Strong insulin control for Generex' Oral-lyn

Canada's Generex Biotechnology Corp reported strong new clinical data from a trial of Oral-lyn, its proprietary oral insulin spray. The study compared the effects of two forms of mealtime insulin in patients with type-1 diabetes maintained on basal isophane insulin (NPH): Generex' Oral-lyn versus pre-prandial subcutaneous injections of regular bolus insulin.

According to the firm, the study demonstrated that both treatments achieved near normalization of metabolic control parameters as reflected by continuous improvement in fructosamine and HbA1c concentrations. The findings will provide the format for a late-stage pivotal trial of the product, which will begin in early 2007, Generex noted.

NPH is an intermediate-acting insulin that peaks between six to eight hours and may last eight to 10 hours or more. It has, in recent years, been replaced in some parts of the world by glargine, a basal insulin analog. Regular insulin is a bolus or mealtime insulin taken a half hour before eating to combat post-meal blood glucose surges. Oral-lyn is regular bolus insulin delivered by spray into the mouth (using the company's proprietary RapidMist device) and is designed to replace mealtime insulin.