Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma, has announced the submission of an updated Phase 2 Investigational New Drug clinical protocol to the United States Food and Drug Administration (FDA). This protocol targets the non-invasive treatment of basal cell carcinoma of the skin through the use of micro-needle arrays containing doxorubicin, a development spearheaded by Medicus Pharma’s wholly owned portfolio company, Skinject, Inc.
The updated submission includes significant enhancements to the clinical protocol, with particular focus on the Chemistry, Manufacturing, and Controls (CMC) aspects. Detailed stability and sterility information have been incorporated, addressing previous clinical non-hold comments from the FDA. These updates are designed to ensure a comprehensive and robust response to regulatory feedback, bolstering the protocol's potential for approval.
Dr. Bokhari highlighted that the revised protocol integrates innovative elements such as artificial intelligence and confocal microscopy as supplementary endpoints at one of the clinical sites. The inclusion of these advanced technologies aims to provide deeper insights and improved accuracy in the clinical outcomes, setting a new standard for rigor in clinical research.
Medicus Pharma is optimistic that the updated protocol is well-positioned to receive FDA approval, which would allow for the commencement of participant randomization possibly before the end of this quarter. This development is a testament to the company's commitment to advancing innovative treatments for skin cancer and improving patient outcomes through cutting-edge technology and rigorous clinical research.
The submission of this updated protocol marks an important milestone in the field of non-invasive cancer treatment. Should FDA approval be granted, it could pave the way for new, less invasive treatment options for patients suffering from basal cell carcinoma, potentially transforming the landscape of skin cancer therapy.
By integrating AI and advanced imaging techniques, Medicus Pharma is not only addressing regulatory requirements but also pushing the boundaries of what is possible in clinical research. The potential impact of these advancements could extend beyond skin cancer treatment, influencing broader oncological research and patient care practices globally.
