Study Finds Generex Oral-lyn(TM) is Safe, Effective, May Reduce Complications of Insulin-Dependent Diabetes

International Diabetes Federation guidelines identify glycemic control as a crucial factor in management of the disease, yet ensuring insulin therapy compliance can be problematic when up to one-quarter of people with diabetes have needle anxiety (Diabetes Res. Clin. Pract. 1999;46:239-46).

"Patients who are needle averse face a serious barrier to their recommended treatment," warns Generex President and CEO Anna E. Gluskin. "Generex Oral-lyn(TM) promises a pain-free alternative to injectable insulin, which is good news especially for older patients and children who find needles uncomfortable."

The clinical trials of Generex Oral-lyn(TM) include patients with Type 1 and Type 2 diabetes. Incidence of Type 1 diabetes is growing by 3 percent per year in children and adolescents, and at an alarming 5 percent per year among pre-school children. It is estimated that 70,000 children under the age of 15 develop Type 1 diabetes each year -- a rate of almost 200 children each day. Currently, an estimated 440,000 children globally live with Type 1 diabetes. Type 2 diabetes was once seen as a disease of adults, but is also growing at alarming rates in children and adolescents.

"Review of clinical trials: update on oral insulin spray formulation" was authored by Paolo Pozzilli, MD, Director of Endocrinology and Diabetes, University Campus Bio-Medico, Rome; Philip Raskin, MD, Department of Internal Medicine, Southwestern Medical Center, Dallas; and Christopher G. Parkin, MS, Carmel, Indiana. The article was published online this month in advance of print publication in Diabetes, Obesity and Metabolism. The article is available at http://tr.im/DOM09.

About Generex Biotechnology Corporation

Generex is engaged in the research, development and commercialization 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(TM) device. The Company's flagship product, oral insulin (Generex Oral-lyn(TM)), which is available for sale in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

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