Blue Earth, Collaborators to Present 18F-Fluciclovine Trial in Progress Data at SNO Conference

Blue Earth Diagnostics announced two presentations at the upcoming virtual 2021 Society of Neuro-Oncology (SNO) Conference on Brain Metastases on¹⁸F-fluciclovine, the company’s FDA-approved molecular imaging radiopharmaceutical for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

Blue Earth Diagnostics has two clinical studies underway to investigate the use of ¹⁸F-fluciclovine PET in the detection of recurrent brain metastases. The Phase 2 PURSUE trial is designed to establish image interpretation criteria for ¹⁸F-fluciclovine PET in detecting recurrent brain metastases. REVELATE is a Phase 3 study designed to evaluate its diagnostic performance in the detection of recurrent brain metastases in patients previously treated with radiation therapy.

¹⁸F-Fluciclovine PET is a novel diagnostic imaging radiopharmaceutical for PET imaging to visualize the increased amino transport that occurs in malignant tumors. It consists of a synthetic amino acid that is preferentially taken up by cancer cells compared with surrounding normal tissues and is labeled with the radioisotope ¹⁸F for PET imaging. ¹⁸F-Fluciclovine is under investigation by Blue Earth Diagnostics for potential use for the detection of recurrent brain metastases in adult patients who have previously undergone radiation therapy. ¹⁸F-Fluciclovine was invented at Emory University, in Atlanta, Ga., with much of the fundamental clinical development carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Blue Earth Diagnostics licensed ¹⁸F-fluciclovine from GE Healthcare and is investigating the molecule for other potential cancer indications, including in neuro-oncology.