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Medicus Pharma adds UK site to Skinject study - ICYMI
Proactiveinvestors NAยท 2025-11-15 20:11
Core Viewpoint - Medicus Pharma is expanding its Phase 2 clinical trial for Skinject, a noninvasive therapy for basal cell carcinoma, by including UK sites, which enhances geographical diversity without the costs of a separate study [1][2][5]. Group 1: Clinical Trial Expansion - The UK Regulatory Authority has approved the inclusion of UK sites in the ongoing Skinject 003 study, which initially launched in the summer of 2024 across nine U.S. sites [1][4]. - The expansion allows the company to add at least one UK site to the existing 90-patient study, making it more cost-effective compared to starting a new trial [6][8]. - A separate 36-patient study is currently underway in the Middle East through Cleveland Clinic Abu Dhabi [2][5]. Group 2: Regulatory and Development Progress - The company has completed a Type-C meeting with the FDA and anticipates a Fast-Track designation following its end-of-Phase 2 meeting in Q1 2025 [2][8]. - The groundwork laid in the Middle East, UK, and U.S. is expected to contribute to a robust pivotal study design and execution [9]. - The company is optimistic about positive findings from the trial, which could lead to a pivotal study [5][9].