patients lost to follow-up at the time of the week 72
-- On April 2, InterMune reported top-line results in the four dose
cohorts of treatment-naive patients chronically infected with
hepatitis C virus (HCV) genotype 1 in its Phase 1b multiple-
ascending-dose (MAD) monotherapy trial of ITMN-191:
-- Day 14 median viral kinetic results competitive with those
published for other direct antiviral compounds when used in
monotherapy for 14 days. Specifically, InterMune reported a
median 3.8 log reduction (equal to 99.98% reduction) in HCV RNA
from baseline at Day 14;
-- Significant and rapid viral kinetic activity when dosed every
12 hours; and
-- Excellent safety and tolerability in all dosage regimens.
-- InterMune reported successful completion of 13-week toxicology
studies in rats and monkeys at exposures higher than those expected
to be evaluated in clinical studies. These preclinical studies were
required before initiating the Phase 2 program of ITMN-191 which
will involve durations of therapy longer than those studied in Phase
-- Announced on May 29 the initiation of a 14-day study of ITMN-191 in
combination with Pegasys(R) (pegylated interferon alpha-2a) and
Copegus(R) (ribavirin). The study is proceeding as planned.
-- Submitted several abstracts for possible presentation at the 59th
Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD) to be held October 31 - November 4, 2008 in San
Francisco, including but not limited to data on ITMN-191.
-- On June 24, InterMune exchanged $85 million
|SOURCE InterMune, Inc.|
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