Alefacept: Phase II data

Researchers at Indiana University and colleagues reported data from the double-blind, U.S. Phase II T1DAL1 trial in 49 evaluable patients with newly diagnosed Type I diabetes showing that once-weekly 15 mg intramuscular alefacept given as two 12-week courses separated by a 12-week pause missed the primary endpoint of improving mean 2-hour C-peptide AUC from baseline to 12 months vs. placebo. Specifically, alefacept increased mean 2-hour C-peptide AUC by 0.015 nmol/L vs. a reduction of 0.115 nmol/L for placebo (p=0.065). Alefacept met the secondary endpoints at 12 months of improving mean 4-hour C-peptide AUC (increase of 0.015 nmol/L vs. a reduction of 0.156 nmol/L, p=0.019), reducing daily insulin use (0.36 vs. 0.48 units per kg per day, p=0.02) and reducing the mean rate of hypoglycemic events (10.9 vs. 17.3 events per person per year, p<0.0001) vs. placebo. Mean HbA1c levels at 12 months were not significantly different between treatment groups (p=0.75). The researchers concluded that alefacept could be useful to preserve beta cell function in patients with newly diagnosed Type I diabetes. Data were published in The Lancet Diabetes & Endocrinology. The trial was funded by NIH's National Institute of Allergy and Infectious Diseases (NIAID) and the Juvenile Diabetes Research Foundation (JDRF). ...