Medicus Pharma (TSX-V:MDCX) has announced the submission of an updated clinical trial protocol to the United States Food and Drug Administration (FDA).
This protocol is for a Phase 2 trial of a new treatment for basal cell carcinoma (BCC), a common type of skin cancer. The treatment involves using micro-needle arrays containing doxorubicin (D-MNA), developed by its subsidiary, Skinject, Inc.
The submission to the FDA includes updates to the clinical trial design, as well as information on the chemistry, manufacturing, and control processes for the drug. It also contains data on the drug's stability and sterility. These updates address comments from the FDA received in March 2024.
"This Phase 2 clinical protocol, in its final form, is a comprehensive design, well positioned to get the nod from the FDA to commence randomizing participants hopefully before the end of this quarter," said Dr Raza Bokhari, chairman and CEO of Medicus.
Medicus provided safety data from a previous Phase 1 study completed in March 2021. This data supports the use of two doses of the drug, 100 micrograms (μg) and 200 micrograms (μg). The company also updated its investigator brochure with safety information from earlier clinical trials.
The new Phase 2 trial will be a randomized, double-blinded, placebo-controlled study. This means that participants will be randomly assigned to different treatment groups, and neither the participants nor the researchers will know who is receiving the actual treatment or a placebo. The trial will include up to 60 people with nodular BCC, a specific type of skin cancer.
Participants will be divided into three groups: one receiving a placebo, one receiving a low dose of 100 micrograms of D-MNA, and one receiving a high dose of 200 micrograms of D-MNA. The high dose is the same as the maximum dose used in the previous Phase 1 study, which found the treatment to be safe and well-tolerated.
The results from the initial trial showed that the drug was well-tolerated at all dose levels, with no serious side effects or significant health issues. Six participants experienced complete responses, meaning their BCC disappeared completely by the end of the study.
The updated Phase 2 protocol also includes new technologies to improve the accuracy of the trial. One clinical site will use artificial intelligence (AI) and confocal microscopy, a technique for detailed imaging, as supplementary methods to assess the treatment's effectiveness. This addition aims to eliminate the need for invasive diagnostic procedures.
Bokhari said: "We are very excited to incorporate artificial intelligence-powered software and confocal microscopy as supplemental endpoints in one of the clinical sites to improve the assessment accuracy of the clinical program and hopefully also eliminate any invasive intervention even at the diagnostic stage, making our treatment regimen completely non-invasive from start to finish."