Medicus Pharma CEO discusses latest skin cancer trial results - ICYMI

Medicus Pharma (NASDAQ:MDCX) CEO Raza Bokhari talked with Proactive about the latest progress in the company’s ongoing clinical trials for its innovative skin cancer treatment.

The company is developing a non-invasive microneedle-based therapy designed to treat basal cell carcinoma by delivering doxorubicin directly to the lesion site.

Bokhari shared that the company’s Phase 2 proof-of-concept study for SKNJCT-003 has now surpassed 50% patient recruitment across nine US sites, with interim analysis showing over 60% complete clinical clearance among randomized patients.

Proactive: All right, welcome back inside our Proactive newsroom. Joining me now is Dr. Raza Bokhari, CEO of Medicus Pharma. Dr. Bokhari, great to see you again. How are you?

Raza Bokhari: Thank you for having me back on your program. It’s always a pleasure to come back to Proactive.

Good to have you here. You’ve got some significant news today regarding positive trends in your current clinical trial, SKNJCT-003. First, can you explain what SKNJCT-003 is and what these positive trends are?

Thank you. As most of your viewers may recall, our lead asset at Medicus Pharma is focused on developing a non-invasive treatment for basal cell carcinoma. Our technology involves a microneedle array that is tip-loaded with doxorubicin to deliver therapy directly to the lesion site.

In 2024, we initiated a Phase 2 proof-of-concept study across nine sites in the United States, with patient recruitment starting last summer. Earlier this quarter, we crossed 50% patient recruitment and today, we shared our interim analysis results, which show over 60% complete clinical clearance among randomized patients.

And this information will be submitted to the FDA, correct?

Yes, the interim analysis is part of a package we are submitting to the FDA for a Type C meeting, which we hope to hold before the end of Q2. Our goal is to obtain regulatory guidance on the pathway to registration under the 505(b)(2) framework, since doxorubicin is already approved for other cancer indications. We also believe our therapy qualifies for a fast-track designation.

Additionally, we anticipate that our pivotal trial will require between 200 and 400 patients, which is in line with our current Phase 2 study. If successful, we aim to file a New Drug Application (NDA) by 2027.

Alongside this, you are also launching another clinical trial for SKNJCT-004 in the UAE. Can you tell us more about this study?

Absolutely. We are excited to expand beyond the U.S. because basal cell carcinoma is a global issue, with millions of new cases every year. The UAE is becoming a biotech innovation hub, making it an ideal location for our study.

This trial will replicate our SKNJCT-003 study but with a smaller patient group of 36 instead of 60. We are conducting the study in partnership with Cleveland Clinic Abu Dhabi and American Hospital Dubai, ensuring compliance with FDA-equivalent standards.

And if successful, this could open doors to other regions, correct?

Yes, exactly. We announced in December that we are also exploring partnerships in the Asia-Pacific region. The UAE trial is a strategic step in that direction. It also positions us to attract global biotech investors and strategic partners beyond traditional big pharma.

Quotes have been lightly edited for clarity and style