Curasight A/S announced approval of clinical trial application (CTA) from the European Medicines Agency (EMA) for the investigation of uTRACE in a phase 2 trial as a non-invasive alternative or supplement to traditional biopsies in prostate cancer patients in active surveillance. The phase 2 trial is part of Curasight?s collaboration with Curium for uTRACE in prostate cancer, announced in May 2023 and the first patient is expected to be dosed in Second Quarter 2024. The trial is aimed at providing clinical insight into the use of uTRACE as a non-invasive way of providing more accurate diagnosing and grading of prostate cancer, an area with a recognized high unmet medical need. 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 protocol discussions with the US Food and Drug Administration (FDA).  The phase 2 trial is part of the development framework agreed under the deal with Curium. About the uPAR diagnostic platform: The uTRACE platform is part of Curasights uPAR radiopharmaceutical theranostic solution, made up of its uTRACE diagnostic technology and its uTREAT radioligand therapy technology.

In prostate cancer, uTRACE is presently developed for diagnostic purposes only. Curasight?s ambition is to develop both uTREAT and uTRACE to improve diagnosis and treatment solutions of several solid cancers.