Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into a clinical data access agreement with the Olivia Newton-John Cancer Research Institute (ONJCRI) 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 (PET) (FET-PET).
MELBOURNE, Australia, Dec. 22, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into a clinical data access agreement with the Olivia Newton-John Cancer Research Institute (ONJCRI) 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 (PET) (FET-PET). 18F-FET is under development by Telix (referred to as TLX101-CDx) 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 consortium1 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 across Australia, 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 Chief Executive Officer, 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.”
About Glioblastoma
Glioblastoma, also known as glioblastoma multiforme (GBM), is the most aggressive form of primary brain cancer, with approximately 11,000 new cases diagnosed annually in the US.2 The mainstay of treatment for GBM typically comprises surgical resection, followed by combined radiotherapy and chemotherapy. However, despite such treatment, most patients experience recurrence, with an expected survival duration of approximately 15 months from diagnosis.3
About TLX101-CDx (18F-FET)
18F-FET has been widely used in clinical research settings while recently, new practice guidelines have been developed for the imaging of gliomas using PET with radiolabelled amino acids, of which 18F-FET is a key enabling radiopharmaceutical.418F-FET targets the amino acid transport system L (LAT) and is therefore highly suitable for use as a complementary diagnostic agent to TLX101, Telix’s therapeutic drug candidate for glioblastoma. 18F-FET was used to select patients and track disease response in Telix’s IPAX-1 Phase I/II clinical trial (ClinicalTrials.gov Identifier: NCT03849105), which recently completed recruitment in Europe and Australia.5
About the Olivia Newton-John Cancer Research Institute
The Olivia Newton-John Cancer Research Institute (ONJCRI) is a leader in the development of experimental and breakthrough cancer treatments. ONJCRI investigates and develops treatments for cancers of the breast, bowel, lung, melanoma, prostate, liver, gastrointestinal tract, and brain. Its researchers and clinicians are actively involved in running clinical trials, giving patients access to potential new treatments including immunotherapies and personalised medicine. For more information visit www.onjcri.org.au.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Switzerland, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com
Important Information
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not beenandwillnotberegisteredundertheUnitedStatesSecuritiesActof1933(the“U.S.SecuritiesAct”),orunderthe securitieslawsofanystateorotherjurisdictionoftheUnitedStatesandmaynotbeofferedorsoldwithintheUnited States,unlessthesecuritieshavebeenregisteredundertheU.S.SecuritiesActoranexemptionfromtheregistration requirements of the U.S. Securities Act isavailable. None of the technologies or products described in this document have received a marketing authorisation in any jurisdiction. This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Chief Executive Officer.The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).
1 Other consortium members: Australasian Radiopharmaceutical Trials Network (ARTnet); Cooperative Trials Group for Neuro-Oncology, The University of New South Wales, The University of Western Australia, The University of Melbourne, The University of Sydney and study sponsor Trans Tasman Radiation Oncology Group.
2 Ostrom QT et al. CBTRUS statistical report. 2013.
3 Ohgaki H et al. Acta Neuropathol. 2005.
4 Law I et al. Joint EANM/EANO/RANO practice guidelines/SNMMI procedure standards for imaging of gliomas using PET with radiolabelled amino acids and [18F]FDG: version 1.0. Eur J Nucl Med Mol Imaging. 2019.
5 ASX disclosure 17/06/21.
