WORCESTER, Mass. and TORONTO,May 3, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today announced publication of results of studies applicable to the early diagnosis, and possibly treatment of, Type 1 diabetes. The study, entitled: “Recognition of Ii-Key/MHC Class II Epitope Hybrids Derived from Proinsulin and GAD Peptides by T Cells in Type 1 Diabetes” appears in the April issue of the international peer-reviewed journal Hormone and Metabolism Research. The article reports on the results of a collaborative study between scientists in the laboratory of Professor Paolo Pozzilli at the University Campus Bio-Medico in Rome, Italy and scientists at Generex’s wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).
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The methodology reported in the publication for identification of autoimmune cells in diabetic patients relies upon the Ii-Key technology developed at Antigen Express. Specifically, attaching the Ii-Key segment to an antigenic peptide designed to activate CD4+ T helper cells increases the potency of the peptide while not altering its specificity. To date, this technology has been used successfully to increase the potency of a variety of antigenic peptides. The most advanced Ii-Key modified peptide clinically is a HER2 peptide that is currently in a Phase II clinical trial as an immunotherapeutic vaccine for patients with breast cancer.
In the case of Type 1 diabetes, autoimmunity is directed at insulin producing cells in the pancreas; in particular, towards the proinsulin and glutamic acid decarboxylase (GAD65) proteins. The study reports that Ii-Key modified peptides from each of these proteins were capable of detecting autoimmune T cells in the blood from patients with Type 1 diabetes but not in the blood from normal individuals. Unmodified peptides showed lower sensitivity in detecting autoimmune T cells that the peptides bound to the Ii-Key. “The ability to identify Type 1 diabetics early in the course of the disease using this method would greatly facilitate management of the disease,” commented Professor Pozzilli. “The current study shows that Ii-Key hybrid technique has clear potential in this regard and may be eventually useful to design a clinically strategic plan to suppress autoimmunity associated with Type 1 diabetes.”
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 device. The Company’s buccal insulin spray product, Generex Oral-lyn 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 immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T helper stimulation in immunotherapy. One of its platform technologies relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
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SOURCE Generex Biotechnology Corporation
