Andromeda Biotech Ltd., a subsidiary of Clal Biotechnology Industries Ltd., has dosed its first patient with DiaPep277 for the treatment of type 1 diabetes in its Extension Study to the phase III clinical trial DIA-AID 2. 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 DIA-AID 2 confirmatory study.
DIA-AID 2 is scheduled to be completed at the end of 2014. This extension study will be conducted in medical centres in the USA, 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 given quarterly for two additional years. The extension study is expected to be completed at the end of 2016.
This extension study is part of a clinical development plan which was presented to the regulatory authorities in Europe and in the USA.
Shlomo Dagan, CEO of Andromeda commented, “We are delighted to initiate a long term study in a large population which shows the confidence that patients have in being treated with DiaPep277. This is a major step forward in the clinical development pathway for DiaPep277, providing hope to patients who have been facing an unmet clinical need.”
DiaPep277, a unique peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60), was invented by Prof Irun Cohen and his team at the Weizmann Institute of Science. 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 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.
Andromeda Biotech Ltd. is focused on the development of an innovative treatment for autoimmune diabetes.