Phase II study of vaccine TOL 3021 (Tolerion) demonstrates potential against Type 1 Diabetes

Results from a Phase II trial demonstrating that a genetically engineered vaccine TOL 3021, from Tolerion, may have the potential to alleviate or even shut down the destructive disease process in type 1 Diabetes. The study demonstrated that TOL 3021 preserved pancreatic beta-cell function while reducing destructive disease-specific T-cell activity in patients with Type 1 Diabetes. The trial was a randomized, blinded, placebo-controlled, dose escalation trial in 80 adults. Patients received one of four doses of TOL 3021 as an injection once a week for 12 weeks.

The data indicate that TOL 3021 was safe and well-tolerated, with no serious adverse events and no increase in adverse events overall compared to placebo. Additionally, levels of C-peptide were increased in all vaccine groups compared to the placebo group. Participants who received vaccine injections also exhibited fewer numbers of T cells. Results were reported in Science Translational Medicine: "Plasmid-Encoded Proinsulin Preserves C-Peptide While Specifically Reducing Proinsulin-Specific CD8 T Cells in Type 1 Diabetes," BO Roep et al. Science Translational Medicine, 26 June 2013, Vol 5 Issue 191,191ra82