Andromeda Biotech Ltd. has announced that the European Medicines Agency, (EMEA), has accepted the clinical development plan for DiaPep 277, Andromeda’s lead product for the treatment of type 1 diabetes. The plan submitted by Andromeda includes conducting a confirmatory Phase III study to support the results from the ongoing current Phase III study and will recruit 450 newly diagnosed adult patients (ages 20-45) with type 1 diabetes. About 100 medical centers worldwide, in North America, Europe, South America, and Israel are planned to participate. The goal of the study is to evaluate the long term safety and treatment effect of DiaPep277 to preserve secretion of insulin in diabetic patients. The study will be double blinded with one treatment group and a placebo group. “With the support of the EMEA and following the completion of recruitment in the current ongoing Phase III clinical study, we are very encouraged and will be forging ahead with our clinical development plan in order to pave the way for the drug approval of DiaPep277,” said Dr. Shlomo Dagan, CEO of Andromeda. Andromeda has also submitted the clinical development plan for the Phase III confirmatory study to the FDA for their approval. The Phase III clinical study is scheduled to begin during the first half of 2010.
