- Reports Further Details from Phase 1a SAD Clinical Study -
BRISBANE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) announced that the company has begun dosing the first patients in their Phase 1b multiple ascending dose (MAD) clinical trial evaluating ITMN-191 (also called R7227) in patients with chronic hepatitis C. ITMN-191 is a hepatitis C virus (HCV) protease inhibitor in development by InterMune and its partner, Roche. InterMune also reported additional information from its recently completed Phase 1a clinical trial of ITMN-191.
Dan Welch, President and Chief Executive Officer of InterMune, said, "We are pleased to have successfully initiated the very important Phase 1b multiple ascending dose study of ITMN-191." Mr. Welch continued, "This is our first opportunity to evaluate the effects of ITMN-191 on viral kinetics in HCV patients, and to gather additional safety information beyond the recently completed Phase 1a SAD study. We look forward to sharing top-line results from the three treatment-nave dose cohorts of the Phase 1b study in the first quarter of 2008."
Phase 1b Trial Design
The Phase 1b placebo-controlled study is anticipated to enroll
approximately 40 HCV patients. The study will assess the effect of multiple
doses of ITMN-191 given as a monotherapy on viral kinetics, viral
resistance, pharmacokinetics, safety and tolerability. Patients will be
administered ITMN-191 twice per day (BID) or three-times per day (TID) with
a meal for a period of 14 days. Three ascending dose cohorts of
treatment-naive chronic hepatitis C patients infected with HCV genotype 1
will be enrolled. In addition, a single cohort of treatment-experienced
|SOURCE InterMune, Inc.|
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