tolerability results of ITMN-191 were excellent.
-- That the trial had achieved its principal goals for viral kinetic
performance, safety and tolerability to advance the program into a
triple combination study with Pegasys(R) and ribavirin.
-- It expected to complete enrollment of the third dose cohort in the
MAD study in January 2008. InterMune announced today that
enrollment of that cohort was completed in late January and that
data from the third cohort are not yet available to the company.
-- InterMune expects to begin a 14-day triple combination study of
ITMN-191 with Pegasys(R) and ribavirin in the second quarter of
Guidance for 2008 Operating Expenses
InterMune today provided its forward-looking guidance with respect to operating expenses in 2008.
For the year ending December 31, 2008, R&D expense is anticipated to be similar to 2007 in a range of approximately $100 to $110 million, net of development cost reimbursements under the Roche collaboration. G&A expense is anticipated to be in a range of approximately $25 to $30 million.
Key Development Program Milestones
InterMune today noted the upcoming milestones with respect to its key
CAPACITY Program in IPF:
-- InterMune expects to announce top-line results of its Phase 3 CAPACITY
program in IPF in January of 2009.
ITMN-191 Program in HCV:
-- In conjunction with its partner, Roche, InterMune has decided to
complete a fourth cohort of the Phase 1b multiple-ascending-dose (MAD)
study to further inform the planned 14-day triple therapy study and
potential direct anti-viral combination studies in the future.
Consequently, InterMune has decided to announce results from the first
four cohorts of the Phase lb MAD study
|SOURCE InterMune, Inc.|
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