There is a pathway for a single trial with single-arm therapy through accelerated approval with subsequent confirmatory trial through the accelerated approval process. We would propose that. A single-arm trial would take about 100 patients. If we’re required to do a randomized trial, it would be about 300.
Walter Klemp: Paul, let me add on to that. You mean elderly and unfit first-line, correct?
Paul Waymack: Yes, for our first-line therapy in elderly and unfit patients, we would do a single-arm study, which is not that far off from what Venexa [Ph] was doing, and get approval on a single-arm study, accelerated approval. And then, again, if you do accelerated approval, you need a confirmatory trial, more of a traditional randomized trial where we would go broader indication, randomized versus an active control arm.
Jonathan Aschoff: Okay. Just to make it clear that it’s somewhere in the lower triple digits of patients per trial is helpful. Thanks. Can you lastly answer, what kind of progress have you made in finding funding or getting an investigative sponsored trial going with the other two products, 1066 and 1112?
Walter Klemp: So, let me start there, but, John, you may have some nuance that you want to add to this. One of the – probably one of the most prolific areas of outside funding has been with our STAT-3 inhibitor, 1066. And just a quick recap, MD Anderson sponsored a trial there, then Emory University in pediatric brain tumors, and then the investigator that was at MD Anderson moved to Northwestern University. And we’ve been in ongoing discussions with that investigator. It’s very likely that that investigator will come through with another externally funded trial for brain tumors in 1066. And we know that the folks at Emory are awaiting some additional data to come from the adult progress before they kick off. They’ve already indicated they want to kick off another pediatric brain tumor trial.
So they’re symbiotic there. They’re comparing information. There’s essentially a consortium of folks across the U.S. that have now recognized there’s clearly some potential for activity of 1066 in brain tumors, and especially when it comes to pediatrics. And then finally, we continue to grind away on an IV formulation for 1066. And on the investigators I’ve just described have all made it clear the instant that we have an IV formulation, they intend to switch to that because we all recognize that the PK characteristics are probably going to be better with an IV delivery of that drug. On the 1122 side, we continue to right now just be moving at what I call grant speed on the basis of U.S. government grant funding of virology research as it relates to 1122.
So that’s our primary focus there. But let’s face it, that stuff is highly speculative and it’s slow moving. So I would say that the slowest program we have in the portfolio right now is 1122.
Paul Waymack: All right. Thanks. And then I would add to that. I would add that the Northwestern trial is already listed on clinicaltrials.gov. It’s 1066 in combination with radiation against GBM.
Jonathan Aschoff: Okay. Thank you. And the queue [Ph] will come out later today?
Paul Waymack: The queue should have already been filed.
Jonathan Aschoff: Okay. Thank you, guys.
Paul Waymack: Thanks, Jonathan.
Operator: Thank you. Our next questions come from the line of Jason McCarthy with Maxim Group. Please proceed with your questions.
Jason McCarthy: Hi, guys. Thanks for taking the questions. In the STS data, with the median PFS, it looks like its 3.4 months for patients who are less than 330 mg per meter squared. You mentioned that the overall survival median so far has reached 11 months in 15 patients from Phase 1B. What was the trabectadine OS before it was approved? I know it didn’t move the needle much on OS, but it did. It must have had an OS. That’s the first. Yes. Okay.
Walter Klemp: I’ll jump in there because I looked at the paper they’re referencing. They really don’t go into PFS, I mean, OS data. They really focus on PFS data. That’s why we’re so excited about the median OS that we’re receiving.
Jason McCarthy: Okay. And mechanistically, for Annamycin, what do you think the differences are where you’re having to go 330 mg per meter squared or less in the STS trial, but you’re going higher in the AML trial?
Walter Klemp: Let me start that off and, Paul, fill in wherever you think I maybe haven’t covered it adequately. I think there are two dynamics here at work. One of them is the specter of thrombocytopenia in patients. So we know that even though we can technically cross the hurdle of not reaching a DLT and keep, in fact, we never did establish an MTD in that trial, but as we bumped up against 390, the handwriting was on the wall that the thrombocytopenia issue with patients was going to become a barrier to ongoing treatment. And so we felt like, okay, we’re seeing similar activity at lower dose levels, so let’s not push the envelope here. Let’s work in the center of the therapeutic window, if you will. More specifically to your, because I understand your question, why do we think that we might not get any more benefit out of higher dosing because classically speaking, higher is better with an anthracycline?
