Question-and-Answer Session
Operator
(Operator instructions) Your first question comes from the line of Mark Monane from Needham & Company. Please proceed.
Mark Monane – Needham & Company
Thank you, good morning, and thank you for the comprehensive review.
Brian Schwartz
Good morning.
Mark Monane – Needham & Company
Glenn [ph] is on the line as well and has a question. Mine has to do with the sarcoma trial. Can you help us understand a little bit about the a priori [ph] outcomes that you have in terms of how to evaluate the data before it comes out? And then, help us think about how progressions-free survival response rate might inform a survival trial going forward?
Brian Schwartz
Mark, this is Brian Schwartz here. In terms of the current trial, the way that it's set up, we will be evaluating closely both response rate as well as the progression-free survival in the three subgroups we're evaluating in the MiT trial. Based on that information, we have met with a bunch of experts who've advised us what criteria we must probably need to see in the Phase III trial. And as you mentioned correctly, this will incorporate both a response rate driven endpoint and potentially a progression-free survival endpoint as well.
As you are aware, a number of trial designs may offer you the opportunity to get both, such as the randomized discontinuation design and other ideas that we would have to vet [ph] with the appropriate authorities before deciding on a final trial design for our Phase III program. So just in a nutshell, we currently evaluating the data, as we complete the trial, will be going to the appropriate authorities to vet the design and the exact end points we'll have to achieve.
I think the last point to mention is that the two sarcomas that we're looking at are relatively rare. So that the number of patients available would have to be accounted for in the trial design itself in order to get the Phase III data in a reasonable timeframe. So taking all of those things together, we'll vet this and make sure that the Phase III design is acceptable for approval.
Mark Monane – Needham & Company
That was fair. And Glenn has a question as well.
Glenn – Needham & Company
Yes. Congratulations on initiation of the Phase I trial in HCC. I had a question on – a couple questions, one on patient selection cirrhotic is – there is something special about that population? And second, for the end of the phase I trial how does the company feels that ARQ 197 will sort of perform in the spectrum of multi-targeted kinases like (inaudible) or sorafenib being that it's not a promiscuous ATP kinase.
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