Oxford 31 March 2016 - Blue Earth Diagnostics Ltd. (“BED”), a private diagnostics company, announces the commencement of the BED-004, or FALCON, trial of fluciclovine (18F) in the management of patients with recurrent prostate cancer. The trial, jointly funded by Innovate UK and BED is being conducted at six leading institutions in the UK; Oxford University Hospitals NHS Foundation Trust, University College London, Kings College London, The Royal Marsden NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust and Greater Glasgow Health Board.
Fluciclovine (18F) is a synthetic amino acid investigational positron emission tomography (PET) radiopharmaceutical being investigated in the imaging of various cancers by BED, with its lead product in prostate cancer patients currently under review by the Food & Drug Administration (FDA) in the USA and European Medicines Agency in Europe.
Jonathan Allis, CEO of Blue Earth Diagnostics Ltd., said:
“Blue Earth Diagnostics’ mission is to transform the clinical management of cancer through the development of new molecular imaging technologies and we are delighted to be working with some of the leading UK cancer hospitals in this new prostate cancer study. It is an exciting time in the Company’s development with our lead product under review in the USA and Europe and we look forward to the potential approval of fluciclovine and to supporting diagnostic imaging options for other cancer patients.”
Professor Fergus Gleeson, Professor of Radiology at Oxford University said:
“I am delighted to be the Chief Investigator on this important study. FALCON demonstrates collaborative funding from government, the NHS and industry, and collaborative working amongst doctors across the UK in helping to determine the best treatment for patients with recurrent prostate cancer. Using a novel imaging agent, fluciclovine (18F), the study aims to determine the extent of the patient’s disease and optimise their treatment.”
Blue Earth Diagnostics Ltd. was formed in March 2014 and is funded by Syncona LLP. The Company licensed the PET imaging agent fluciclovine (18F), also known as FACBC, from GE Healthcare.
