Tolerion reports Phase II data for Type I diabetes vaccine

Tolerion Inc. (Portola Valley, Calif.) said all doses of once-weekly intramuscular TOL-3021 for 12 weeks improved C-peptide levels, a marker of pancreatic beta cell function, relative to placebo in a Phase II trial to treat Type I diabetes. TOL-3021 also significantly reduced the number of proinsulin-reactive CD8 T cells vs. placebo (p<0.006) without affecting T cells against unrelated islet or foreign molecules. Additionally, TOL-3021 led to no significant changes in interferon (IFN) gamma, IL-4 or IL-10 production in CD4 T cells. The blinded, dose-escalation trial enrolled 80 adult Type I diabetics to receive placebo or 0.3, 1, 3 or 6 mg TOL-3021 for 12 weeks. Data were published in Science Translational Medicine.

Tolerion said it is in the process of planning a larger trial that will evaluate TOL-3021 dosed for more than 12 weeks, but declined to disclose a time frame for when the trial will start. The company also said it plans to assess whether TOL-3021 can slow or stop disease progression entirely in younger Type I diabetics when administered before large numbers of beta cells have been destroyed. ...