Our product that we think is the next wave of innovation for Portola. It is very, very exciting because we are starting to see clinical activity in patients that are very sick and have real end-stage cancer and some of this hematologic cancer. Two signaling pathways. We know that there are tumor progression cells and tumors that progressso these pathways of B-cell or cytokines are really the basis for some of these hard-to-treat hematologic cancers CLL, DLBCL, folliculars. This drug is unique. It is the only drug. It is in a class we believe by itself that targets both in a single pill, targets both the B-cell side of signaling pathway and also the JAK-STAT or cytokine pathway.
We are starting to understand the molecular basis by which some of these patients are either resistant or relapsed. This is a data point we have been showing for a while. We are understanding the resistant mutation associated with patients who relapsed on ibrutinib, at least in vitro. We have shown that if you take those cells that relapsed and progress, that if you treat them with cerdulatinib that you can stop the progression.
Perhaps, this is some of what we are seeing in our Phase 1 trial. We do not know. We are starting to get the genetic footprint of somebody’s patients. We have now escalated – how many doses John?
John Curnutte, Executive Vice President of Research and Development, Portola Pharmaceuticals, Inc.
Seven.
William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc
Were up to seven and we have gone past this. What unique about this drug is that the targeting is highly specific. We are seeing it at a high level, both Sykand JAK and we are still escalating because the tolerability of this drug thus far has been somewhat remarkable.We have not MTD yet. We expect to soon, but in the meantime, we think we are comfortable listing some of the cohorts for expansion that we are going to move forward.
What do we see?We showed that we had a response at ASH. Now, we are starting to see a number of responses as we dose-escalate. The good thing is we are still seeing the tolerability that we saw at the lower doses with this drug. I mentioned the expansions. Where we do we go look at? We look at CLL, certainly follicular lymphoma. We are looking specifically now at DDK and PI3-kinase failures. We have seen activity in this study now in some of these patients. Certainly, we want to continue because of the cytokine activity of this drug. We think DLBCL is still a target of us and we just like to maybe understand genetically where we want to go. We are going probably look at combinations because of the tolerability of this drug and unique… both the tolerability and the unique mechanism probably give us a fabulous chance to assess this drug in combination with other compound.
This is the year and two years ahead. Again, we are talking BLA submission, potential product launches, topline data, another NDA. You are looking at 16 submissions and as this drug progresses as well, we are going to try to find a path to accelerate its approval to the market as well.
It is a pretty exciting time. It is really just about execution for us. Thus far, we have been pretty good and we hope to do it for the next few years as well. Mardi, you can answer questions on cash, 437 million in cash equivalent in investments as of 10/03/14. That is the Q3 performance. Yes, the Q3. We are doing Q4 March 10. Questions?
