Medicus Pharma (NASDAQ:MDCX) earlier this week highlighted encouraging data from its Phase 2 clinical trial evaluating SkinJect, a non-invasive treatment designed to address basal cell carcinoma, the most common form of skin cancer.
Speaking to Proactive, chief executive Raza Bokhari said the latest dataset suggests the company’s microneedle-based therapy could significantly reduce the need for surgical intervention in many patients.
Proactive: Welcome back inside our Proactive newsroom. And joining me now is Dr Raza Bokhari. He is the CEO of Medicus Pharma. Dr Bokhari, it's nice to see you again. How are you?
Raza Bokhari: I'm doing really well. Thank you so much. The spring is finally around the corner.
It is. That's always good news. And that's what you're here to share—more details from your Phase 2 clinical trial for your SkinJect cancer therapy. We talked last week about some of the topline results, and you now have more data to share today. Very positive news from what you're seeing?
Absolutely. We couldn't be more excited about what we have seen in the Phase 2 dataset for our novel therapy to treat basal cell carcinoma non-invasively, which is an unmet medical need. The data shows that three out of four treated patients very likely would not require Mohs surgery.
As your viewers know, there are nearly 5 million new cases diagnosed every year. There are about a million more procedures that could be carried out in the United States because there are not enough trained Mohs surgeons. So there is a backlog and a clear unmet medical need.
Our proof-of-concept study focused on clinical clearance from the outset. In the 200 microgram cohort, at day 57 following excisional biopsy, we saw 73% clinical or visual clearance. For a clinician, that is very promising.
Three out of four treated patients do not require Mohs surgery and instead go on a follow-up protocol. Some may come back if there is recurrence, but it helps address the backlog and gives us enough data to enter an end-of-Phase 2 meeting with the FDA to design the pivotal study. It also helps accelerate partnering discussions.
Our microneedles themselves are patent protected and have biological activity. When they are tip-loaded with doxorubicin, they create a higher level of clinical clearance. So this is a very promising outcome for us.
I was reading more about the study and noticed that there was an active placebo used. That's not very common. Was that designed specifically that way?
Yes. It’s a novel study. The description says it is a placebo-controlled double-blind study, but the placebo—the microneedle array without doxorubicin—is also an active arm. It’s not a blank.
Our patents cover both the composition and the method of use for the carboxymethyl cellulose microneedle arrays, which have biological activity themselves. When they are tip-loaded with doxorubicin, they become even more effective.
In our Phase 1 study completed in 2021, we tested doses from 25 micrograms to 200 micrograms. In the current study we used 100 micrograms and 200 micrograms and compared those with the microneedle array without doxorubicin.
The data clearly shows that the 200 microgram dose provides the strongest separation in clinical clearance. Histological clearance is a regulatory factor, and the FDA will guide how much separation is needed there. But from a clinician’s perspective, seeing visual clearance in three out of four patients means many may not need Mohs surgery. That sets the stage for what we believe could be a blockbuster.
That FDA meeting will happen fairly soon?
We have begun the process. We still need the clinical study report. Before the end of the first half of the year we should have our request with the FDA submitted, possibly with a meeting scheduled. If not in the first half, then early in the second half—around June or July. Hopefully before that we could also secure a strategic partner to co-develop the therapy going forward.
Important work still ahead. Dr Bokhari, great update and explanation. Thank you for your time.
Thank you so much for having me back on your program.
Quotes have been lightly edited for clarity and style