WORCESTER, Mass., June 9, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, made two podium presentations of data from Company-sponsored studies at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA, www.diabetes.org) in San Francisco on June 7, 2008.
Internationally renowned diabetes investigator Professor Paolo Pozzilli of the Department of Endocrinology and Diabetes at University Campus Bio-Medico, Rome, Italy made a podium presentation of an abstract entitled "Detection of T Cell Response to Insulin and GAD in Type 1 Diabetes Using the Ii-Key Hybrid Technique." The abstract was co-authored by Marta Vadacca, Maria Giuditta Valorani, Robert Humphreys, Nikoletta Kallinteris, Luciana Valente and Paolo Pozzilli.
The study demonstrated that T cells from patients recently diagnosed with Type-1 diabetes responded differently to Ii-Key hybrid peptides derived from either the insulin or GAD protein compared to healthy volunteers. Specifically, 20% of peripheral blood cell samples from Type-1 diabetics responded to Ii-Key/insulin and 25% to Ii-Key/GAD hybrids by secreting cytokines while none of the blood samples from healthy volunteers responded to the same peptides. These findings suggest that the use of Ii-Key hybrids to characterize peripheral blood cells may be an efficient way of monitoring patients with Type-1 diabetes.
Dr. Huriya Beyan of the Centre for Diabetes and Metabolic Medicine, Institute of Cell and Molecular Science, St. Bartholomews Hospital, London, U.K., made a podium presentation of an abstract entitled "Study of T Cell Response to Ii-KEY/MHC Class II Epitope Hybrides in Human Type 1 Diabetes." The abstract was co-authored by Dr. Huriya Beyan and Professor David Leslie, both of the Institute of Cell and Molecular Science, as well as Dr. Eric von Hofe of Antigen Express, Inc., a wholly owned subsidiary of Generex.
For these studies, T cells from patients with well-established Type-1 diabetes were compared to cells from healthy volunteers for responsiveness to either the GAD protein or Ii-Key/GAD hybrids. A significantly increased frequency of specific T cell responsiveness, as demonstrated by interferon gamma release, was observed using T cells from diabetics as compared to T cells from healthy volunteers using either the peptides or GAD protein. Release of another cytokine (IL10) was not significantly different between diabetics and healthy volunteers. The similarities in cytokine profiles between the GAD protein and Ii-Key/GAD65 hybrids give hope for the use of Ii-Key hybrids both as a diagnostic for early detection of Type-1 diabetics and as a therapeutic to reduce the autoimmune component of this disease.
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 Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in Phase 3 clinical trials at several sites around the world. For more information, visit the Generex website at www.generex.com.
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