Blue Earth Diagnostics Granted U.S., European Orphan Drug Designation for F-18 Fluciclovine

July 9, 2015 - Blue Earth Diagnostics Ltd (BED) announced it has received both U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) Orphan Drug Designation (ODD) for fluciclovine (¹⁸F) in the diagnosis of glioma. Fluciclovine is an investigational positron emission tomography (PET) radiopharmaceutical based on a synthetic amino acid, which appears to be preferentially taken up in a number of cancer indications, including in prostate cancer and brain tumors.

Gliomas make up about 30 percent of all brain and central nervous system tumors and 80 percent of all malignant brain tumors. The symptoms, prognosis, and treatment of a malignant glioma depend on the person's age, the exact type of tumor and the location of the tumour - which often penetrates deep into the brain. PET scan pictures show biological function and are complimentary with computed tomography (CT) scans and magnetic resonance imaging (MRI). Blue Earth Diagnostics plans to investigate the role of fluciclovine (¹⁸F) PET in evaluating the spread of both high and low grade glioma within the brains of affected patients.

Jeffrey Olson, M.D., neurosurgeon at Emory University, Atlanta, commented, "Although diagnosis of tumors of the brain with standard surgical, histologic and imaging techniques - such as CT and MRI - is accurate and well established, definitive staging and management of these diseases later in their course is in need of improvement. Imaging based on alternative mechanisms, such as PET with fluciclovine, offer the possibility of accurate diagnosis with the possibility of faster evaluation of therapeutic response. The addition of novel PET data to MRI, for example, may give treating physicians the confidence to continue treatment or justification to move on to an alternative therapy."

For more information: www.blueearthdiagnostics.com