drugset / Press release

Blue Earth Diagnostics begins fluciclovine (18F) studies in Recurrent Prostate Cancer Patients

2016-03-31 · Blue Earth Diagnostics · original blueearthdiagnostics.com ↗

BLUE EARTH DIAGNOSTICS BEGINS FLUCICLOVINE (18F) STUDIES IN RECURRENT PROSTATE CANCER PATIENTS March 31, 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. Further information: Blue Earth Diagnostics Jonathan Allis +44 (0) 20 7611 5734 JW Communications Julia Wilson +44 (0) 781 8430877 Notes for Editors: About Blue Earth Diagnostics Ltd. BED is a private, UK based, diagnostics company focused on the development and commercialisation of positron emission tomography (PET) agents. The BED team is made up of industry experts in the field of imaging, chemistry, clinical development, regulatory affairs and commercialisation of nuclear medicine products. For further information please visit: www.blueearthdiagnostics.com About Syncona LLP Syncona LLP was founded in 2012 and operates as a healthcare investment company, taking an active role in identifying, developing and funding technologies with the potential to significantly impact the healthcare market of the future. Syncona can take the long view when necessary, able to concentrate investment into opportunities as technology is validated. For further information please visit the Company’s website at: www.synconallp.com About positron emission tomography (PET) Positron emission tomography (PET) is a test that uses a special type of camera and a tracer (radioactive chemical) to examine biochemical processes in the body. During the test, the tracer liquid is injected into a vein (intravenous, or IV) in the arm. The tracer moves through the body, where much of it collects in the specific organ or tissue. The tracer gives off tiny positively charged particles (positrons). The camera records the emissions and turns the recording into pictures. PET scan pictures show biological function and are complimentary with computed tomography (CT) scans or magnetic resonance imaging (MRI), which show anatomical information. About Prostate / Recurrent Prostate Cancer Prostate cancer is the second leading cause of cancer in men worldwide. Most primary prostate cancer can be successfully treated, but the disease does recur in approximately 35% of patients. In some patients the recurrent disease is detectable only because their PSA rises, however the location of the recurrence cannot be located by conventional imaging. This severely limits making the correct choice for these patients.

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