Idun Pharmaceuticals Reports Positive Data for First Oral Clinical Trial in HCV Patients SAN DIEGO, Oct. 27 /PRNewswire/ -- Idun Pharmaceuticals, Inc. today announced positive data from its oral dose-ranging clinical trial of IDN-6556 for the treatment of liver impairment caused by Hepatitis C virus (HCV) infection. The data showed that when given orally, IDN-6556 normalized liver enzymes after just two weeks of twice-a-day dosing. Increased levels of aminotransferase enzymes are a well-accepted indicator of damage in the liver. As was seen in an earlier trial with an intravenous form of IDN-6556, the drug was safe and well tolerated, and did not appear to exacerbate the HCV infection. The data was presented by Paul Pockros, M.D., Head of the Division of Gastroenterology and Hepatology at Scripps Clinic (San Diego), at a late- breaking session of the 54th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston. "The data is encouraging," Dr. Pockros said. "Together with the other investigators in the trial, I believe the drug may be useful in treating a number of liver diseases and will be studied further in patients with HCV. The study is ongoing and we hope to present additional data next year on its effects in patients with other liver diseases, such as fatty liver disease (NASH) and hepato-biliary disease." IDN-6556 is a potent inhibitor of the key caspase enzymes that mediate apoptosis and is designed to protect liver cells (hepatocytes) from excessive programmed cell death. Increased rates of apoptosis have been implicated in many different liver diseases. Unfortunately, individuals suffering from these conditions have limited treatment alternatives, many of which are often poorly tolerated, expensive and do not cure most patients. The ongoing clinical trial is a double-blind, placebo-controlled, dose- ranging study being conducted at six major hepatology hospitals in the United States. The presentation was based on data from 41 patients, over 70% of whom had failed to have an adequate response with currently approved treatments of HCV (interferon-alpha and ribavirin). "The study shows that IDN-6556 can have beneficial effects in as little as two weeks in patients with HCV," said David Shapiro, M.D., Idun's Chief Medical Officer. "The data from this study in HCV-infected patients provides support for the evaluation of the drug in its oral form in other liver diseases as well. We are currently developing the plans for the next set of clinical studies in patients with HCV. We plan to study the effects of the drug in both patients that have failed to be successfully treated with the currently available drugs and, separately, with IDN-6556 given together with such therapy." "This data in humans is consistent with the results of extensive scientific research conducted by Idun and our collaborators," said Steven J. Mento, Ph.D., President and CEO of Idun. "It further supports our view that IDN-6556 may have a major impact on the treatment of a broad range of liver diseases and encourages us to proceed with an expanded development program." Idun also recently announced the initiation of another clinical trial of IDN-6556 in patients undergoing liver transplantation. Idun Pharmaceuticals, Inc. is a biopharmaceutical company located in San Diego, CA, creating innovative human therapeutics with a primary focus on controlling apoptosis, or programmed cell death. Apoptosis is a genetically controlled, normally occurring, biological process mediated by a cascade of intra-cellular proteins. Too much or too little apoptosis is believed to play a role in many important human diseases. Idun believes that its drug candidates will have utility in treating liver disease, inflammation, cancer, and cardiovascular disease. Idun has an extensive patent portfolio covering the fundamental and core technologies involved in the regulation of cell death. Some of the statements in this press release are forward-looking statements and do not guarantee future performance and involve risks and uncertainties. Actual results may differ substantially from the results that the forward-looking statements suggest for various reasons. These forward- looking statements are made only as of the date of this press release. DATASOURCE: Idun Pharmaceuticals, Inc. CONTACT: Steven J. Mento, Ph.D., President and CEO of Idun Pharmaceuticals, Inc., +1-858-623-1330, or Kathy Witz Sweeney of Mentus, +1-858-455-5500, x212, or , for Idun Pharmaceuticals Web site: http://www.idun.com/

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