Curasight A/S (Spotlight Stock Market:CURAS), a clinical stage radiopharmaceuticals company based in Denmark, announced on Tuesday that the European Medicines Agency has approved its clinical trial application for a phase 1 study of uTREAT in glioblastoma patients.
The study is designed to evaluate uTREAT as a targeted radiopharmaceutical therapy for patients with newly diagnosed or suspected glioblastoma. First patient dosing is expected in the fourth quarter of 2025.
With this milestone, Curasight is now advancing both its diagnostic platform, uTRACE, and its therapeutic platform, uTREAT, into clinical development. Together, these platforms target the uPAR receptor, aiming to deliver a combined diagnostic and therapeutic solution for cancer treatment.
The company noted that recently published investigator-initiated data demonstrated that 94% of grade 4 gliomas, including glioblastomas, are uPAR-positive, highlighting the potential of Curasight's theranostic approach.
Glioblastoma and other high-grade gliomas remain among the most challenging brain cancers to treat, with poor survival rates and limited therapeutic advances. Approximately 30,000 glioblastoma cases are diagnosed annually across the United States and Europe, and current therapies rely heavily on external beam radiation. uTREAT is being developed as a more targeted option that could reduce reliance on conventional radiation and minimise damage to healthy brain tissue.
Curasight secures approval for phase 1 trial of uTREAT in glioblastoma patients
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