the six-month study is to compare the efficacy of Generex Oral-lyn and the Company's RapidMist(TM) Diabetes Management System with prandial injections of regular human insulin as measured by HbA1c.
Generex Oral-lyn is presently approved for commercial sale in India and Ecuador. The delivery of Generex Oral-lyn clinical supplies to global sites and centers, including Ukraine and Russia, is ongoing with other regional rollout to follow.
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