Hi, I'm Dr. Mark Pescovitz, Professor of Surgery and Microbiology, Immunology, at Indiana University School of Medicine Indiana University School of Medicine located in Indianapolis, Indiana. As the only medical school in the state of Indiana, we're the primary referral site for patients with complex medical diseases, including type 1 diabetes.
We have developed and conducted a trial using a drug called rituximab. Rituximab is a drug that was originally developed to eliminate B cell cancers in patients. The B cell is a type of white blood cell that circulates through the body. Another type of white blood cell is called the T cell. Historically, it has been thought that the T cell is the cell that causes diabetes by attacking the pancreas, by attacking the islets of the pancreas, which actually make insulin. We have, however, proposed an alternative hypothesis, in that the B cells are what are called antigen-presenting cells. One way of thinking of this is that the B cells present food or give food to the T cell, to present antigen or food to these T cells. If you eliminate the B cells, the T cells no longer have the food that they need in order to continue to grow. If the T cells don't have the food, they will die, and therefore the attack on the pancreas will be stopped.
The study that we have conducted has just completed enrollment; it is a worldwide study conducted in the United States, Australia, Canada, and Europe. The 88 subjects were randomized, some receiving the drug retuximab, and some receiving a placebo or a fake drug.
We hope to have the first analysis of the data some time at the end of next year, after one year of study. The study however, will continue for another additional year to see whether the effect may be long-lasting.