Curasight A/S announced the enrolment of the first patient in the Phase 2 trial using uTRACE® PET imaging technology for the improved diagnosis in prostate cancer. The news triggers the second USD 500.000 milestone under the agreement with Curium Inc., signed in May 2023. uTRACE® is part of Curasights Theranostic platform using the uPAR target for improved diagnosis and treatment (uTREAT®) of certain cancers.

Under the terms of the deal with Curium signed in May 2023, Curasight will develop its proprietary uTRACE® technology for use in prostate cancer until regulatory approval is granted in the EU and USA with Curium responsible for the commercial manufacture of uTRACE® and world-wide commercialization. Curasight is eligible to receive up to mUSD 70 in development and commercial milestones as well as double-digit percentage royalties on sales in major markets upon eventual commercialization. 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.