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Re: ghmm post# 41892

Thursday, 03/01/2007 5:25:59 PM

Thursday, March 01, 2007 5:25:59 PM

Post# of 257266
At the Susquehanna SIGnificant Investment Options in Healthcare conference Steven Porter was asked during the panel directly about Cardio Tox and the BI compound similarities. He stated the differences between the two (which InterMune has stated before) but He also stated that BI ran into cardio tox during 28 day Primate studies and went on to say that InterMune had done 28 day studies in Primates and did not see anything of concern. To my knoweldge this is the first time the company has given out this much detail.

Dr. Porter was also asked about combining 191 with Roche's Polymerases Inhibitor. He didn't give a specific answer but two things of note:
1-He said during the FDA Panel meeting they encouraged trying out combinations earlier then might be ordinarily. I wonder if some sort of accelerated approval path would be possible?
[EDIT: Saw this poster at EASL
ADDITIVE TO SYNERGISTIC ANTIVIRAL EFFECTS OF AN NS3/4A PROTEASE INHIBITOR (ITMN-191) AND AN NS5B RNA-DEPENDENT RNA POLYMERASE INHIBITOR (R1479) IN AN HCV REPLICON SYSTEM
S.D. Seiwert 1, H. Tan 1, L.M. Blatt 1
1 InterMune, Inc., Brisbane, CA, USA]
2-Given that InterMune has publicly stated they have a preclinical HCV target (outside of the Protease Roche collaboration) there is a decent chance InterMune has their own preclinical Polymerase. I guess a Helix Inhibitor is a descent possibility as well. Don't know if this would complicate combining 191 with Roche's Polymerase

On Pirfenidone InterMune said Q4 enrollment was ahead of schedule but continued with their Q4 Enrollment Goal. I still think it gets done early. I think I read that lung biopsy is required so this may be part of the reason its not quite as fast as I had thought/hoped.

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