Sona Nanotech Inc (CSE:SONA, OTCQB:SNANF) CEO David Regan talked with Proactive about the company’s recent ethics committee approval for a pilot cancer study.
This approval represents the next step in Sona Nanotech's clinical development pathway, building on its current early feasibility study focused on late-stage melanoma patients.
The early study, which is currently underway, involves 10 patients with late-stage melanoma for whom other treatments have failed. Results from this group are expected within the current quarter.
Proactive: All right, welcome back inside our Proactive newsroom. And joining me now is David Regan. He is the CEO of Sona Nanotech. And David, it's great to see you again. How are you?
David Regan: I'm doing great. Great to see you again too.
News out today regarding ethics approval for your targeted hyperthermia cancer trials. It's obviously another step along the process that we've talked about in the past. Maybe just highlight this step and the importance of it.
Sure. And it might be a little bit confusing for some folks because we just announced another approval from an ethics committee, late last month or so, for our early feasibility study. But this is, in fact, for the next study to take place.
We really wanted to take this time right now — while we're conducting our first human trial and early feasibility study, which is really focused on understanding how a medical device functions in the real world of a clinic, in the hands of a third-party physician — to really hit the ground running when that's done, to be able to move on to the next step, which is typically a pilot study.
In essence, what's happening right now, and then you mentioned what it will lead into. The pilot study is what this particular news release deals with. So that pilot study will consist of what?
So, the study we're in right now is very limited. Regulators always do this — they want to mitigate risks. The first study is with ten patients who have late-stage melanoma for whom nothing else has worked. We're working on those folks now and we'll have results this quarter.
But the next step will move to a pilot study, which is 30 to 40 patients. You've perhaps worked out some of the kinks with the operational aspects of the device, and then there's a real focus on a larger population to understand the safety — and of course, we're looking for efficacy too — in that study.
And as far as timing is concerned, you're hoping that you'll be able to get to that by the end of this year and potentially into early next year?
Yeah. The key requirement, though, is regulator approval. The first thing you've got to get is your ethics approval. Once that's in place, that gives you the right to go to the regulators and get permission. So it's a function of that. But our goal is to be able to roll from one study into the next. Ideally, late this year or early next year to go into that next study.
All right. Well, congratulations on this first step. I know there's a lot in the process, and I appreciate you updating the market on where things are at.
Thanks. We're really pleased to be moving this quickly and getting geared up for the next study already at this stage.
Quotes have been lightly edited for clarity and style