Your first question will come from the line of Mark Monane of Needham; please proceed.
Q Good morning and thanks for taking my question. I have a question for, for Tom on 163L milestones for the second half. Could you please review that with us. And then secondly, we note that 163L has a unique mechanism of action binding to telomerase. How much telomerase inhibition do you need to have in order to have a clinical effect and do you believe this is going to vary across the different types of tumors studied.
DR. OKARMA: Thanks, Mark. Good questions. The main activity for 163L in the second half of the year is to ramp up both sites and patient recruitment activities in our two clinical programs. We are hoping to present at both EORTC and ASH our – the one abstract is in, the second goes in this week – obviously the abstracts have to be accepted. We would expect to have several cohorts to report on by the end of the year if these abstracts are accepted. We continue to tweak the protocol to ease patient enrollment and to recruit additional sites, and there may be an additional site coming on board before end of the year. So we're trying to really enlarge, deepen and broaden the clinical trial group that we're working with to demonstrate safety and activity of the compound.
Your second question is a good one and quite frankly is one of the objectives of the CLL trial – to determine elegantly the correlation between blood level of the drug, telomerase inhibition in the tumor cell in the blood – in the CLL cell – and correlate those PK/PD parameters with a tumor response. The reality though is from all of our pre IND studies is that between 70 and 80% inhibition is more than enough to drive tumor cells into apoptosis and I can't say that we've really seen anything systematic according to tumor type that alters that nomegram. Obviously, the proof is in the pudding in people. So we would expect to achieve 70 to 75% telomerase inhibition at relatively low cohort doses. So, stay tuned for the answer to that question [] Thanks, Mark.
Q Thank you. Thanks for that information.
COORDINATOR: And your next question will come from the line of Joel Sendek of Lazard Capital Markets.
Q Thanks. I have two questions. First, on the financial side. Did you say the net burn would be $30 million?
MR. GREENWOOD: Yes, Joel.
Q Did you, do you have any guidance on gross burn?
MR. GREENWOOD: That'll be about, just under 40, about $39 million.
Q Okay. And then on the IP front, I've just been thinking, you know, for the bigger picture perspective on the European versus US intellectual property position, could you just comment a bit on, you know, how important the European patents are - especially in the context of, you know, if there are fewer restrictions on the development of embryonic stem cells ex US, would, would that be, would that make the IP portfolio ex US even more important? Thanks.
DR. OKARMA: Well, as you know, the European situation in terms of even granting intellectual property protection for undifferentiated embryonic stem cells is up in the air and is currently being reviewed at the highest level. I've been invited to contribute to a political piece of work on embryonic stem cells which is now finished and actually was used to try to drive the Framework Funding in Europe for covering embryonic stem cell research. And you may have read last week that that was successful, the group having overcome some objections by some small Catholic countries. The reason I mention that in the context of the answer to your question is that we sense a groundswell in Europe in support of embryonic stem cell research as there is in the United States and the difference though is that Europe, Europe is beginning to actually throw government money after researchers working on this technology. We think that will translate into a dehiscence of the blockage in getting these stem cell patents to issue. There may need to be altered prosecution strategies, again depending on what the opposite–what the Appeals Division decides on the public morality issue which has thus far blocked the issuance of the Wisconsin patent. So how it shakes out, Joel, it's a little murky to predict, but we hope that the funding decision is a sign that the European governments collectively recognize the power of the platform and obviously the need to protect it if products are to be commercialized in Europe based on the platform.
Q Okay. But given the lack of final decision at this point, you would argue that your US patent position is, is much more clearcut?
DR. OKARMA: Oh, absolutely.
Q Okay. All right. Great. Thanks.
DR. OKARMA: You're welcome. |
