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New Drug for For Liver Transplantation
  (Press Release)
SAN DIEGO, Oct. 8, 2003 /PRNewswire/ -- Idun Pharmaceuticals, Inc.today announced that it has initiated a Phase 2 clinical trial ofIDN-6556 in patients undergoing liver transplantation. IDN-6556 isdesigned to protect liver cells from excessive programmed celldeath, also known as apoptosis. The study will evaluate if IDN-6556can decrease the cellular liver damage that can occur during thetransport and transplant periods. In the study, the drug will beadministered to the donor liver during transport to the transplantcenter, as well as to the liver recipient. The study was initiatedat Mayo Clinic in Rochester, MN, which is the first of twelveleading transplant hospitals that are expected to participate inthe approximately 100 patient clinical trial.
"While there are approximately 5,000 liver transplants performedeach year in the United States, there are over 17,000 patients onthe waiting list for a transplant," according to Gregory Gores,M.D., Professor of Medicine at the Mayo Clinic and ResearchFoundation and a principal investigator in the study. "There is anenormous need for additional therapies that may allow an increasednumber of organs to be transplanted. I have conducted severalpre-clinical studies in models of liver transplantation withIDN-6556 and it has exhibited very beneficial effects. We hope tosee the same sort of benefits in this patient group."
"We are excited to initiate this very important study," said DavidShapiro, M.D., Idun's Chief Medical Officer. "We believe that thedrug has considerable potential in treating several hepaticdiseases and feel that liver transplantation offers the fastestroute to clinical proof of efficacy and ultimately, regulatoryapproval."
IDN-6556, given orally, is currently being studied in a Phase 2human clinical trial in several groups of patients, initially thosewith hepatitis C virus who have failed to respond to existingdrugs. Idun recently announced that the Food and DrugAdministration granted orphan drug designation for the use of thedrug in liver and other solid organ transplant patients.
Idun Pharmaceuticals, Inc. is a biopharmaceutical company locatedin San Diego, CA, creating innovative human therapeutics with aprimary focus on controlling apoptosis, or programmed cell death.Apoptosis is a normally occurring biological process mediated by acascade of intra-cellular enzymes. Too much or too little apoptosisis believed to play a role in many important human diseases. Idunbelieves that its drugs will have utility in treating liverdisease, inflammation, cancer, and cardiovascular disease. Idunhas an extensive patent portfolio covering the fundamental and coretechnologies involved in the regulation of cell death.
Some of the statements in this press release are forward-lookingstatements and do not guarantee future performance and involverisks and uncertainties. Actual results may differ substantiallyfrom the results that the forward-looking statements suggest forvarious reasons. These forward-looking statements are made only asof the date of this press release.
Idun Pharmaceuticals, Inc.Web site: http://www.idun.com
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