Medicus Pharma CEO Dr. Raza Bokhari Announces Updated Phase 2 Clinical Protocol Submission to FDA
Vancouver, Canada
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July 16, 2024 11:51 AM Eastern Daylight Time
Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma joined Steve Darling from Proactive to announce the submission of a comprehensive and updated Phase 2 Investigational New Drug clinical protocol to the United States Food and Drug Administration (FDA). This protocol aims to non-invasively treat basal cell carcinoma of the skin using micro-needle arrays containing doxorubicin, developed by Medicus Pharma’s wholly owned portfolio company, Skinject, Inc.
The submission features significant updates to the clinical protocol, including enhancements to the supporting Chemistry, Manufacturing, and Controls (CMC), along with detailed stability and sterility information. Furthermore, it addresses the clinical non-hold comments previously received from the FDA, ensuring a robust and thorough response to regulatory feedback.
Dr. Bokhari shared with Proactive that the revised Phase 2 clinical 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 believes that this updated protocol is well-positioned to receive FDA approval, paving the way for the commencement of participant randomization potentially before the end of this quarter. This milestone underscores the company’s commitment to advancing innovative treatments for skin cancer and improving patient outcomes through cutting-edge technology and rigorous clinical research.
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Proactive North America
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