Replies to post #60863 on Biotech Values

[tony111]

Dew,

I have a naive question to ask. For an open label sutdy, does the company get to know the partial data as soon as the first patient done treatment or they only get complete data when the study is complete.

[DewDiligence]

InterMune Provides Additional Information on ITMN-191 Phase-1b Results

[They now give the median log reduction in viral load for each cohort at the end of treatment as well as the previously disclosed mean log maximum reduction. This should quiet some of the critics on yesterday’s CC who wondered whether ITMN was hiding major viral breakthroughs by withholding the EoT data. We can now see that in the higher-dose cohorts that will presumably be the ones taken into the upcoming combination study, there are small viral rebounds but no undue concerns. (Thanks to ghmm, who caught the error in my original post on this PR).]

http://biz.yahoo.com/prnews/080402/aqw077.html

>>
Wednesday April 2, 8:00 am ET

BRISBANE, Calif., April 2, 2008 /PRNewswire-FirstCall/ -- Following its press release and conference call of April 1, 2008, InterMune, Inc. (Nasdaq: ITMN ) today provided additional information on its Phase 1b multiple-ascending-dose (MAD) study of ITMN-191 to facilitate comparison with previously published data describing other HCV protease inhibitors. The additional information pertains to the Day 14 median reductions in HCV RNA in this study (see table below).

Mean Maximum
Reduction Day 14 Median
Total HCV RNA HCV RNA Reduction
Cohort Dose Daily Log10 IU/mL Log10 IU/mL
Dose (mg) (%*) (%*)

1 100 mg q12h 200 1.6 0.7
(97.49%) (80.05%)
2 100 mg q8h 300 2.6 1.7
(99.75%) (98.01%)
3 200 mg q12h 400 3.4 3.1
(99.96%) (99.92%)
4 200 mg q8h 600 3.9 3.8
(99.99%) (99.98%)

*Calculated from log10 reductions shown in table.

[As previously reported:] One final cohort consisting of treatment-experienced patients dosed at 300mg every 12 hours will begin dosing next week.
<<