Question-and-Answer Session
(Operator's Instructions) We'll go first to Rachel McMinn with Bank of America-Merrill Lynch.
Rachel McMinn - Bank of America-Merrill Lynch
Thank you much for taking the question. You've mentioned that data from combination studies where telaprevir and 222 could be available by mid-2010. I know you're not prepared to talk about specifics of the trial design there, but what kind of data are you talking about? Is this RVR data?
And then secondly, are regulators requiring any type of combination in animal tox data prior to starting these studies, and if so, do you have that data?
Ian F. Smith
Thanks, Rachel. It sounds like more of a disclosure so I'll let Peter give you some background of how we're thinking of the trial and the second question of the tox data. But by mid-2010, given the trial that we're currently contemplating and discussing with the regulatory authorities, we should have interim data that will give us an understanding of the biokinetics and also when we say biokinetics it's not just the log drops, but also whether we have viral breakthrough over a duration and over duration for the study.
We need to understand what kind of duration we can conduct the study at. As we think about the study it will be all different forms of combination with telaprevir and 222 and it'll include with and without ribavirin and we hope to have data mid-2010 specifically in the viral kinetics and breakthrough and initial safety profile.
Peter Mueller:
So in terms of the tox studies and the regulatory requirements around those, what's important to understand is we have already a complete safety package for telaprevir and there is 2,500 patients included. I think we should, first of all, mention that. And secondly, we have completed 12 week nonclinical tox studies with VX-222 that would allow us to go at least go in a three-month regimen.
Now, in terms of requirements given the least movement, what is required for the regulatory agencies is that you have at least for each of your experimental drugs which telaprevir is not really see as that any longer, but in general a 12 week type of tox study and then you can move forward. What I step away from and make it a little earlier in these early, more experimental phases is that you don’t have to provide a combination tox study with both compounds in animals provided up front. So we are in discussions with regulatory agencies as we speak and we will be keep you updated as to when we get feedback and can talk about it.
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