The ITN’s LEAP study won the Society for Clinical Trials David Sackett Trial of the Year Award for 2015. This award goes to a randomized clinical trial published in the previous year that supports substantial change in healthcare, reflects excellent methodology, and overcomes obstacles in implementation. Congratulations to the LEAP team for this recognition!
Two-year data from the ITN’s START Trial (Study of Thymoglobulin to ARest T1D) found that antithymocyte globulin (ATG) did not preserve insulin production in the majority of type 1 diabetes patients, but did show benefit in a subset of older participants. The results were published recently in Diabetalogia.
The Immune Tolerance Network completed enrollment for the PAUSE psoriasis study with 108 participants. Led by Dr. James Krueger at the Rockefeller University, the PAUSE Study is testing the combination of two biologics, ustekinumab (Janssen Biotech, Inc.) and abatacept (Bristol-Myers Squibb), in psoriasis patients.
Protection against peanut allergy by early consumption persists following a one-year period of peanut avoidance
The Immune Tolerance Network’s (ITN) LEAP-ON clinical trial has found that peanut allergy prevention achieved from early peanut consumption in at-risk infants persists after a one-year period of avoiding peanut. LEAP-ON (Persistence of Oral Tolerance to Peanut) was led by Dr. Gideon Lack from Kings College London and the results were published today in the New England Journal of Medicine.
The ITN’s LEAP and HALT-MS trials were two of the 15 highlighted topics in NIAID’s selected research advances for 2015. In his opening remarks, NIAID Director Tony Fauci explains that this selection includes “notable scientific advances made by NIAID researchers and NIAID-funded scientists” and “are representative of how public investment in biomedical research drives scientific progress and benefits human health.”
A manuscript published in the November 25, 2015 online issue of Science Translational Medicine reported no serious adverse reactions in the first phase 1 safety trial of a new immunotherapy approach investigating regulatory T cells (Tregs) for the treatment of type 1 diabetes (T1D). The clinical study was conducted at UCSF by Stephen E. Gitelman, MD, and Kevan C. Herold, MD, and was designed and analyzed by Jeffrey A. Bluestone, PhD.
The ITN is currently seeking proposals for clinical tolerance trials in solid organ transplantation. We are interested in trials using cell therapy to acheive tolerance in solid organ (liver and kidney) transplant. The ideal proposal should have a testable mechanism of tolerance induction and a strategy for assays to investigate this mechanism.
The Immune Tolerance Network (ITN) opened the OPTIMAL Study for liver transplant recipients at the first clinical site, the University of California, San Francisco on Monday, October 26, 2015. The OPTIMAL Study (Operational Tolerance Biomarkers of Immune Senescence and Lymphocyte Exhaustion Following Adult Liver Transplantation) will enroll 60 adult liver transplant recipients.
A potential biomarker of tolerance in kidney transplant recipients was found to be stable for up to three years in a cohort of 32 operationally tolerant kidney recipients from the ITN’s FACTOR study. The signature is characterized by the increased expression of two genes associated with B cells, suggesting a potential role of B cells in regulating the immune response to the kidney.