Idun Pharmaceuticals Reports Positive Data for First Oral Clinical Trial in HCV Patients
October 27 2003 - 2:00PM
PR Newswire (US)
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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