Generex Biotechnology Announces Additional Preliminary Results in a Trial of Generex Oral-lyn(TM) in Adolescent / Young Adult Patients With Type-1 Diabetes
TORONTO -- (MARKET WIRE) -- 03/15/06 -- Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today additional preliminary results (10 weeks) of a long-term (six month) clinical trial of Generex Oral-lyn, the Company's proprietary oral insulin spray product, in adolescent and young adult patients with Type-1 diabetes mellitus. This data, which complements the positive data announced by the Company on March 8, 2006, shows the variations of glycosylated hemoglobin (HbA1c), a very well-known marker for monitoring diabetes, during the first 10 weeks of the study.
Glycosylated hemoglobin (HbA1c) is considered by regulatory agencies and endocrinologists as the best long-term measure of metabolic control of diabetes. "HbA1c correlates with the level of risk for diabetes complications," said Dr. Gerald Bernstein, the Company's Vice-President for Medical Affairs. "The continuous and dramatic reduction seen in these preliminary results bode well for patients with diabetes, and society generally, in reducing the burdens of diabetes and its complications."
The investigators concluded that, during the first 10 weeks of this ongoing six-month trial, replacement of subcutaneous injections of regular insulin by Generex Oral-lyn at lunchtime in adolescent and young adult patients with Type-1 diabetes was associated with overall adequate glycemic control and similar glycosylated hemoglobin (HbA1c) concentrations.
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