Andromeda Biotech Initiates DIA-AID 2, a Confirmatory Phase 3 Study using DiaPep277®, for the Treatment of Type 1 Diabetes
Yavne, Israel, May 31, 2010: Andromeda Biotech Ltd. today announces the initiation of its’ confirmatory phase III clinical study, DIA-AID 2 using DiaPep277®, Andromeda’s lead product for the treatment of type 1 diabetes.
Enrollment of patients has begun in the US as part of a global trial which will be conducted at 100 medical centers in North America, Europe, and Israel.
This confirmatory study will include 450 newly diagnosed type 1 diabetes patients 20-45 years of age. The study is double-blind, placebo-controlled with a treatment period of 24 months. The main goal of the study is to maintain the ability of the pancreas to secrete insulin in patients who receive treatment with DiaPep277® compared to the placebo group.
Shlomo Dagan, CEO of Andromeda commented, “We are very pleased to achieve this important milestone as part of our clinical development plan for DiaPep277®, which was accepted by the EMA and the FDA. Notably, the success of this study will enable us to obtain marketing approval of the drug in Europe and the USA.”
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 to treat 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 targeted to treat newly diagnosed Type 1 diabetes adult patients with residual insulin secreting cells. Other potential target populations are children with Type 1 diabetes, patients with a high risk of developing 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) or contact:
Andromeda Biotech Ltd.
Phone: +972 8 938 7777