InterMune Announces Start of Phase 1b Trial o...(C patients infected with HCV genotype 1 ...),Health

Date:9/26/2007

C patients infected with HCV genotype 1 will be studied. If the results of the first three dosage cohorts indicate that more information would be desirable to more fully inform the design of a planned study of ITMN-191 in combination with Pegasys(R) and ribavirin, the Phase 1b study will be expanded to include additional cohorts of treatment-naive patients.

Further Details on Phase 1a Study -- Safety and Pharmacokinetic Profile of ITMN-191

The Phase 1a placebo-controlled study of ITMN-191 was completed in May of 2007, enrolling a total of 64 healthy volunteers. Doses in this study ranged from less than 10% to many-fold higher than those that will be evaluated in the three dosage cohorts of the Phase 1b trial. The study results show that:

-- ITMN-191 was well tolerated in all doses evaluated in Phase 1a study.

-- No Serious Adverse Events (SAEs) were reported and no subject

discontinued the study due to an Adverse Event (AE).

-- All AEs in subjects receiving ITMN-191 were classified as mild (CTCAE

Grade 1).

-- The most common AEs reported were gastrointestinal-related and

consisted of mild diarrhea and mild abdominal pain. These mild AEs

occurred predominantly in the highest dose group, a dose many-fold

higher than the doses planned in the Phase 1b study just begun.

-- No clinically significant laboratory abnormalities or changes in

electro-cardiograms were observed.

-- Food has a significant effect on the absorption of ITMN-191, with

higher AUC in patients who took ITMN-191 with a meal.

-- The pharmacokinetics of ITMN-191 were linear over the range of doses

planned in the Phase lb study.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IP
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SOURCE InterMune, Inc. Copyright©2007 PR Newswire. All rights reserved

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