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News Release

RETAIN Trial for Newly Diagnosed Type 1 Diabetes Enrolls Patients

Immune Tolerance Network study will examine effect of anti-inflammatory drug

BOSTON and SEATTLE – March 2, 2011 – The Immune Tolerance Network (ITN) has enrolled the first participant in a two-part, phase II clinical research trial evaluating the effect of intravenous alpha 1-antitrypsin (AAT) on preserving the function of insulin-producing cells in patients recently diagnosed with type 1 diabetes. ARALAST NP is one marketed formulation of AAT. The Research Trial of ARALAST NP in New-onset Type 1 Diabetes (RETAIN) is seeking 82 eligible participants at 15 clinical research centers across the U.S. The first participant was enrolled at Emory University/Children’s Hospital of Atlanta.

The RETAIN trial is being conducted by the ITN, and supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and by the Juvenile Diabetes Research Foundation (JDRF). Additional funding for the study is provided by the Special Statutory Funding Program for Type 1 Diabetes Research, a special appropriation for research on the prevention and cure for type 1 diabetes. Baxter Healthcare Corporation is providing the ARALAST NP supply for the study.
 
Type 1 diabetes is a chronic autoimmune disease. It develops when the T cells of the immune system mistakenly attack and destroy the body’s own insulin-producing beta cells in the pancreas. The body uses insulin to maintain normal levels of blood glucose.

“This is an exciting time for autoimmune disease research—particularly in type 1 diabetes,” said Gerald Nepom, M.D., director of the ITN. “The ITN’s mission is to conduct innovative, high impact studies in hopes of improving therapy and gaining a better understanding of the mechanisms of immune function and disease pathogenesis. Concepts of immune tolerance have become much more sophisticated but translating them into therapeutic success is a daunting challenge.” Nepom also pointed out that “research trials like RETAIN are very important because new therapeutic options for recently diagnosed type 1 diabetes patients are urgently needed to attempt to stop the disease process.”

The RETAIN trial is evaluating the ability of ARALAST NP (from Baxter Healthcare Corporation) to halt the progression of type 1 diabetes. ARALAST NP is an anti-inflammatory drug and an inhibitor of a class of enzymes called serine proteinases, which break down protein molecules. The drug may also affect immune cells that are involved in the development of type 1 diabetes. Other investigators have already shown that AAT can reverse new-onset diabetes in non-obese diabetic mice and inhibit the rejection of transplanted islet cells in animal models of diabetes.

“We are very excited that after two years of planning, we can begin our study to determine if AAT can slow the progression of newly diagnosed type 1 diabetes,” said Gordon Weir, M.D., the principal investigator of the RETAIN trial.

“The FDA approved this drug class more than 20 years ago,” added Weir, who is co-head of the section on Islet Cell & Regenerative Biology at Joslin Diabetes Center and Professor of Medicine at Harvard Medical School. “Although it has never been tested in patients with diabetes, previous studies have shown that ARALAST NP is very effective in animals with this disease.” If the drug is found to be effective in patients with diabetes, they may require less injected insulin and their blood glucose levels may be easier to control, thus leading to fewer long-term complications.

RETAIN is a two-part phase II clinical trial. In Part I, all participants will know they are receiving ARALAST NP, which will be tested to see if it is safe and well tolerated for those with new-onset type 1 diabetes. After Part I is completed, enrollment in Part II will begin. Participants in Part II will be assigned randomly to one of two groups, one to receive the drug and the other to receive a placebo.

The RETAIN trial is currently seeking participants between the ages of 16 to 35 years old who have been diagnosed with type 1 diabetes mellitus within three months of enrollment in the trial. Eventually, the enrollment age will be expanded to include children between 8 and 15 years old. Enrollment is expected to continue for approximately two years.

More information about the trial and participating clinical research centers can be found at www.retainstudy.org or www.clinicaltrials.gov.

• Joslin Diabetes Center; Boston, MA
• Naomi Berrie Diabetes Center at Columbia University; New York, NY
• Barbara Davis Center for Childhood Diabetes at University of Colorado Denver; Aurora, CO
• Nationwide Children’s Hospital; Columbus, OH
• Pacific Northwest Research Institute at University of Washington; Seattle, WA
• Massachusetts General Hospital; Boston, MA
• Yale University; New Haven, CT
• Children’s Hospital of Philadelphia; Philadelphia, PA
• University of California San Diego / Rady Children’s Hospital; San Diego, CA
• University of Massachusetts Medical Center; Worcester, MA
• Children’s Mercy Hospital; Kansas City, MO
• University of Maryland Medical Center; Baltimore, MD
• Emory University/ Children’s Hospital of Atlanta; Atlanta, GA
• Atlanta Diabetes Associates; Atlanta, GA
• University of Iowa; Iowa City, IA

About the Immune Tolerance Network

The Immune Tolerance Network is an international consortium of doctors, scientists, government officials and support staff dedicated to finding new, safer treatments for diseases and conditions affecting the immune system.
Funded by the National Institute of Allergy and Infectious Diseases and the Juvenile Diabetes Research Foundation International, the ITN develops and conducts clinical studies of immune tolerance therapies—highly targeted treatments designed to prevent disease-causing immune responses, without compromising the natural protective properties of the immune system. For more information about the ITN, visit www.immunetolerance.org