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InterMune Reports First Quarter 2009 Financial Results and Business Highlights
Date:4/30/2009

) in late April, InterMune, Roche and Pharmasset, Inc. reported top-line results from the novel Phase 1 INFORM-1 clinical trial evaluating ITMN-191 in combination with nucleoside polymerase inhibitor R7128 but no interferon or ribavirin in patients with HCV infection. Data from the first four dosage cohorts of the study were as follows:
  • The combination resulted in sustained viral load reductions over the dosing period in all cohorts. Seventy percent (70%) of patients in the last two dosage cohorts had levels of virus in their blood below the limit of quantification by the diagnostic assay at day 14, and 33% of these patients had no detectable virus in their blood at day 14.
  • Patients receiving the combination of ITMN-191 and R7128 for 14 days experienced a median reduction in viral levels of -4.8 to -5.2 Log10 IU/mL in the last two cohorts tested.
  • In the early low-dose groups, after only three days of dosing, the mean reduction in viral load levels was 0.6 log10 greater with combination treatment (-2.9) compared to the performance of the individual compounds when given as monotherapy (-0.46 and -1.84 for R7128 and R7227, respectively).
  • The combination was well tolerated over 14 days, with no treatment-related serious adverse events (SAEs), dose reductions or discontinuations. Pharmacokinetic analysis confirmed that there were no drug-drug interactions between the compounds.

  • On April 21, InterMune reported that based on these promising early results, the INFORM-1 study had been expanded to explore the interferon-free regimen in treatment-experienced patients; both treatment failures and null-responder HCV patients and would include twice-daily dosing of ITMN-191 and significantly higher total daily doses (600mg and 900mg twice daily) than those explored in the first four patient cohorts of
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SOURCE InterMune, Inc.
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Related biology technology :

1. InterMune to Release First Quarter Financial Results on April 30
2. InterMune and Pharmasset to Discuss INFORM-1 Results From EASL Conference, April 25
3. InterMune to Present at Canaccord Adams Hepatitis C Conference
4. InterMune to Present at Citis 4th Annual Biotech Day
5. InterMune to Present Abstracts on HCV Protease Inhibitor ITMN-191 and HCV Development Program at the EASL Meeting
6. InterMune Reports Fourth Quarter and Full Year 2008 Financial Results and Business Highlights
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8. InterMune Announces Issuance of U.S. Patent for ITMN-191
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10. InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF
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