Review of Clinical Trials of Oral Insulin: Oral-lyn

WORCESTER, Mass., Dec 3, 2009 (GlobeNewswire via COMTEX News Network) — Published in the journal Diabetes, Obesity and Metabolism, an independent review of clinical trials of Generex Oral-lyn(TM) shows that the oral insulin spray has a faster onset of action and shorter duration of action than insulin delivered subcutaneously.

“The ease of use of the insulin spray formulation may increase patient acceptance and treatment compliance, thereby potentially reducing complications and improving quality of life for patients with insulin-dependent diabetes,” the review authors wrote.

Generex Oral-lyn(TM) is the flagship product of Generex Biotechnology Corporation (Nasdaq:GNBT) (, the leader in drug delivery for metabolic diseases through the inner lining of the mouth. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn(TM) does not have pulmonary side effects. It is safely and efficiently delivered in pain-free, standardized doses via the Company’s proprietary RapidMist(TM) device, which looks like a simple asthma inhaler, but provides complete absorption through the buccal mucosa (lining of the mouth) with no deposit in the lungs.

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

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