Generex Biotechnology initiates Phase III trial of oral insulin spray
Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, is to commence a Phase III clinical trial of Generex Oral-lyn, its proprietary oral insulin spray product.
Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, is to commence a Phase III clinical trial of Generex Oral-lyn, its proprietary oral insulin spray product.
The company expects to begin dosing patients before the end of the year in centres in the US, 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 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.
Generex has engaged OSMOS Clinical Research, of San Francisco, CA, to assist the with global project management of the Phase III clinical trial.
In addition, the company has engaged Beckloff Associates, a Cardinal Health company, to assist with the Generex Oral-lyn Phase III study through the design and implementation of efficient global scientific and regulatory strategies.