Joseph Pantginis: So this might be jumping the gun a bit here. Obviously, you need to talk to the FDA first with regard to rigosertib’s potential in RDEB. But with that said, do you have, I guess, any sort of broad strokes to take right now, both internally and maybe from any external sort of regulatory consultants that might give you an early wish list that you can share with us regarding a potential design?
Steven Fruchtman: Well, the wish list, Joe, won’t require a design. The results that Dr. Gelder shared with us, the patients and the experts who see these patients are extraordinary. They have failed everything else, and as we mentioned, we have complete cutaneous responses. This is an ultra rare disease, and we have already demonstrated complete responses where nothing else works. Our regulatory consultants are the one saying, we should go to the FDA now and ask the question, what will it take to get rigosertib approved in squamous cell complicating RDEB. We don’t know if the current 2 patients are enough. Will they want an additional 2 patients? We really don’t know what the end is going to be. And as Mark said, hopefully, before we meet with the FDA, maybe we’ll have 1 or 2 additional patients.
The incidents of this disease in the U.S. is 100 — about 100 RDEB patients a year. Maybe 50 live long enough to develop squamous cell carcinoma, but it’s very hard to identify these patients as you know. In addition, the other wish is because this is a pediatric disease, the RDEB expresses itself in the pediatric age population. We are told that periodically a child with squamous cell, mostly the young adults who developed the squamous cells. The 2 patients that we treated are, in fact, young adults. This will be presented in greater detail at the International Dermatology Meeting in Tokyo, Japan that’s coming up, but we are continuing to look for additional patients. And if we’re very lucky — but it may not be necessary to find a pediatric, it’s hard to say lucky to find a cancer in a child.
But if there is a child out there anywhere in the globe that we become aware of, we, of course, would be very interested in treating that child with rigosertib and discussing the possibility of a pediatric voucher for squamous cell complicating RDEB. So those are our wishlist to get rigosertib approved in this indication and to discuss the possibility of a pediatric voucher with the FDA.
Operator: Our next question comes from Robert LeBoyer from NOBLE Capital Markets.
Robert LeBoyer: I had a question that I think was partially answered earlier. But if you’re going into a sixth cohort for narazaciclib, could you give any kind of timeframes as to when the sixth might be completed or the seventh or even an eighth, if you go that far? And when you might start the Phase II?
Steven Fruchtman: Mark?
Mark Gelder: So it’s impossible to say when a cohort is going to get completed. You have a 3 plus 3 design, and it depends on if you get a DLT, it depends on how many screen fails you have, et cetera, et cetera. So typically, it takes — if you can — if you don’t have any significant problems, don’t have a lot of screen failures, et cetera, you can complete a cohort of 3 in 2 to 3 months. But if you have a DLT and then have to expand it out to 6 or if you start having several screen failures, et cetera, it can take 4, 5, 6 months to complete a single cohort. So it’s really impossible to say. Our fifth cohort, as you’re all well aware, took several months to complete because we had several screen failures, et cetera, but that’s just the nature of clinical research.
