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InterMune Presents Research on ITMN-191 in Hepatitis C at Digestive,Disease Week Meeting

observed with covalent protease inhibitors currently in development. The immediate onset of inhibition and slow dissociation observed with ITMN-191 suggest that liver concentrations may underestimate its antiviral activity, since ITMN-191 will likely remain bound to the protease target after unbound drug is cleared from the liver."

About ITMN-191

Preclinical toxicology and pharmacokinetic studies in multiple species suggest that ITMN-191 has attractive characteristics, including significant liver exposure, slow dissociation from the NS3/4 protease, high in vitro potency and specificity, and an advantageous cross-resistance profile, including considerable effectiveness against variants of the NS3/4A protease that are resistant to other HCV protease inhibitors currently in development. The preclinical pharmacokinetic results support the exploration of twice-daily oral dosing. In early May 2007, InterMune reported that it had completed dosing in a Phase 1a single ascending-dose (SAD) trial of ITMN-191 in healthy subjects. No serious adverse events were reported in the SAD trial. Preliminary safety data from the SAD trial suggests that ITMN-191 was well tolerated and safe at the doses intended for the Phase 1b multiple-ascending dose (MAD) trial of ITMN-191. InterMune currently anticipates that the MAD trial will begin in the third quarter of 2007 and initial top-line viral kinetic data reported in the fourth quarter of 2007. InterMune and Roche have a collaboration agreement for the research, development and commercialization of ITMN-191 (referred to as R7227 within the Roche research and development programs) and second-generation HCV protease inhibitor compounds.

About HCV and HCV Protease Inhibitors

According to the Centers for Disease Control and Prevention (CDC), an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected. It is estimated that there are 170 million people worldwid
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