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Andromeda Biotech receives EMEA support for the clinical development plan of its lead product
Andromeda Biotech receives EMEA support for the clinical development plan of its lead product, DiaPep277, for the treatment of type 1 diabetes
Yavne, Israel, November 23rd, 2009: Andromeda Biotech Ltd. announces that the European Medicines Agency, (EMEA), accepts 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. About Andromeda Biotech Andromeda Biotech Ltd., a subsidiary of Clal Biotechnology Industries Ltd. (TASE: CBI), is focused on the development of an innovative treatment for autoimmune diabetes. Andromeda’s DiaPep277, currently in Phase III Clinical Studies, is a novel therapeutic approach in treating Type 1 diabetes. It is a unique peptide derived from the human protein, HSP60, which immunomodulates the immune system, prevents the destruction of pancreatic cells that secrete insulin and preserves their natural function. To date, there is no therapy capable of preventing the destruction of insulin secreting beta cells. Initially, DiaPep277 is designed to treat newly diagnosed Type 1 diabetes adult patients with residual insulin secreting cells. Other potential target populations are Type 1 diabetic children, patients with high risk of Type 1 diabetes and Type 1 diabetes patients with slow progressing disease. Type I diabetes affects approximately 1% of the world’s population and the potential drug market for DiaPep277 is estimated by the company to be more than half a billion dollars per year. For more information about Andromeda Biotech please visit our site: (www.andromedabio.com) Media Contact: Yamit Nissanov, PR for Andromeda Biotech, +972-9-9514666, +972-52-5541810, yamit@idancom.com
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