Andromeda Begins Dosing in Diabetes Extension Study

Andromeda Biotech has dosed the first patient in its extension study of its Phase III DIA-AID 2 trial of DiaPep277 for the treatment of type 1 diabetes. The open-label, 24-month extension study is designed to evaluate long-term safety, tolerability, and the effect of DiaPep277 on the ability of patients to maintain glycemic control for two additional years following the completion of the confirmatory study, which is expected to conclude at the end of 2014. The extension study will be conducted in medical centers in the U.S., Europe, and Israel.

Patients who are eligible to be enrolled in the extension study are those who have completed two years of treatment in the DIA-AID 2 trial and have residual beta cell function (stimulated C-peptide not less than 0.2 nmol/L) regardless whether they were on the actual drug or on the placebo.

All eligible patients will be treated with subcutaneous injections of 1 mg of DiaPep277(R) given quarterly for two additional years. The extension study is expected to be completed at the end of 2016.

DiaPep277 is a unique peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60). The peptide acts by modulating the immune system, thus preventing the destruction of pancreatic cells that secrete insulin and preserving their natural function. Treatment of type 1 diabetes patients with DiaPep277(R) may have several medical benefits including slowing the deterioration of the disease, improved metabolic control, reduction of daily insulin dose requirements, and reduction of diabetic complications.