Medicus Pharma (TSX-V:MDCX) CEO Raza Bokhari talked with Proactive about their recent FDA Phase 2 clinical protocol submission. This submission included updated designs and comprehensive data addressing the safety profile, manufacturing control, and stability of their treatments.
Bokhari emphasized the use of artificial intelligence in enhancing their noninvasive approach to treating basal cell carcinoma, aiming to make treatments more effective, painless, and aesthetically pleasing.
Proactive: You had some significant news about the updated Phase Two clinical protocol submission to the FDA. Can you explain the regulatory reason behind this submission? Additionally, could you elaborate on what was included in the submission, particularly regarding the use of artificial intelligence?
Raza Bokhari: As part of our clinical development program earlier this year in January, we submitted an amended phase two clinical design to the FDA. We received comments back in March, and the FDA requested additional information. These comments were non-clinical, which was a good indication right from the outset.
On Friday, we submitted a comprehensive package to the FDA, providing all the relevant information they needed regarding the safety profile, the updated investigator brochure, as well as the CMC (Chemistry, Manufacturing, and Controls) information, including stability and security data. We have essentially satisfied all the requirements.
We are now very confident that we will get the nod from the FDA to start randomizing patients, hopefully before the end of this quarter.
Could you explain why AI is so important and how it has the potential to accelerate your progress so significantly?
Our treatment regimen involves a disruptive, noninvasive method to treat basal cell carcinoma of the skin, which is the most common cancer. Currently, it is treated, at least in the Western Hemisphere, through surgical intervention called Mohs surgery. This method is expensive, not very pleasing, and quite painful. Despite this, 7.5 million Mohs surgery cases happen every year in the United States.
Our treatment regimen delivers a known chemotherapeutic agent directly to the site of the lesion, curing the cancer in a promising, noninvasive way. It is more effective, aesthetically pleasing, and painless. We are very excited about our clinical design, which includes six clinical sites. One of these sites is using artificial intelligence-powered software for diagnostic purposes and confocal microscopy for conclusive histological examination.
Our goal is to make the treatment completely noninvasive. We have supplementary endpoints in our clinical design that involve conventional investigative biopsies to diagnose basal cell carcinoma when recruiting patients, as well as histological examinations to demonstrate that the cancer has been cured. By using cutting-edge tools as supplemental points, we hope to gather enough data to correlate with traditional means, aiming for a completely noninvasive treatment from start to finish. We are extremely excited to have incorporated these next frontiers of medicine driven by artificial intelligence in our clinical design submitted to the FDA.
We should also mention that we recently closed on a financing round, which is another positive step for the company. Since listing on the Toronto Stock Exchange with a modest raise of $6 million, we have raised nearly $12 million through private placements. This has been very reassuring as the market has received us well. Of the nearly $12 million raised, $8 million came from a Philadelphia-based investment fund focused on cutting-edge biotech investments, and we are their first investment.
Drug development is an expensive business, and it is crucial to continually raise capital in an orderly fashion to bring novel therapies to market. While we are satisfied with our progress over the last nine months, our work has just begun, and there is still much more to be done.
Quotes have been lightly edited for style and clarity