Latest News

In April 2011, the FDA approved Rituximab (anti-CD20; Genentech) for use in granulomatosis and microscopic polyangiitis based on results from the ITN RAVE study. Before the Rituximab label extension, the standard of care for this disease was cyclophosphamide, a potent immunosuppressant that although effective is very toxic when used long-term. The RAVE study was able to successfully compare a potentially safer biologic therapy for a rare and challenging disease against the long-accepted standard of care treatment. Designing such a study required creative approaches which are described in the November 2011 publication in the Open Arthritis Journal, “Design of the Rituximab in ANCA-Associated Vasculitis (RAVE) Trial” (Specks et al.). In this paper, the authors “illuminate the unique challenges involved in comparing a new treatment approach against an entrenched standard of care.”

Richard Nash, MD (Colorado Blood Cancer Institute) will be presenting early results from the Immune Tolerance Network (ITN) HALT MS clinical trial on December 11, 2011 at the American Society of Hematology (ASH) annual meeting in San Diego, CA. The abstract is titled.

The Immune Tolerance Network's (ITN's) T1DAL research trial for recently diagnosed type 1 diabetes has recently received the approval of its Data Safety Monitoring Board (DSMB) to begin accepting patients in the younger cohort, ages 12-15 years, into the study. The decision was made after a review of safety data from the initial group of 10 adult-age subjects enrolled into the study. The trial is now open to individuals between the ages of 12-35 who have been diagnosed with type 1 diabetes within the past 3 months.

Data from an Immune Tolerance Network (ITN) hayfever pilot study will be presented at the World Allergy Congress on December 7, 2011 in Cancun, Mexico.

18-month data from the Immune Tolerance Network's (ITN’s) RAVE trial comparing rituximab (anti-CD20) against cyclophosphamide in ANCA-associated Vasculitis will be reported on November 8^th at the 2011 American College of Rheumatology (ACR) meeting in Chicago, IL.  Protocol Chair Ulrich Specks, MD (Mayo Clinic) will be presenting the following abstract.

The Immune Tolerance Network (ITN) is currently seeking Concept Proposals for novel clinical trials designed to induce immune tolerance in combined allogeneic solid organ transplantation plus therapeutic cell transfer.

The Immune Tolerance Network is conducting a portfolio of innovative intervention research trials in new-onset type 1 diabetes.

‍

The Immune Tolerance Network (ITN) today announced enrollment of the first participant in a phase II clinical research trial evaluating whether intramuscular injections of alefacept (Amevive®) halt or slow the destruction of insulin-producing beta cells in patients recently diagnosed with type 1 diabetes. The research trial, Inducing Remission in New-Onset Type 1 Diabetes with Alefacept (T1DAL), is seeking 66 eligible participants at approximately 15 clinical research centers nationwide.

The Immune Tolerance Network (ITN) today announced enrollment of the first patient in a phase II clinical trial evaluating the efficacy and safety of abatacept in adult patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis. The trial aims to enroll 123 eligible participants at 20 clinical research centers across the United States over the next two years.

The Immune Tolerance Network (ITN) today announced enrollment of 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.