Medicus Pharma (NASDAQ:MDCX) CEO Raza Bokhari talked with Proactive about the company’s progress in its Phase 2 study targeting basal cell carcinoma — the most common form of skin cancer.
Bokhari shared that over 75% of the 90 patients in the proof-of-concept trial have been randomized, with full enrollment expected by the end of the year.
The study is investigating a novel, non-invasive treatment option. Bokhari confirmed that Medicus Pharma has requested a Type C meeting with the US Food and Drug Administration (FDA) to align on the design of the pivotal study.
Proactive: All right, welcome back inside our Proactive newsroom. And joining me now is Dr. Raza Bokhari. He is the CEO of Medicus Pharma. Dr. Bokhari, good to see you again. How are you?
Raza Bokhari: Thank you so much for having me back on your program.
A couple of things to talk to you about. I know you put out your financial numbers — we'll talk about that in just a second. But first, let’s begin with the work you’re doing. You've had some conversations with the FDA, and you're ready to take the next step with them. Maybe explain where we're at here.
Appreciate that very much. As your audience is familiar, we have a Phase 2 proof-of-concept study for 90 patients. It’s designed to bring to market a novel, noninvasive treatment alternative for the most common cancer — basal cell carcinoma of the skin. We’re now at an inflection point. We've reached out to the FDA to request a Type C meeting to get more clarity and further alignment on how the pivotal trial will look. We've already randomized more than 75% of the 90 patients.
So we know that our proof-of-concept study should have all patients randomized before the end of this year. We're now getting ready to embark on what the pivotal study should look like. We also wanted to confirm with the FDA whether we qualify for fast track designation. We're excited that the FDA agreed to take our queries and confirmed that they will provide further guidance before the end of this quarter.
And I guess that’s the key here — that the FDA is working alongside you to make sure things are on the right track. That allows you to fast track and avoid problems before they happen.
That’s a good way to look at it. The FDA is not required to accept all Type C meeting requests. But they chose to accept ours. We believe that’s a very positive sign — that the FDA is engaged and responsive to the clarity we need. That helps us use shareholder capital more efficiently and effectively as we advance our clinical studies. We’re one step closer to bringing to market a noninvasive treatment alternative for a cancer that represents a $15 billion market. This is a huge opportunity for us.
You mentioned that more than 75% of the 90 patients have been randomized. So you're well on track?
We are very well on track. We’re randomizing patients across nine sites in the United States and setting up two sites in Europe. However, patient recruitment is proceeding so quickly that we may not end up enrolling patients at the UK sites in time. But the important thing is completing randomization before year-end — and we’re ahead of schedule.
This all takes capital, and your financials show you’re in a good place. You’re happy with where the company stands?
The fundamentals of the company couldn’t be stronger. Our cash balance was reported at $11.30 million as of June 30th. Our clinical development program is progressing well. We’re also finalizing the acquisition of UK-based Aim, which we expect to close by the end of the month. Additionally, we’re exploring co-developing thermostable vaccines with Helix Nano. So yes, in terms of cash and project execution, we’re in a very good place.
Quotes have been lightly edited for clarity and style