Sona Nanotech Inc (CSE:SONA, OTCQB:SNANF) CEO David Regan talked with Proactive about the company’s first-in-human clinical trial using its THT therapy for late-stage melanoma patients.
Regan explained that Sona has dosed the first patient in Santiago, Chile, marking a significant step from preclinical work into clinical testing. The therapy, which is technically classified as a device rather than a drug, is designed to make tumors more visible to the immune system, potentially leading to tumor shrinkage and longer survival.
Proactive: Excited to share the news about another major milestone with the company. And I know we've seen a number of these over the last while, but this is really an important step in the work that you're doing.
David Regan: This is where the rubber hits the road, and the company could not be more thrilled for its THT therapy to be used in human patients for the first time. We're treating patients with late-stage melanoma, stage three and four. We've gone through every other possibility in terms of the best immunotherapies in the world, which have failed for them, failed to respond, and we are now attempting our treatment in a top-tier clinic in Santiago, Chile.
You've dosed the first patient, obviously that's the significant milestone. Remind everyone a little bit about what you're trying to learn from the data that you would get from this particular patient and others along the way.
Well, of course, our therapy is not a drug. It's a device technically. And so there's a different phasing, if you will, of the clinical trials. The first is typically an early feasibility study that has the recognition that you really need to be able to test a device with a limited number of patients to understand the safety and tolerability profile, as well as many of the, what they call human factors, some of the utilitarian aspects of how the device is used practically in the clinic. And of course, we’ll be looking for efficacy data as well.
How long are you looking at keeping an eye on these particular patients? As I mentioned, your first one is happening right now. So can you give us sort of a time frame and what that will lead to in the future?
Sure. I'll give you a little information on the protocol, which outlines that we have patients dosed on first day, day one, as well as on day seven. We then have a check-in with them on day 14, 21, and 28. So we get a full month of following those patients. They'll be longer-term follow-ups as well. But that's really what this study is about—a 28-day study of each patient. Now, of course, depending on our enrollment rate, those patients will be staggered off over the summer, and we plan and hope to be able to provide initial results by the end of the summer.
Can you put into perspective the importance of what you're doing, but also the importance for these patients? As you mentioned, this is really the end of the line for them to try and find some relief.
David Regan: Correct. That's it. And when we talk about the efficacy and what we hope to achieve from the perspective of helping those patients, what's really going on is we're trying to get the tumor to be recognized, to be visible to the immune system so that the immune system can engage and help to eliminate the cancer. That's what its prospects are. So for those patients, longer life and the potential for tumor shrinkage is what we hope to achieve. From a company perspective, of course, this is a major milestone because we've shifted from being a preclinical company and graduated into being a clinical company for the first time.
Quotes have been lightly edited for style and clarity