Medicus Pharma Submits Updated Phase 2 Clinical Protocol for Skin Cancer Treatment to FDA

Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma, has announced the submission of a comprehensive and updated Phase 2 Investigational New Drug clinical protocol to the United States Food and Drug Administration (FDA). This updated protocol aims to offer a non-invasive treatment for basal cell carcinoma of the skin using micro-needle arrays containing doxorubicin. These micro-needle arrays have been developed by Medicus Pharma’s wholly owned portfolio company, Skinject, Inc.

The submission includes significant updates to the clinical protocol, particularly in the areas of Chemistry, Manufacturing, and Controls (CMC). Detailed stability and sterility information have been added to support the clinical trial. Additionally, the new protocol addresses clinical non-hold comments previously received from the FDA, ensuring a comprehensive response to regulatory feedback.

In an interview with Proactive, Dr. Bokhari explained that the revised protocol incorporates innovative elements such as artificial intelligence and confocal microscopy as supplementary endpoints at one of the clinical sites. These advanced technologies are expected to provide deeper insights and improved accuracy in the clinical outcomes.

Medicus Pharma is optimistic that the updated protocol will receive FDA approval, which could lead to the commencement of participant randomization potentially before the end of this quarter. This submission underscores the company's commitment to advancing innovative treatments for skin cancer and improving patient outcomes through cutting-edge technology and rigorous clinical research.

Dr. Bokhari emphasized that the enhancements in the clinical protocol reflect Medicus Pharma’s dedication to meeting the highest standards of clinical research. The incorporation of artificial intelligence and confocal microscopy represents a significant advancement in the methodology for assessing clinical outcomes, likely setting a new benchmark in the treatment of basal cell carcinoma.

The successful approval and subsequent clinical trial commencement would mark a crucial milestone for Medicus Pharma and its partner Skinject, Inc. It would not only validate their technological innovations but also potentially offer a new, non-invasive treatment option for patients suffering from basal cell carcinoma, thereby addressing a significant unmet medical need.