Rituximab: Phase II data

Data from a double-blind Phase II trial in 87 patients with Type I diabetes showed that at 1 year post-first infusion, rituximab met the primary endpoint of achieving significantly higher mean AUC levels of C-peptide during the first 2 hours of a mixed-meal tolerance test vs. placebo (p=0.03). Rituximab also led to significantly lower glycated HbA1c and required doses of insulin vs. placebo over 12 months (p<0.001 for both). Patients received rituximab or placebo on days 1, 8, 15 and 22 of the study. Data were published in the New England Journal of Medicine.

Rituxan is approved to treat non-Hodgkin's lymphoma (NHL). The drug is also approved to treat rheumatoid arthritis in combination with methotrexate in the U.S. and chronic lymphocytic leukemia (CLL) in combination with chemotherapy in the EU. ...