Wednesday, December 22, 2021
Telix is pleased to announce a clinical data access agreement with the Olivia Newton-John Cancer Research Institute relating to a prospective clinical trial investigating the use of O-(2-[18F]fluoroethyl)-L-tyrosine or 18F-FET to image glioblastoma patients with positron emission tomography . 18F-FET is under development by Telix as a complementary diagnostic agent to its TLX101 glioblastoma therapeutic candidate.
The FET-PET in Glioblastoma (“FIG”) Study (ANZCTR Trial ID: ACTRN12619001735145) is a prospective, multicentre study which aims to definitively establish the role of FET-PET in the management of glioblastoma, a type of brain cancer.
Glioblastoma (GBM) is the most common primary brain cancer in adults representing approximately 50% of brain tumours. Imaging plays a key role in diagnosis, radiotherapy planning, and monitoring of treatment response in GBM.
ONJCRI is leading the FIG Study with an Australian consortium and has secured over $3 million in research grant funding from the Medical Research Future Fund (MRFF), Cure Brain Cancer Foundation, and MRFF-Australian Brain Cancer Mission. Telix is participating in the FIG Study as both a commercial collaborator and part funder, in return for access to final study data to support the further development and registration of TLX101-CDx. Telix funding will specifically support an observational study (registry) which will collect data demonstrating the value of FET-PET imaging in brain cancer patients.
The FIG study, which will recruit up to 210 newly diagnosed adult GBM patients, is addressing the use of FET-PET imaging throughout a patient’s treatment journey together with current standards of care. Primary endpoints are to assess FET-PET’s impact on radiotherapy planning and understand the accuracy of FET-PET in assessing disease progression.
Clinical Trial Co-Chair for the FIG Study, Professor Andrew Scott of the ONJCRI, and Department of Molecular Imaging and Therapy at Austin Health said, “Imaging is integral to effective diagnosis, staging and determination of the treatment pathway for all cancers, but is vitally important in glioblastoma which is very aggressive and can be difficult to treat. This ground-breaking study will use 18F-FET, a new PET tracer which can show us if tumour cells are active. This is a more functional imaging technique compared to magnetic resonance imaging (MRI), the current standard imaging tool, and could potentially provide a powerful imaging biomarker for the management of brain cancer and improve survival rates.”
Telix CEO, Dr. Christian Behrenbruch added, “We are pleased to have joined forces with ONJCRI and this Australian consortium evaluating FET-PET, which provides a superb example of the type of initiative that we can pursue thanks to the Australian Federal Government’s tax credit scheme for domestic R&D activities. We are hopeful that the clinical data will support Telix’s global regulatory submissions for TLX101-CDx, whilst also enabling public dissemination of data in a way that can be robustly mined for the benefit of patients suffering from this disease with particularly poor prognosis.”