General Electric: GE Healthcare announces first patient dosed in phase III clinical trial for new dopamine transporter imaging radiopharmaceutical

GE Healthcare has today announced the first patient dosed in the Phase III clinical trial for a Positron Emission Tomography (PET) radiopharmaceutical imaging agent which aims to assist in the evaluation of adult patients with suspected Parkinsonian syndromes, support research and improve patient care. Already a global leader with DaTscan ([123I]-ioflupane), used in Single-Photon Emission Computed Tomography (SPECT) imaging across more than 40 countries worldwide, GE Healthcare is now planning to bolster its portfolio with two pipeline radiopharmaceuticals, one for PET and one for SPECT.

The multi-center Phase III clinical trial of a PET radiopharmaceutical is underway in France. In addition to offering a potentially shorter patient workflow, the clinical trial is comparing PET for striatal dopamine transporter visualization with DaTscan. PET technology offers higher spatial resolution than SPECT, which may result in a clearer image to aid visual interpretation and diagnosis. This PET radiopharmaceutical was originally developed by Zionexa, a French company specializing in innovative radiopharmaceuticals which was acquired by GE Healthcare’s Pharmaceutical Diagnostics business last year.

Speaking about the clinical trial, Professor Olivier Rascol, Professor of Clinical Pharmacology at Toulouse University Hospital, said: “We are excited to conduct this multi-center Phase III study which represents a significant milestone in the development of this radiopharmaceutical. Having a PET option for dopamine transporter imaging in patients with Parkinsonian syndromes could be highly relevant for an early differential diagnosis.”

A next stage clinical study for a SPECT dopamine transporter imaging agent will also be underway this year in the United States. Licensed from Boston-based brain imaging specialist, LikeMinds, it has the potential to reduce overall procedure time, to optimize imaging center workflow and help improve patient comfort. GE Healthcare has obtained exclusive global rights to the product.

Dr John Seibyl, Board Chairman and Distinguished Scientist, Institute for Neurodegenerative Disorders, New Haven, Connecticut, said: “This new SPECT agent may offer a faster imaging workflow which could provide more convenience for patients with suspected Parkinsonian syndromes and greater efficiency for the imaging clinic. It also holds promise in potentially making dopamine transporter imaging more accessible if approved.”

2021 marked ten years for GE Healthcare’s DaTscan in the U.S., used across the neurology community to aid clinical differentiation between conditions with nigrostriatal dopaminergic neurodegeneration, such as Parkinson’s disease, and those without, such as Essential Tremor. Imaging with DaTscan occurs between three and six hours after radiotracer injection.

Julia Casey, Molecular Imaging General Manager for GE Healthcare Pharmaceutical Diagnostics, said: “More than one million doses of DaTscan have already been used around the world in the clinical evaluation of Parkinsonian syndromes. Building on our leadership in this space, and to complement DaTscan, we are aiming to offer our customers, in both clinical and research settings, a wider choice of diagnostic tracers across PET and SPECT to suit all needs. We continue to invest in products that enable precision health and may help improve clinical outcomes.”

Globally, the number of people with Parkinson’s disease is estimated to double from 6.9 million in 2015 to 14.2 million in 20401. Early and accurate diagnosis helps patients, their families and care givers to identify appropriate resources and support as well as plan for the future and access treatment.

GE Healthcare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patients every second.