Curasight A/S has submitted a Clinical Trial Application (CTA) to the European Medicines Agency for a Phase 1 trial evaluating uTREAT as a targeted radiopharmaceutical therapy for glioblastoma, the most aggressive form of brain cancer. The submission through the Clinical Trials Information System pathway represents a significant milestone in developing treatment options for a cancer with devastating outcomes and limited therapeutic advances.
Addressing Critical Unmet Medical Need
Glioblastoma presents one of oncology's most challenging treatment landscapes, with approximately 30,000 patients diagnosed annually across the United States and European Union. The disease carries an exceptionally poor prognosis, with approximately 50% of patients dying within 14 months of diagnosis and only 5% surviving five years. Despite decades of research, treatment outcomes have shown essentially no improvement over recent years.
"The cancer has a poor prognosis, with essentially no improvement in outcome over the last decades. Accordingly, there is a significant unmet medical need, and we hope that uTREAT will prove to be a game-changer for patients with this aggressive cancer," said Ulrich Krasilnikoff, CEO of Curasight.
Strong Biological Rationale from Recent Data
The therapeutic approach is supported by recently published investigator-initiated Phase II uPAR-PET data that demonstrated 94% of Grade 4 gliomas, including glioblastomas, were uPAR-positive. This high expression rate of the urokinase plasminogen activator receptor provides strong biological rationale for targeting this pathway with uTREAT's radiopharmaceutical approach.
The uTREAT platform represents part of Curasight's integrated theranostic solution, combining diagnostic imaging through uTRACE with targeted treatment capabilities. This dual approach aims to improve both diagnosis and treatment of cancers expressing the uPAR receptor.
Trial Design and Execution Strategy
The Phase 1 trial will investigate uTREAT as a targeted radiation therapy in glioblastoma patients, with primary objectives focused on characterizing the safety profile of this novel approach. Participants will include patients with verified or suspected glioblastoma scheduled for brain surgery, with the trial design informed by previous research with uTRACE and discussions with key opinion leaders.
Curasight has selected Premier Research as the contract research organization to conduct the international trial. "We are very pleased to be working with Premier Research – a globally represented Clinical Research Organization and a company with proven experience in the very specialized field of conducting international diagnostic and therapeutic trials with radiopharmaceutical agents," Krasilnikoff noted.
John Ratliff, CEO of Premier Research, expressed confidence in the partnership: "We are delighted to partner with Curasight – a leader in the field of theranostics - we look forward to working with their innovative radiopharmaceutical technology."
Potential to Transform Treatment Paradigm
The targeted nature of uTREAT could potentially address current treatment limitations in glioblastoma management. External beam radiation serves as a cornerstone therapy for brain cancers, but uTREAT's specific tumor tissue targeting could potentially replace or reduce external beam radiation use, thereby lowering side effects to healthy brain tissue.
The trial marks Curasight's evolution into a therapeutic company, expanding beyond its diagnostic capabilities. First patient dosing is expected in the second half of 2025, representing a critical step toward potentially providing new treatment options for patients facing this aggressive cancer with limited therapeutic alternatives.
