Seattle, WA—Researchers at the Pacific Northwest Research Institute (PNRI, now PNDRI) in Seattle have launched a five-year study to test whether type 1 diabetes can be delayed or reversed. With a drug designed to prolong remaining insulin function in newly diagnosed patients, study scientists hope to be able to prolong the mild initial period of the disease, perhaps permanently.

Dr. William Hagopian, the Principal Investigator in Seattle at PNRI, is working in collaboration with researchers at five other sites throughout the country, to test the drug's effects. Hagopian and his colleagues here in Seattle have begun recruiting patients to enroll in the research.

"This is a pivotal study," Hagopian says. "Immediately after diagnosis, type 1 patients typically experience what's called a 'honeymoon period,' a short interval where they are still able to produce much of the insulin which their body needs on their own. We are hoping to be able to prolong that honeymoon for at least several years by giving the medicine repeatedly."

Type 1 diabetes is an autoimmune disease. The immune system eventually damages the cells in the pancreas that produce insulin-the beta cells-completely and perhaps irreversibly. The patient is then dependent on external sources of insulin for the rest of his or her life. The drug in the new study-a special monoclonal antibody, hOTK3-has been created precisely to interfere with the immune attack on the beta cells. The antibody binds to the CD-3 molecule on the surface of the immune cells involved in beta cell attack and thus neutralizes them. Temporarily freed from immune attack, the beta cells that have survived can continue to produce insulin naturally. Preliminary studies have shown that this neutralizing effect can last up to two years. Scientists hope to demonstrate now that it can be continued for much longer.

The study is designed for patients who have very recently been diagnosed with the disease. They will receive an initial dose of the experimental drug, and then after a year a second dose. If the medication is effective, as researchers expect, it will permit patients to be able to continue producing their own insulin long after type 1 diabetes would normally have made this impossible. According to Dr. Kevan Herold, from Columbia University, head of the nationwide project, this preservation of insulin function has enormous benefits.

"The ability to make any insulin at all on your own," Herold explains, "makes glycemic control much better. If you catch type 1 diabetes early enough you can affect metabolic control of the disease. This in turn leads to improved health and reduced risk of secondary complications. It is a very good prospect. And we hope to make it last forever."

Persons interested in finding out more about the study and in learning how they may enroll should contact the Hagopian Laboratory at PNRI 1-888-324-2140.