Generex to initiate Ph III trial of Oral-lyn

USA-based Generex Biotechnology is preparing to commence a Phase III clinical trial of Oral-lyn, its proprietary oral insulin spray product. The company has been establishing regulatory and clinical management teams to execute the trials in the USA and abroad.

The clinical trial will be undertaken pursuant to a Phase III protocol approved by Health Canada. The US Food and Drug Administration's review period for the protocol recently lapsed without objection, the firm noted, and it now expects to begin dosing patients before the end of the year in centers in the USA, Canada and Europe. The six-month trial is expected to include 750 patients with type 1 diabetes mellitus.

The primary objective of the study is to compare the efficacy of Generex' Oral-lyn and RapidMist Diabetes Management System with that of standard regular injectable human insulin therapy as measured by HbA1c.