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- Phase 2 study is part of the collaboration between Curasight and Curium announced earlier this year
- Appointment of clinical CRO marks further step in progress in development of uTRACE as a potential new diagnostic solution for prostate cancer
Copenhagen, December 13, 2023 - Curasight A/S ("Curasight" or "the Company" - TICKER: CURAS) today announced it has signed an agreement with ABX-CRO, an experienced international clinical research organization serving the pharmaceutical industry, to run the phase 2 study investigating uTRACE[®] in improving the diagnosis of prostate cancer.
The Phase 2 study is an important part of the agreement between Curasight and Curium, for the manufacture and commercialization of uTRACE in prostate cancer, announced earlier this year on May 1[st] 2023.
"We are very pleased to be working with the German headquartered clinical research organization ABX-CRO, a company with proven experience in the very specialized field of conducting international diagnostic and therapeutic trials with radiopharmaceutical agents. We believe ABX-CRO is the optimal partner to secure the efficient and effective execution of this trial, which is an important element of our collaboration with Curium for uTRACE in prostate cancer" said Curasight's CEO Ulrich Krasilnikoff.
"We are delighted to partne with Curasight - a leader in the field of theranostics - we look forward to working with their exciting radiopharmaceutical technology. We are confident we can deliver a high level of operational excellence to ensure the optimal execution of this important Phase 2 trial with uTRACE[®]." said ABX-CRO's CEO Dr. Andreas Kluge.
About the Phase 2 trial with uTRACE in prostate cancer
The primary objective of this 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 trial will be conducted in two parts, with the first part of the trial conducted at three different University hospitals in Denmark and Sweden. For part 2, the trial will be expanded to also include University hospitals in Germany as well as transatlantic hospitals in the US.
About the uPAR diagnostic platform
The uTRACE[®] platform is part of Curasights uPAR theranostic solution, made up of its uTRACE[®] diagnostic technology and its uTREAT® targeted treatment technology. In prostate cancer, uTRACE[®] is presently developed for diagnostic purposes only.
About ABX-CRO Advanced Pharmaceutical Services
ABX-CRO is a German based clinical research organization (CRO) specialized in nuclear medicine and with strong focus in oncology, neuroscience and imaging indications, and with experience in investigations of prostate imaging agents.