Boris Chertin: Thank you very much, and thank you for having me here.
Ashish Kamat: Of course. There's a lot of exciting things happening in bladder cancer, a lot of new drugs being developed. You actually have the position of taking a existing combination, Gem/Doce, and providing it in a way that is easy to deliver to the patients. And you're presenting data here at the AUA that talks about the nine-month data with the NDV-01. So, share with our audience a little bit what you presented, starting with the background. What exactly is this delivery mechanism? How does it work?
Boris Chertin: First of all, as you mentioned, the Gem/Doce, it's a very well-known combination for treatment to patient, especially patient with BCG refractory bladder cancer. Especially the fact today is the running study, the British studies, also compared the patient who is getting gemcitabine dose versus BCG. We initially wanted to consider the patient with BCG unresponsive patients. Since we don't have any very well-working combination of medical therapy, and we are not able to avoid, in the majority of those patients, a radical cystectomy, as we all know, the surgery which can bring out the huge ratio of the complications. And I would like to spare our patient of muscular invasive disease, and also to undergo radical cystectomy. We did know that Gem/Doce works very well with patients. And the initial papers published 55% of the success rate, in spite of the fact that it never been approved by the FDA as a treatment for the BCG refractory patients.
We thought that our technology, which will allow to create kind of gel deposit inside of the bladder, and we are able to provide patients sustained release against the Mendoza over the period of time, and we'll increase the variant effect. We'll actually able to overcome all of shortcomings of intravesical therapy. We'll be able to provide our patients much better treatment, decreasing at the same time the economical effect and the time to human effect. Because, as you know, they are not able to provide Gem/Doce in non-academical centers. As I know, in states, the majority of those patients are treated in the community centers and the community centers are not able to provide Gem/Doce intravesical therapy for those patients because we don't have the designated pharmacy are not able to keep those patients in outpatient facility for six hours. This is the reason it just draw us to develop this combination.
Ashish Kamat: Sure, sure. And that background is well-known, but tell us a little bit about actually how the delivery mechanism works.
Boris Chertin: This is the actual ready-to-use material. It consists of actually coming out as two syringes, one syringe with some gel, and the second syringe which contains Gem/Doce. Those are embedded on a combination of lipophilic polymers, which dissolved in DMSO. So, when you inject the gel and following the gel straight away, you install the Gem/Doce, it creates inside of the bladder kind of gel depot, which will able to constantly release the Gem/Doce over the period of time.
Ashish Kamat: Right. And, of course, there are several studies being planned, and ongoing, in the BCG responses space, intermediate risk bladder cancer. Share with us your poster, what you presented.
Boris Chertin: So, we initially wanted to treat our patient, the only BCG refractory patients, but since it's a pilot study and want to test our combination, our idea how this combination and our delivery system work on this patient, we substantially included the patient with naive patients, patients also patients with some insight that is standalone. So, actually, I was surprised that over the period of 12 months, we got a very good results. It's 95% of complete responses anytime, 75% complete response at 12 months. And if I extrapolate the BCG refractory patient from this group, BCG refractory patient showed actually 80% of complete response after that 12 months.
Ashish Kamat: So, in this group of patients, you had BCG refractory patients as well? And how did you define the BCG refractory patients?
Boris Chertin: We actually defined the BCG refractory patients as it was suggested by the European Guidance and American one. Those patients who at least received six or five installation of BCG, and also two or out of three maintenance dose and develop the high grade bladder carcinoma for all of that.
Ashish Kamat: Okay. So, you mean the BCG unresponsive patients?
Boris Chertin: Yes.
Ashish Kamat: Right, right, right. Because when we propose a definition to the FDA, it's the BCG unresponsive. Refractory is a little bit different. So, that's good. That's good. So, tell me again the patient makeup in the study. How many patients with T1, CIS?
Boris Chertin: I think our demographic data reflects the common population that people are treating in the community practice. We have half patients with TA, a little bit more than half patients with T1, and we have, out of 50 patients we are treated so far, we have approximately 10% of patients with carcinoma of the bladder.
Ashish Kamat: Okay. And then, talk to us a little bit about the adverse events.
Boris Chertin: Yeah, it's very interesting because adverse events, if you look at the data on the Gem/Dose, some of patients are developed liver toxicity. Some patients presented with drop of the hemoglobin level. Actually, the majority of our patients, we had adverse group one and two only. The majority that, as you expected from the intervenical therapy, we presented with dysuria and some burning during urination. The majority of those patients, the majority, all grade one effects just resolved by itself by 24, 48 hours. None of our patients, none, presented grade three and high side effects. So, that's from the safety point of view, our study showed the superiority, if you compare the BCG patients. Very interesting. What we did, we actually ask our patients who've been exposed BCG before. We ask about the quality of their life, how it was during the BCG therapy, and how did they feel with the NDVO 01, and all patients were responded with quality of life much more superior compared with the BCG period of their life.
Ashish Kamat: Yeah. And we've been using Gem/Doce now for almost 15, 20 years, and the patients do tend to tolerate a little bit better. We have used pre-medication in some of the patients. Have you had to do pre-medication?
Boris Chertin: We do. Actually, we prescribe sodium bicarbonate day before, just to alkalize the urine and to get much better side effect profile. But, usually don't use any painkillers, any hydration, which is good for our combination. You don't need to keep those patients in outpatient facility. The injection process, the installation process, it takes approximately five minutes. It can be done by the nurse and the patients go home. They don't need to stay there.
Ashish Kamat: Great. So, first of all, congratulations on the presentation and share with us a little bit about next steps. Where is this heading?
Boris Chertin: Yeah. Actually, the combination was developed by the Israeli startup company now with the RLMADA pharmaceutical. We take over the process of the launching of this combination in the wide clinical practice. So, we are going to pursue two objectives. One, to launch the multi-center study, here in North America and Canada. I think we are just have approximately 80 sites who are interested to take part of this study, and we would like to test this study in BCG refractory patients, and also to test as adjuvant therapy, following transurethral resection of the bladder tumor in the intermediate risk of patients. So, I think two of those two groups, it will be the main purpose of the next development NDVO in the clinical practice.
Ashish Kamat: Okay, great. Well, thank you so much for taking the time and sharing with us.
Boris Chertin: Okay. Thank you very much for having me here.