Diagnostic for Type 1 Diabetes in Children

A diagnostic kit for the early detection and screening of type 1 diabetes in children is being developed by two European diabetes centers and a U.S. company specializing in immunotherapeutics.

In vitro studies aimed at identifying the immune mechanisms leading to the destruction of the insulin-producing cells of the pancreas and the onset of type 1 diabetes will be the first step. The studies will focus on the role that lymphocytes (T-cells) play in a series of pancreatic antigens, the most common being GAD (glutamic acid decarboxylase), IAA (tyrosine phosphatase), and IA (insulin). Although these antigens have previously been measured by other investigators, the goal of the current studies is to identify and characterize the T-cells themselves in order to design strategies that can block their cytotoxic effects. Antigen Express (Worcester, MA, USA) will work with the University Campus Bio-Medico (Rome, Italy) and St. Bartholomew's Hospital in London (UK) to characterize these lymphocytes in order to establish a better screening parameter for people at risk for type 1 diabetes, earlier diagnosis, and possible intervention. Antigen Express is a subsidiary of Generex Biotechnology Corp. (Toronto, Canada; www.generex.com).

"The implications of this program are significant,” said Dr. Gerald Bernstein, director of medical affairs at Generex. "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.”

Although type 1 diabetes mellitus constitutes only 5-10% of all cases of diabetes, its impact can be devasting, especially for the parents of a young child affected by the disease. The best prevention has yet to be determined, but scientific experts agree that high-probability screening is important.

"We believe early detection plays a key role in treating type 1 diabetes,” said Anna E. Gluskin, president and CEO of Generex. "Generex is a company focused on developing novel mechanisms to treat diabetes in many ways.”

Generex Biotechnology Corp. acquired Antigen Express in 2003. The products of Antigen Express in development are based on two platform technologies: Ii-Key hybrid peptides and Ii-suppression. These were discovered by Dr. Robert E. Humphreys, M.D., Ph.D., the founder of Antigen Express.

The technology works by inducing specific potent immune responses to activate or deactivate the immune system. The Antigen Express technologies are designed to boost T-helper cell responses, which in turn elicit strong antibody and cytotoxic cellular responses. T-helper cells also mediate immunologic memory, crucial for long-term disease-free responses.





Related Links:
Generex
St. Bartholomew's Hospital
U. Campus Bio-Medico