Idun Pharmaceuticals Announces Results of Successful Phase 1 Clinical Trial
- First Trial Shows Improvements in Liver Enzymes With IDN-6556 -
SAN FRANCISCO, May 20 /PRNewswire/ -- Idun Pharmaceuticals, Inc. presented positive results of its Phase 1 clinical trial of IDN-6556 yesterday at the Digestive Disease Week 2002 conference in San Francisco. The drug was safe and well tolerated in the clinical study involving 76 normal adults and patients with mild liver impairment. Statistically significant and clinically relevant improvements in liver enzymes were seen in the patients with mild liver impairment treated with IDN-6556. These patients included individuals with stable hepatitis C virus (HCV) infection. Idun plans to study IDN-6556 in larger Phase 2 clinical trials in patients with HCV infection and acute alcoholic hepatitis.
IDN-6556 is the first broad-spectrum caspase inhibitor to be studied in humans and acts to preserve the structure and function of cells under stress. The liver damage seen with HCV infection results from the body's defense mechanisms and apoptosis is involved in this process. While IDN-6556 is not an anti-viral drug and will not cure patients of the viral infection, it is thought that treatment of infected patients with IDN-6556 may preserve the cells of the liver and help them to maintain their normal liver function and health.
"There is a considerable and growing need for additional drugs to treat numerous liver diseases. We believe that the protective effects that we have seen with this drug will be useful in several liver diseases," said Dr. David Shapiro, Chief Medical Officer and Executive Vice President at Idun. "Based on the number of people affected, the market potential for this drug is huge and includes hepatitis B virus infection, an enormous medical problem, particularly in Asia."
HCV affects about 4 million Americans and 200 million people worldwide. In spite of progress in treating HCV with interferon and ribavirin, a very large group of patients do not achieve a sustained viral response with treatment. There is a continuing need for additional therapy for these patients who will comprise the largest growing group of HCV patients in the USA this decade. Acute alcoholic hepatitis is an often-lethal condition that affects about 85,000 people in the U.S. alone, is fatal in up to 50% of cases, and for which there is no approved treatment. The disease is mediated by apoptosis, which may be reversed by IDN-6556.
"These data validate Idun's approach to small molecule drug development and the role that apoptosis modulators can play in a number of diseases," added Dr. Steve Mento, Idun's President and CEO. "With the beneficial effects on liver enzymes seen in this first trial, we are very interested in conducting clinical trials of IDN-6556 in several liver diseases. We believe that this drug has considerable promise to help numerous patients with liver disease and are very excited by the prospects for the drug."
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.
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.
SOURCE: Idun Pharmaceuticals, Inc. |
