Blue Earth Diagnostics Ltd (BED), a private diagnostics company, announced that both US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted Orphan Drug designation to its fluciclovine (18F) in the diagnosis of glioma.
Fluciclovine (18F) 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 tumours.
Gliomas make up about 30 per cent of all brain and central nervous system tumours and 80 per cent 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. 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.
Jonathan Allis, chief executive officer of Blue Earth Diagnostics, said “We are pleased to receive Orphan Drug designations for fluciclovine (18F) in the diagnosis of glioma from two of the leading regulatory agencies in the world. As well as occurring in adults, malignant gliomas are the most common type of primary brain tumour in children and are associated with disproportionate cancer-related morbidity and mortality. Published data suggests that we may provide treating neurologists with additional information enabling identification of the extent of malignant infiltration of brain tissue, potentially permitting more effective treatment.”
Dr. Jeffrey Olson, neurosurgeon at Emory University, Atlanta, said
“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.”
Orphan Drug designation is a status granted to drugs or biological products that treat rare diseases or conditions. The designation qualifies the sponsor of the drug for various development incentives including a period of marketing exclusivity upon marketing approval for the designated indication, potential tax credits and the waiver of certain fees.