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 centers in the
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
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
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Shlomo Dagan, PhD CEO Andromeda Biotech Ltd.Phone: +972 8 9387777 E-mail: email@example.com