I think those two studies, which should be finished by the end of this year, which will lead into a randomized trial in low-grade endometrioid endometrial cancer and that’s our goal.
Ahu Demir: Thank you, Steve. And the follow-up question would be in the solid tumor narazaciclib trial, are there any indications that’s dominating the enrollment, any particular indications will be more data on?
Dr. Steve Fruchtman: I didn’t catch that. You were asking about the monotherapy trial. What type of cancers are being put on to that? Was that your question or could you repeat it?
Ahu Demir: Yes. I mean — that is correct. In solid tumor narazaciclib trial, what indications are you enrolling and also any of the indications that you see more numbers of patients enrolling in the trial that we will see more data from those indications?
Dr. Steve Fruchtman: So the monotherapy trial is open to all end-stage cancers and is very variable. There’s no one type of cancer that dominates. It’s the typical end-stage patients that could include lung cancer, prostate cancer, bladder cancer, ovarian cancer. So it’s very diffuse and there’s no single indication that dominates. So I don’t think other than safety, Ahu, I don’t anticipate and we don’t expect to have any efficacy signals. The patients are very diverse regarding their indications and their cancers. The goal like most Phase I studies is just to establish a recommended Phase II dose and I think the endometrial cancer study, it’s up and running at the same time to combine recommended Phase II dose of monotherapy of narazaciclib with letrozole as the kind of the safety of the combination, which I already said, we anticipate it will be completely safe, just like it is with the competing CDK and the approved CDK4/6 inhibitors and we don’t anticipate any toxicity issues on letrozole is going to be added to the recommended Phase II dose generated from the monotherapy trial.
Ahu Demir: Thank you, Steve. Very helpful.
Operator: Our next question comes from Joe from H.C. Wainwright.
Unidentified Analyst: This is Surendar [ph] on for Joe. Thanks for taking our questions. I have two questions. The first question for narazaciclib, are we expecting any initial efficacy data in the readouts anticipated in 4Q?
Dr. Steve Fruchtman: So I will take that one. So the CDK4/6 inhibitors and that’s a great question, by the way. These are very important questions. So the investment community and the analyst who probably already understand how these drugs work. These are not cytotoxic drugs. These class of drugs prevent tumor proliferation. And if you look at the approvals for the three health authority approved CDK4/6 inhibitors, they were all based on two endpoints. The first is progression-free survival and the second is overall survival. And the reason for that is because they are not cytotoxic, you do not see many responses. You may periodically see a response, but it’s probably in single digits. So the way these drugs work to improve patient’s lives by prolonging PFS and prolonging overall survival.
And thus, to really evaluate that intelligently, you need a control arm, but you could use historical controls by all means. We are really in a modern era. The way to do that is with the control arm to show improvement in either PFS or OS, and thus, once we established the recommended Phase II trial, the next hurdle will be to open a randomized trial in early 2024 in LGEEC and that is our plan and we remain on target for that plan.
Unidentified Analyst: Got it. Got it. And one more question for rigosertib in RDEB. I may have missed it, but if you could provide us an update on how many patients are still pending to be enrolled in the Phase II trial.
