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Curasight Announces protocol update for the Phase I uTREAT trial in Aggressive Brain Cancer (Glioblastoma)
Copenhagen, 27 July 2026 - Curasight A/S ("Curasight" or "the Company" - TICKER: CURAS) announces a protocol amendment to the ongoing Phase I clinical trial evaluating uTREAT® in patients with glioblastoma. The amendment has been submitted to the relevant regulatory authorities and is pending approval
The proposed amendment is intended to optimize the clinical study design and broaden the information obtained to design next phase studies.
The key proposed changes include:
- Administration of uTREAT® without blood-brain barrier disruption through mannitol for newly enrolled patients. Participants enrolled under the amended protocol will therefore constitute a separate cohort receiving uTREAT® without blood-brain barrier disruption. Comparison with the first cohort, will gain information of the effect of blood-brain barrier disruption.
- Increasing the lowest number of patients to be included to allow for at least 6 patients dosed with uTREAT® without blood-brain barrier disruption.
- General anaesthesia will be introduced during the neurointerventional procedure for participants enrolled under the amended protocol to optimize working conditions and thereby the precise administration of uTREAT®. Short-term general anesthesia is considered safe in brain-tumor patients.
The protocol amendment has been developed in close collaboration with the investigators and is based on experience gained during the ongoing trial and reflects a desire to further optimize the study design with additional data that will benefit the design of next phase studies.
" The proposed amendments are intended to strengthen the scientific value of the study while exploring the potential of uTREAT® without blood-brain barrier disruption. If successful, this would simplify future clinical implementation and broaden the potential applicability of the treatment." Says Ulrich Krasilnikoff, CEO of Curasight.
The proposed changes are subject to approval by the relevant regulatory authorities and ethics committees before implementation.
The Company expects that the protocol amendment will extend the duration of patient enrolment due to the increased number of participants. Curasight will provide further updates as material developments occur.
About Curasight's uPAR theranostic platform
Curasight's uPAR theranostic platform combines two key technologies - uTRACE® and uTREAT® - both targeting uPAR. uTRACE® is designed to deliver sensitive imaging for diagnosis, while uTREAT® offers a targeted radiopharmaceutical therapy 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 is 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 patients with primary brain tumors are children. The prognosis for individuals with glioblastoma is very poor, as approximately 50% of patients die within 14 months, and after five years from diagnosis, only 5-10 % are still alive. The cornerstone in GBM treatment is radical surgery followed by radiation and concomitant chemotherapy (Stupp regime). uTREAT® could potentially complement current radiation strategies and reduce radiation exposure to healthy brain tissue due to more specific tumor tissue targeting.