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The T1DAL ITN045AI clinical research study for recently diagnosed type 1 diabetes has completed enrollment at 19 clinical centers across the U.S. T1DAL is a randomized, placebo-controlled research study for participants between the ages of 12-35 and recently diagnosed with type 1 diabetes. The goal of this trial is to determine whether the drug alefacept (Amevive ®) can delay or permanently halt the destruction of beta cells in new-onset type 1 diabetes. If the destruction of the beta cells is stopped, the body might be able to produce insulin on its own longer, which could stop or slow progression of the disease.

This World Asthma Day 2012, NIH renews its commitment to working with individuals, families and healthcare professionals to reduce the worldwide burden of asthma. We commend the NIH-supported investigators who continue to make significant progress in asthma research, and we express our gratitude to the people who have participated in NIH-sponsored asthma research studies, as well as to the organizations that provide support for those affected by this disease.

Results from the ITN020AI STAyCIS study, testing atorvastatin therapy in early multiple sclerosis, were just published in Neurology. The study, led by Scott Zamvil, MD (University of California, San Francisco), evaluated the safety and efficacy of atorvastatin (Lipitor®, Pfizer) in subjects with early signs that often lead to multiple sclerosis (MS), termed clinically isolated syndrome (CIS). Previous preclinical studies demonstrated the ability of statins to reduce disease activity in MS models. This study was the first to test whether statin medication alone reduces the risk of conversion to MS in at-risk CIS patients.

The ITN043AD GRASS study for hay fever sufferers, conducted by Dr. Stephen Durham at Imperial College in London, recently achieved a milestone by completing randomization of 106 study participants. The goal of the GRASS study is to compare the ability of two currently approved forms of immunotherapy treatment for hay fever, Grazax® (sublingual) and Alutard SQ® (subcutaneous), to potentially induce tolerance. Inducing tolerance could reduce the symptoms of hay fever, decrease the need for anti-allergy rescue medication and improve quality of life in hay fever sufferers.

The ITN524ST-CTOT12 ARTIST study on renal transplantation and the Immune Tolerance Network (ITN) signature of tolerance, recently met the target enrollment of 250 participants. This collaborative study between the Immune Tolerance Network (ITN) and the Clinical Trials in Organ Transplantation (CTOT) consortium, led by Drs. Kenneth Newell (Emory University), Laurence Turka (Harvard University), and Anil Chandraker (Brigham and Women’s Hospital), is an observational study for people who received a kidney transplant within the past 1 to 5 years.

Data from Immune Tolerance Network (ITN) mechanistic work will be reported at the upcoming American Academy of Allergy, Asthma, and Immunology (AAAAI) meeting on March 2-6 in Orlando, FL.

The Immune Tolerance Network (ITN) is currently seeking short “Concept Proposals” for novel combination therapy clinical trials designed to induce immune tolerance in allergy and asthma. The ITN is especially interested in the following.

The ITN has invited two formal applications to be vetted by the ITN’s Network Steering Committee in April 2012 as a result of an RFP process yielding numerous high-quality submissions. This past summer the ITN issued a Request for Proposals (RFP) for clinical trials designed to induce tolerance using combined therapeutic cell transfer and solid organ transplantation. This RFP was an effort to corral innovative strategies from the transplant community to identify novel and promising clinical trials to further explore the use of mixed chimerism as a tolerance induction strategy.

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In a study recently published in PLoS ONE, researchers used specimens from the ITN RAVE trial to investigate angiopoietin-2 as a potential biomarker in ANCA-associated vasculitis (AAV), a highly variable and serious disease without reliable markers to help predict disease outcome.

Results from an ITN study published today in the Journal of the American Medical Association demonstrated successful weaning of anti-rejection drugs in pediatric liver transplant recipients (results here).  Results from this multicenter pilot study, led by Sandy Feng, MD, PhD (University of California, San Francisco), suggest that certain children undergoing liver transplantation from a parental living donor may be able to maintain their organ without the burdens of lifetime immunosuppression.