YAVNE, Israel, May 28, 2012 (GLOBE NEWSWIRE) -- Andromeda Biotech Ltd. today announces that the US Food and Drug Administration (FDA) granted Orphan Drug designation for DiaPep277® for the treatment of type 1 diabetes (T1D) patients with residual beta cell function.
The designation of Orphan Drug status offers 7 years marketing exclusivity from the time of approval. In addition, this may present other benefits such as tax incentives, reduced user fees, and assistance for the registration process.
DiaPep277® is currently in Phase III clinical studies. A first study, which was conducted in Europe, South Africa, and Israel, met its primary endpoint based on initial results. A global confirmatory Phase III study is now being conducted in more than 120 medical centers.
Shlomo Dagan commented, "This is a significant milestone for the company giving us recognition and confidence following the long path in the development process. We believe in the potential of the product to benefit type 1 diabetes patients, thus providing incentive to pursue such a therapy to address the current clinical unmet 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 T1D 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., 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 T1D.
For more information about Andromeda Biotech, please visit our site: (www.andromedabio.com)
CONTACT: Shlomo Dagan, PhD CEO Andromeda Biotech Ltd. Phone: +972 8 9387777 E-mail: email@example.com