Fluciclovine F 18 is an artificial amino acid that has been labelled with F 18 to allow positron emission tomography (PET) imaging. Fluciclovine F 18 appears to be avidly taken up by a number of cancer cell types, including prostate cancer and glioma (a type of brain tumour).
Blue Earth Diagnostics is investigating fluciclovine F 18 as a molecular diagnostic imaging agent for various cancers. It has been evaluated most extensively for disease localisation and detection in prostate cancer patients with suspected biochemical recurrence following earlier treatment.
Blue Earth Diagnostics’ first product, Axumin™ (fluciclovine F 18), was approved by the U.S. Food & Drug Administration (FDA) in May 2016 for use in PET imaging of biochemically recurrent prostate cancer. In May 2017, the European Medicines Agency (EMA) granted marketing authorisation for Axumin use in PET imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.
Blue Earth Diagnostics filed for marketing approval for Axumin with both the FDA and the EMA based on studies conducted on over 800 subjects in the USA, Italy and Norway.
Blue Earth Diagnostics has obtained Orphan Drug Designation (ODD) from the FDA and the EMA for the use of fluciclovine F 18 in the diagnosis of glioma, a form of brain cancer. Gliomas make up about 30% of all brain and central nervous system tumours and 80% of all malignant brain tumours. The symptoms, prognosis, and treatment of a malignant glioma depend on the person’s age, the exact type of tumour, and the location of the tumour – which often penetrates deep into the brain. Blue Earth Diagnostics plans to investigate the role of fluciclovine F 18 PET imaging in evaluating the spread of both high and low grade glioma within the brains of affected patients.
The company anticipates the development of follow-on indications for fluciclovine 18 in the diagnosis of other tumour types, as well as other applications in prostate cancer.