Curasight gets green light from EMA in phase II prostate cancer trial
The partnership deal closed with Curium last year marks the most important milestone for Curasight to date. Now, the European Medicines Agency (EMA) has approved the clinical trial application for the phase II study with uTRACE in prostate cancer.
– The acceptance illustrates the strong progress being made in developing uTRACE, CEO Ulrich Krasilnikoff comments.
Copenhagen-based biotech Curasight focuses on pioneering advancements in cancer theranostics through their proprietary technology targeting the uPAR receptor, a key biomarker for cancer aggressiveness. The company has developed radiopharmaceuticals – the PET-tracer ligand uTRACE and the radioligand therapy uTREAT – serving as non-invasive tools to localise, evaluate and treat multiple types of cancer.
The strategic alliance with Curium, a global leader in radiopharmaceuticals, revolves around the application of uTRACE in diagnosing prostate cancer, potentially offering a less invasive alternative to conventional biopsy methods used in ongoing patient monitoring. Curasight recently received the first milestone payment of a potential total of USD 70 million for the validation of the GMP batch of finished product.
CTA approved
Now, the European Medicines Agency has approved the company´s clinical trial application (CTA), paving the way for a phase II trial with uTRACE in prostate cancer patients.
– The acceptance of the CTA illustrates the strong progress being made in developing uTRACE as a potential solution providing better diagnosis and categorisation of tumours for prostate cancer patients, comments Curasight CEO Ulrich Krasilnikoff.
– It´s also testament to the positive collaboration we have with Curium.
Entering phase II in Q2
The trial is part of the agreed development framework, with Curasight being responsible for the development and Curium heading manufacturing and commercialisation. Preparations are currently underway, with the study aiming at investigating uTRACE as a non-invasive diagnostic tool for the follow up and grading of prostate cancer patients in active surveillance. These patients are often monitored over several years to keep track of the cancer’s aggressiveness.
The study will investigate the Copper-64-labeled version of uTRACE, specifically designed for the US market. One advantage of this version of uTRACE, compared to the Gallium-68-version, is the longer shelf-life, which allows for central distribution from few production sites.
The study design is based on insights gained from previous research and studies conducted with uTRACE, alongside detailed protocol discussions with the US Food and Drug Administration.
– We look forward to dosing the first patient in this phase II trial with uTRACE and to continuing momentum in our efforts to bring uTRACE as a new option for patients, Krasilnikoff says, expecting the first patient to be dosed in the phase II trial in the second quarter of 2024.
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