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Re: DewDiligence post# 77776

Saturday, 05/16/2009 1:43:51 PM

Saturday, May 16, 2009 1:43:51 PM

Post# of 257266
Re: VRUS (R7128 pre-clinical kidney tox)

As I've mentioned before, I'm taking a much closer look at VRUS and may establish a position (actually may swap ACHN for VRUS entirely now) once the initial Phase 2b safety data for R7128 is out on the first 100 patients in 2H 09. I think this event will reduce, though perhaps not yet eliminate, some of the kidney tox concerns that were evident in pre-clinical tox studies in monkeys.

I'm just curious, though, do we know what the dose was that showed kidney tox in monkeys? I know the dose was much higher than the dose in humans but am curious if we know the exact number. And how long did it take before the tox appeared? I believe the interim Phase 2b safety look will be after 12 weeks.

Regardless, I assume pretty much any drug is going to show toxicity if you dose it high enough and for an extended timeframe so perhaps any fears of kidney tox from R7128 treatment are overblown. This may be particulary true if the kidney tox in monkeys occurred at both a much higher dose and for a much longer duration of treatment than that being tested in humans.

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