Generex' Oral-lyn packaged for trials

Generex Biotechnology, a US leader in drug delivery for metabolic diseases through the inner lining of the mouth, says that canisters of Generex Oral-lyn, its proprietary oral insulin spray product, have been labeled and packaged for Phase III clinical trial sites in the USA, Canada and the Ukraine. Both placebo and active canisters are ready to be shipped to the clinical sites which will permit the initiation of the pivotal study.

The Phase III protocol, identified as GEN084-OL, calls for a six-month evaluation which is expected to include 750 patients with type 1 diabetes mellitus. The company previously received a non-objection letter from Health Canada to conduct this pivotal study and the US Food and Drug Administration did not object to it. The primary objective of the trial is to compare the efficacy of Generex Oral-lyn and the RapidMist Diabetes Management System with that of standard regular injectable human insulin therapy as measured by Hba1c in patients with type 1 diabetes mellitus.