GNBT,
Generex Biotechnology Announces New Oral Insulin Clinical Data
Tuesday November 28, 9:45 am ET
Results Show Achievement of Improved Glucose Control in Patients With Type-1 Diabetes
TORONTO--(MARKET WIRE)--Nov 28, 2006 -- Generex Biotechnology Corporation (NASDAQ:GNBT - News), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced new clinical data from a trial of Generex Oral-lyn, the Company's proprietary oral insulin spray product.
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The study compared the effects of two forms of prandial (mealtime) insulin in patients with Type-1 diabetes mellitus maintained on basal isophane insulin (NPH): Generex Oral-lyn versus pre-prandial subcutaneous injections of regular bolus insulin.
NPH is an intermediate acting insulin that peaks between 6-8 hours and may last as long as 8-10 hours or more. It has in recent years been replaced in some parts of the world by glargine, a basal insulin analogue. Regular insulin is a bolus or mealtime insulin taken a half hour before eating to combat post-meal blood glucose surges. Generex Oral-lyn is regular bolus insulin delivered by spray into the mouth (using the Company's proprietary RapidMist(TM) device) and is designed to replace mealtime insulin injections. NPH is the only longer acting insulin used in many parts of the world. The pharmacokinetics of Generex Oral-lyn (duration 2 hours) make it complementary to NPH, both functionally and economically. Unlike "inhaled" insulin products, Generex Oral-lyn does not enter the lungs; rather, the insulin is absorbed by the inner lining of the mouth.
In this study, 11 subjects in the control group received twice daily injections of NPH and three pre-meal injections of regular insulin. 14 subjects in the treatment group received twice daily injections of NPH and three split-dose applications of Generex Oral-lyn (i.e. RapidMist puffs of Generex Oral-lyn before and after meals). The comparison phase, following a stabilization phase, lasted 99 days with fructosamine and glycated hemoglobin (HbA1c) determined, on average, every 14 days.
The study demonstrated that both Generex Oral-lyn and mealtime injections of regular insulin achieved near normalization of metabolic control parameters as reflected by continuous improvement in fructosamine and HbA1c concentrations. In fact, a straightforward comparison of HbA1c during the comparison phase showed a superior effect for Generex Oral-lyn. By providing a safe, simple, fast, flexible, familiar, and effective alternative to mealtime insulin injections, Generex Oral-lyn is designed to improve patient compliance which promotes metabolic stability which in turn delays the onset and reduces the severity of the complications associated with diabetes.
This study provides the format for the Company's pivotal late-stage, long-term trial of Generex Oral-lyn in 300 patients which will begin early in 2007. |
