Disappointing news from GSK and Tolerx today as they announced that their Defend-1 clinical trial didn’t meet its goals.
These companies were looking to see if a protein called otelixizumab could help individuals who had just been diagnosed with type 1 diabetes. In this clinical trial, called Defend-1, adult patients diagnosed with type 1 diabetes were given an 8-day course of the protein shortly after diagnosis. Twelve months later, these patients were analyzed to see if the treatment had helped increase something called c-peptide, which is an indicator of insulin production. Unfortunately, they didn’t find that the treatment increased the level of c-peptide at all.
There’s a followup to this trial (cleverly called Defend-2) that has been suspended while further analysis of the data is going on. (More information at the xconomy website here.)