So, we have done measurements of the amount of blood pumped out each time. it’s done by you can do it with an echocardiogram. And we have obtained these. We have sent these to outside experts for them, outside expert cardiologists to review and to give us the number. And what they have found in every patient study to-date is that the ejection fraction before the first dose of anthracycline remains the same throughout the study. Within reason, it may go from 65% to 66%, or 50% to 49%. But it never changes significantly. Overall, the means are the same. So, we have diligently sought any evidence of cardiac toxicity. In all of our patients and all of our canceled trials, we have not found a single one on a patient to-date. That doesn’t mean that at some point in the future, when the number of patients is goes from 50 to 250, or whatever, we won’t see an occasional one.
But this major cardiac toxicity problem which limits the dosing of anthracyclines, we have not seen any evidence of it to-date.
John Paul Waymack: And Jonathan, I would just add, one of the things I think that’s important about that paper is, I think you know this well, but there are a couple €“ there are a few other anthracycline projects out there that try to make claims as it regards reduced cardiotoxicity. And what we found is sometimes we get in conversations with people, that there is some confusion that they think there are other non-cardiotoxic anthracyclines out there. I think this paper sets the record straight. To-date, to our knowledge and to the knowledge of those authors, there is no other drug that comes even close to Annamycin in terms of its level of non-cardiotoxicity. So, I like the fact that this has now been set forth in black and white and we can reference it to dispel any myths that they would be non-cardiotoxic competitors out there.
Jonathan Aschoff: Yes. It sounds like a very useful manuscript. Thank you, guys.
Walter Klemp: Thanks Jonathan.
Operator: Thank you, Next question is coming from Jeff Jones from Oppenheimer. Your line is now live.
Jeff Jones: Good morning guys and thanks for taking the question.
Walter Klemp: Hi Jeff.
Jeff Jones: Hi guys. Couple of questions to build up what Jonathan was talking about, on the FTS study, what is €“ do you have sort of a hurdle rate for what you believe is a clinically meaningful impact on progression free survival? That would then trigger you to move into pivotal study?
Walter Klemp: Yes. That’s obviously another Paul question. Please take it away, Paul.
John Paul Waymack: Yes. It’s always difficult to define exactly what will lead you to go forward. I won’t quote Stewart’s definition of another thing, but it’s going to be a combination of how good is the progression-free survival, the average and how narrow are the standard deviations. I would think that if we are able to double what would be expected with placebo, which is six weeks, that’s a very strong indication to go forward, because again, those six-week progression-free survival and placebo arms, those were second line therapy, and we are nowhere near second line. We are far beyond that. So, if we can be ballpark doubling with the placebo got, then I think it is time to go forward aggressively.
Jeff Jones: Okay. And just to clarify, when you are saying placebo that it’s not actually placebo, but standard of care, is that correct?
Walter Klemp: No, there were actually other studies with standard of care that didn’t work, which were six weeks. These were studies from a while back. But if €“ there are some review articles out there. And I don’t want to cite one after over another. But if you do searches for review articles from some of my friends, you see frequently six weeks for either placebo or for certain drugs, when that’s telling you that those drugs don’t work at all. So, I think we can confidently say, if you have soft tissue sarcoma, you have failed primary therapy, and nothing is done in six weeks. Radiologically, there will be documentation you have progressed.
