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
Generex Biotechnology Corporation announced that it has initiated enrolled over 150 patients in the Company's pivotal Phase III clinical trial of Generex Oral-lyn(TM), its flagship proprietary oral insulin spray product. Of those patients, over 100 have been dosed. There are 55 sites in the United States, Canada, Bulgaria, Russia, Poland and Ukraine actively screening and enrolling patients, including 39 clinical trial sites in where patients are being dosed. Generex Oral-lyn(TM) has been shipped to all of the sites.
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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