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Re: genisi post# 84302

Tuesday, 09/29/2009 8:52:08 PM

Tuesday, September 29, 2009 8:52:08 PM

Post# of 257262
Re: ACH-1625 Phase 1a results

You don't want to see clinically significant lab abnormalities or that the drug has a clinically significant effect on vital signs, QTc or ECG parameters. You can see AE in a phase 1a trial like in the case of ANA598, where 3 of 24 subjects dosed with ANA598 discontinued therapy due to grade 2 rash in the a healthy volunteer study (it was a 14 day study though).

According to the PR, there were "no clinically significant changes in vital signs, ECGs, or laboratory evaluations." So, again, I think this is a case of "so far, so good" with the caveat that this study just went out to 5 days and that there's still a long way to go in the clinic.

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