Generex's Oral-lyn Matches Fast-Acting Insulin in Phase IIb Study

Generex Biotechnology, a leader in the area of buccal drug delivery, has reported results of a recently completed Phase IIb clinical study of Oral-lyn in which Oral-lyn successfully replaced rapid-acting insulin in patients with Type 1 diabetes mellitus.

This is the first report in which patients with Type 1 diabetes, using glargine insulin (Lantus) as their baseline therapy, have been maintained with optimal control using a schedule of meal oral insulin -- Generex's Oral-lyn -- during a period of nine days.

Unlike injection or various pulmonary delivery methods (in which a powdered or liquid insulin formulation is inhaled into and absorbed by the lungs), Oral-lyn is delivered as a fine spray to the buccal (oral) cavity via the company's proprietary Rapidmist delivery system. The result is rapid insulin absorption through the buccal mucosal lining of the mouth without pulmonary exposure or the pain and inconvenience of needles.