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- Phase 1 study in aggressive brain cancer (Glioblastoma) is the first clinical trial investigation of uTREAT®
- Site given green light by European Medicines Agency (EMA) and is now open for patient enrollment - first patient dosing expected Q4 2025
- Both arms of Curasight's theranostic approach investigating better treatment (uTREAT®) and diagnosis (uTRACE®) of certain cancers are now in clinical development
Copenhagen, 26 November 2025 - Curasight A/S ("Curasight" or "the Company" - TICKER: CURAS), a clinical stage radiopharmaceuticals company, today announced its phase 1 trial investigating uTREAT® in aggressive brain cancer is now open for patient enrollment.
Regulatory approval from the Health Authority and ethical committee approval has been obtained, and all practical and logistical preparations at the trial site have been completed. Dosing the first patient is expected in the coming weeks.
The phase 1 trial is part of Curasight's theranostic strategy developing more gentle and targeted diagnosis and treatment of certain types of cancer.
"It is a very exciting stage in the development of uTREAT, that we are now ready to enroll patients and progress the development of uTREAT as a potential more targeted therapeutic solution for patients with aggressive brain cancer. There is a high unmet medical need for new treatments for brain cancer, and we look forward to enrolling the first patient very soon" said Curasight's CEO Ulrich Krasilnikoff.
About the Phase 1 trial with uTREAT in brain cancer
The trial aims to investigate Curasight's uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from clinical studies with the ligand forming the backbone of uTRACE®, demonstrating that almost all GBM patients (94%), express uPAR on the tumour.
About the uPAR theranostic platform
Curasight's uPAR theranostic platform combines two key technologies - uTRACE and uTREAT both targeting the uPAR receptor. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight's ambition is to develop both uTRACE and uTREAT to improve diagnosis and treatment of uPAR-expressing cancers.
About high grade glioma
Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.