COORDINATOR: And your next question will come from the line of Ren Benjamin of Rodman & Renshaw. Please proceed.
Q Hi. Thanks for taking the question. A, a couple of questions. One is, we've seen - at least in preclinical results - I believe some very interesting and substantial synergy with the GRN L compound. Can you give us some ideas as to how this, this may advance in the clinic regarding combination studies – in combination with chemotherapies. Will we, will we wait til the phase 1 mono therapy studies are done before initiating the combo studies or, or is there a chance that that might get initiated in the near term?
DR. OKARMA: Thanks, Ren. We will certainly complete our single agent studies before we entertain combination studies. And the reason for that is that we'd like to do combination studies based not only on empirical results where we actually combine 163L with other compounds and you're right, we've shown Taxol, doxorubicin, Velcade synergies observationally in vitro, but the real hook here is–appears to be that 163L is active broadly against cancer stem cells and as you know the recurrence of cancer is directly linked to the resistance of the cancer stem cell to sensitivity to virtually all of the currently used chemotherapy drugs. So if we can confirm that 163L, in our clinical trial, is active against the CLL stem cell, then that drives additional strategies about how to combine the drug with other agents whose activity is mostly directed toward the bulk tumor. Those are currently being thought about, but we have no immediate plans to launch them until we're a little farther along with our current Phase I/II program.
Q Okay. Can you give us a little feel maybe for how the Phase I/II programs are progressing, you know, clearly you, you want to present some data at the, at the end of the year at EORTC and ASH – could you give us an idea as to what sort of preliminary data we, we might see?
DR. OKARMA: No. We're not going to get ahead of our investigators on that, Ren, so we've agreed to be mum about the data until the actual presentations. Sorry.
Q Okay. Fair enough. Let me switch, switch gears here and go to GRNVAC1. What, what's happening there? What milestones can we expect from that program?
DR. OKARMA: Right. Well, the, the application here for our own IND is what's occurring. The steps first are to submit to the *RAC - that has happened. Once the RAC buys off of the application, then we file with the agency, and that is on track to happen very soon. So we would hope to actually begin enrolling subjects by end of the year under our own IND. We have not yet announced the actual tumor type; I can tell you that it is within the hematologic malignancy arena and the reason for that is the trial is designed to demonstrate a direct impact on tumor progression, which, as you know, has really not been described by anyone in the cancer vaccine space before and that is very difficult to do in prostate cancer because it's hard to get objective measures of tumor progression. So that's as much as I can tell you now, and when we're actually enrolling, we'll announce it.
Q All right. Thank, thank you very much.
DR. OKARMA: Welcome.
[*RAC: The NIH established the Recombinant DNA Advisory Committee (RAC) on October 7, 1974 in response to public concerns regarding the safety of manipulating genetic material through the use of recombinant DNA techniques.]
COORDINATOR: As a reminder, ladies and gentlemen, that's star 1 on your touch tone telephone for any questions. Your next question is from the line of Bernard Pinkus. Please proceed.
Q Hello. Yes. I have a question.
MR. GREENWOOD: Go ahead, sir.
Q Yes. I've been a stockholder for a number of years now. In order to make it easier to follow the drugs that you have, the different compounds like the GRN163L and the other one – at what point in the cycle do these drugs actually become names instead of numbers and letters so investors can follow it easier?
DR. OKARMA: Well, the general rule is that you don't apply names until the compounds are ready for commercialization, so that'll be a little bit downstream, so I think we just have to bear with the nomenclature. It is confusing, particularly on the stem cell side where a lot of the letters are actually close together. I appreciate the confusion. Thanks for the point.
Q Thank you. Okay. Bye. |
