Idun Pharmaceuticals' Clinical Trial Demonstrates Safety Of Liver Disease Drug
- Phase I Trial Demonstrates Safety and Opens the Door To Treat Multiple Liver Diseases -
SAN DIEGO, Jan. 31 /PRNewswire/ -- Idun Pharmaceuticals, Inc. today announced the results of its Phase 1 clinical trial of IDN-6556. The drug was safe and well tolerated in a clinical study involving 50 normal adults. Evaluation of patients with mild hepatic impairment is ongoing. In the Phase 1 study, IDN-6556 was administered in both single doses and for a week of therapy with various doses. The drug was well tolerated in all groups of subjects.
``We are excited to have completed this Phase 1 stage of the drug's development,'' said Dr. David Shapiro, Chief Medical Officer and Executive Vice President at Idun. ``This drug may prove to be useful in multiple liver diseases and we will shortly start Phase 2 studies to evaluate its effects on different groups of hepatic patients. We will conduct Phase 2 trials of individuals with hepatitis C virus (HCV) infections, alcoholic liver disease and, subsequently, additional trials of individuals experiencing acute alcoholic hepatitis. HCV affects about 4 million Americans and another 200 million people worldwide. Acute alcoholic hepatitis is an often-lethal condition that affects about 85,000 people in the U.S. alone and for which there is no effective treatment. We believe that IDN-6556 can play an important role in the standard care for people with HCV, acute alcoholic hepatitis, and many other liver diseases.''
``There are literally more than a half-billion people in the world suffering with liver diseases that may benefit from this drug,'' added Dr. Steve Mento, Idun's President and CEO. ``The success of the Phase 1 trial of our caspase inhibitor is the first clinical step to a new and important therapy for patients with liver disease. It also validates Idun's approach to small molecule drug development and the role that apoptosis modulators can play in the treatment of a number of diseases. We've always believed that caspase inhibitors would be effective drugs for a number of diseases. IDN-6556 is the first broad-spectrum caspase inhibitor to be studied in humans.
``This is just the beginning of many exciting new opportunities that can come from Idun's technology. We have programs in earlier stages of development in cardiovascular disease, inflammation, central nervous system diseases, and cancer with just as much potential.''
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 normal physiological process mediated by a cascade of intra-cellular proteins. Too much, inappropriate, or too little apoptosis is believed to play a role in many important human diseases. Idun believes that controlling the cell death process will have utility in treating cancer, neurodegenerative diseases, ischemic disorders and cardiovascular disease. The company has adopted a commercialization strategy encompassing strategic collaborations with major pharmaceutical companies; internal, independent development of selected small molecule therapeutics; and out-licensing of diagnostics, gene therapies, and bioproduction technologies. Idun has an extensive patent portfolio covering the fundamental and core technologies involved in the regulation of cell death and has established partnerships with Abbott Laboratories in cancer, with Elan Corporation, plc in stroke, and Becton Dickinson and Company in research reagents. |
