GE’s Flutemetamol Gets Positive Phase II Data

GE Healthcare achieved positive results from its multi-center Phase II study of flutemetamol, a positron emission tomography (PET) imaging agent for brain imaging. A Phase III trial program is also currently underway.

The study investigated the efficacy of flutemetamol in differentiating between patients with clinically probable Alzheimer’s disease (AD) and cognitively intact healthy volunteers (HVs). Five independent image readers, each blinded to the patient diagnosis, separately decided if each subject’s image was normal or abnormal. The accuracy of image assessments was determined by comparing them to the subjects’ diagnoses.

The flutemetamol Phase III trial program is a series of multi-center studies that include patients who consent to brain biopsy or to post-mortem assays to determine the level of association between imaging detection and histopathology findings. The trials have begun recruitment and imaging of patients at multiple sites in the U.S. and Europe.