Medicus Pharma (NASDAQ:MDCX, TSX-V:MDCX) provided an update on its phase two clinical trial for a novel non-invasive treatment targeting basal-cell carcinoma.
CEO Raza Bokhari told Proactive that 25% of patient recruitment for the U.S.-based trial has been completed. The study, involving 60 participants across nine sites, began in summer 2024 and targets basal-cell carcinoma, the most common skin cancer with 5 million new cases annually in the U.S.
Bokhari highlighted the global burden of the disease, estimating up to 30 million new cases yearly worldwide. The company has announced plans to expand the study into the Asia Pacific region, where limited access to surgical options makes its patented microarray needle transdermal patch even more relevant.
Proactive: Some news you had recently, announcing that you’re now into your phase two study, and 25% of the targeted people involved in it have been chosen. That’s a pretty good milestone for you, isn’t it?
Raza Bokhari: We are delighted with the progress we’re making in our clinical development program. We initiated a phase two study this summer to advance our non-invasive treatment regimen for basal-cell carcinoma, the most common type of skin cancer, which sees five million new cases every year. The only current treatment is surgical intervention, costing $15 billion annually.
We’re working to offer a non-invasive, cost-effective, relatively painless, and aesthetically pleasing alternative, which could disrupt the market. Our phase two study involves 60 patients at nine sites across the U.S., and we’ve completed 25% of recruitment, which is substantial progress.
You’ve also announced that you’re expanding that study into the Asia Pacific region.
Indeed. Basal-cell carcinoma isn’t just a North American problem. Anywhere there’s sun exposure and fair-skinned populations, there’s a risk of this cancer. Globally, the incidence could be 25 to 30 million new cases annually, far exceeding the U.S. numbers.
Unlike the U.S., where surgical options are available, the rest of the world isn’t as advanced in treatment accessibility. Our microarray needle transdermal patch, which we’ve patented and hold exclusive rights to from the University of Pittsburgh and Carnegie Mellon, has even greater appeal in other parts of the world. Asia Pacific is an important target, and we’re exploring collaborations.
Additionally, we’ve brought in a new Chief Medical Officer from GSK, Faisal Mehmud, who will enhance our ability to advance the study. We’re moving forward at full speed.
When you say you’re moving quickly, you really are. You’re hoping to have some interim data potentially out in 2025, right?
We plan to conduct an internal debrief in early Q1 of 2025. Our confidence comes from our 2021 phase one safety and tolerability study, where six of 13 patients showed a complete clinical response. If we can achieve this with six patients, we’re confident we can do it with 60.
We also believe our novel therapy should receive a fast-track designation from the FDA and become a pivotal trial. We’re seeking a Type C meeting with the FDA in late Q1 or early Q2 of 2025 to align further on our pathway. Interim data should be available before then, and we hope to share more good news with your viewers soon.
Quotes have been lightly edited for style and clarity