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InterMune Presents Research on ITMN-191 in Hepatitis C at EASL,Annual Meeting

tors and interferons, and discovering important insights into possible treatment regimens for chronic hepatitis C," said Lawrence M. Blatt, Ph.D., Chief Scientific Officer of InterMune. "We anticipate that treatment regimens will involve multiple agents, and we are hopeful that these combinations will lead to improved, sustained virologic responses for patients who are in need of more optimal therapies."

The third presentation concerned NS3 sequence variations in HCV replicons after exposure to ITMN-191 at clinically relevant concentrations. The NS3 sequence was found to undergo dynamic changes when exposed to increasing concentrations of ITMN-191. As was seen in previous work, substitution at position 168 of NS3 appears to be fundamental to resistance but alone is not sufficient for HCV replicon persistence at all ITMN-191 concentrations achieved in the liver of animal species following oral dosing. This suggests that the genetic barrier to resistance in patients following clinical dosing of ITMN-191 may be significant dependent upon human liver exposure.

InterMune currently is conducting a Phase 1a clinical study of ITMN-191 for the treatment of chronic HCV. Preclinical toxicology and pharmacokinetic studies in multiple species demonstrated that ITMN-191 has a favorable toxicology profile, significant liver exposure, 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. 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.

According to the Centers for Disease Control and Prevention (
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