Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.InterMune has reported the positive top-line results from the four dose cohorts of treatment-naive patients in its ongoing Phase Ib clinical trial of ITMN-191, designated R7227 at Roche.
Subscribe to our email newsletter
ITMN-191 was administered as monotherapy in patients with chronic hepatitis C virus (HCV) genotype 1 infection. InterMune reported that treatment with ITMN-191 resulted in rapid and significant reductions in HCV RNA. Based on a preliminary review of the available and still blinded clinical data from the four completed cohorts of the Phase Ib study, ITMN-191 was found to be safe and well-tolerated. One final cohort consisting of treatment-experienced patients dosed at 300mg every 12 hours will begin dosing next week.
InterMune has reported that clinical trial authorization applications related to its 14-day triple combination study of ITMN-191 with Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin) were submitted to the relevant European regulatory authorities in March, 2008.
InterMune also successfully completed a 13-week chronic toxicology study in monkeys, which supports the intended longer duration of dosing of ITMN-191 planned in the Phase II clinical development program, to be conducted by Roche. Roche has completed development of the tablet formulation of ITMN-191 that will be used in the Phase II program.
Dan Welch, president and CEO of InterMune, said: “With our partner Roche, we plan to initiate in this quarter a 14-day triple combination therapy trial with Pegasys and Copegus. We also are exploring the combination of ITMN-191 with other small molecule compounds.”