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Preliminary Results in Trial of Generex Oral-lyn™ in Type 1 Diabetes

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 A1c concentrations.

Generex Biotechnology Corporation, 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.

Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company’s proprietary RapidMist™ device. The Company’s flagship product, oral insulin (Oral-lyn™), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
www.generex.com.

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FACT:
Low-Carb Diets Work for People With Diabetes: Yes, many already now that by their own experience, but researchers at Temple University School of Medicine have shown why low-carb diets work for weight loss, and it’s not related to water, metabolism or boredom, which are common misconceptions of the effects of this kind of diet. They studied a group of 10 obese patients with type 2 diabetes who were on the usual diet for 7 days (high carbs), followed by a low-carbohydrate diet (with carbohydrates limited to 20 grams per day and unlimited protein and fat) for 14 days. Although the study was short, had few participants and did not have a strict control group, scientists concluded that a low-carb diet followed for 2 weeks caused lower caloric intake; participants did not eat more protein or fat and lost weight. They also reported better blood glucose profiles, hemoglobin A1c and lowered levels of triglycerides and cholesterol.
Ann Intern Med. 2005 Mar 15;142(6):403-11.