Generex Biotechnology Working to Develop Diagnostic Kit for Early Detection Of Type 1 Diabetes
Company to Collaborate with Leading European Diabetes Centers for Clinical Studies
Toronto. Generex Biotechnology Corporation announced that its wholly-owned subsidiary, Antigen Express, is working to develop a diagnostic kit for the early detection and screening of Type 1 diabetes in young children. The Company will shortly begin in vitro studies aimed at identifying the immune mechanisms leading to the destruction of the insulin producing cells of the pancreas and onset of Type 1 diabetes. Antigen Express will partner for these studies with two leading European diabetes centers, the University Campus Medico in Rome and St. Bartholomew's Hospital in London.
The studies will focus on the role that Lymphocytes (T-cells) play in a series of pancreatic antigens, the most common of which are GAD (glutamic acid decarboxylase), IAA (tyrosine phosphatase) and IA (insulin). These antigens have previously been measured by a number of investigators, but the goal of Antigen Express is to identify and characterize the T-cells themselves in order to design strategies to block their cytotoxic effects. Antigen Express will work with the European partners to characterize these lymphocytes in order to establish a better screening parameter for those at risk, earlier diagnosis and possible intervention.
Although Type 1 Diabetes Mellitus only constitutes 5 to 10% of all cases of diabetes, it's impact can be acutely devastating, especially for the parent of a young child affected by this disease. The best prevention has yet to be determined, but scientific experts agree that high probability screening plays an important role. This was highlighted by a front-page article by Michael Waldholz in the Wall Street Journal on March 1, 2004 where he addressed the issue and the efforts by a few investigators.
"We believe early detection plays a key role in treating Type 1 diabetes," said Anna E. Gluskin, President and Chief Executive Officer of Generex. "Generex is a company focused on developing novel mechanisms to treat diabetes in many ways. Our immunology program is the ideal compliment to our flagship product Oralin(TM), our novel buccal delivery insulin spray formulation. This latest development will expand our diabetes franchise."
"The implications of this program are significant," said Dr. Gerald Bernstein, Generex's Director of Medical Affairs. "While many are focused on a cure for diabetes and new glucose measuring devices, the solutions ultimately become more effective through early detection. This program is designed to test children at early ages, so that the disease management process can begin as soon as possible."
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