The goal of the randomized, placebo-controlled DEFEND-1 trial was to evaluate the safety and efficacy of otelixizumab in preserving beta cell function and maintaining insulin production in these individuals.
Tolerx and GSK are currently reviewing the data from the DEFEND-1 trial to better understand the outcome and determine next steps. According to the companies, no new or unexpected treatment-related safety concerns emerged during the DEFEND-1 study. GSK will continue to explore additional dosing regimens to inform decisions about the future clinical development program for otelixizumab.
Tolerx is suspending recruitment and dosing of its DEFEND-2 trial, a confirmatory Phase III study of otelixizumab similar in trial design to DEFEND-1, pending review of the DEFEND-1 results.
JDRF will continue to report on ongoing developments as information becomes available.
To access the announcement from Tolerx, please click here.
About the DEFEND-1 Study
DEFEND-1 is a randomized, placebo-controlled Phase III study of 272 patients, age 12 to 45, with new-onset type 1 diabetes. DEFEND-1 was conducted at over 100 study centers throughout North America and Europe. The study was designed to evaluate whether a single 8-day intravenous course of otelixizumab (3.1mg), administered not more than 90 days after the initial diagnosis of autoimmune type 1 diabetes, preserved the function of insulin-producing beta cells in the pancreas, as measured by C-peptide. Measurement of C-peptide (a protein that shows how much insulin the body is producing) at 12 months after dosing was the primary endpoint in DEFEND-1 and is a well established surrogate measure of beta cell function and a recommended endpoint by the U.S. Food and Drug Administration (FDA) and the American Diabetes Association.
JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder and advocate of type 1 research. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is a disease which strikes children and adults suddenly and requires multiple injections of insulin daily or a continuous infusion of insulin through a pump. Insulin, however, is not a cure for diabetes, nor does it prevent its eventual and devastating complications which may include kidney failure, blindness, heart disease, stroke, and amputation.
Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.4 billion to diabetes research, including more than $100 million last year.
For more information, please visit http://www.jdrf.org/