Curasight A/S announced submission of clinical trial application (CTA) to the European Medicines Agency (EMA) for the investigation of uTRACE® in a phase 2 trial as a noninvasive alternative or supplement to traditional biopsies in prostate cancer patients in active surveillance. The CTA was submitted under the new application pathway Clinical Trials Information System (CTIS) and paves the way for patients to be recruited into the phase 2 trial of uTRACE® in prostate cancer which is part of the collaboration with Curium, announced in May 2023. About the Phase 2 trial with uTRACE® in prostate cancer: The primary objective of the phase 2 trial is to investigate Curasight?s first-in-class PET tracer, 64Cu-DOTA-AE105 as a non-invasive grading tool of prostate cancer patients that are followed in active surveillance.

Patients in active surveillance are continuously monitored for changes in the aggressiveness of their prostate cancer and can be followed for years without identifying the need for treatment. The trial design is informed from research and earlier studies with uTRACE® as well as protocoldiscussions with the US Food and Drug Administration (FDA). The phase 2 trial is part of the development framework agreed under the deal with Curium.