October 16, 2019 — GE Healthcare and Theragnostics have entered into a global commercial partnership for a new prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging agent. Theragnostics will lead the development of the tracer, GalliProst, while GE Healthcare will lead all pre-approval commercial preparations and, as and when approval is received, all subsequent commercial and distribution activities.
Today, prostate cancer is the fourth largest cancer type, accounting for just over 1.2 million new cases and over 350,000 fatalities around the globe in 2018. The diagnostic workflow for detecting prostate cancer starts through a blood test or biopsy, after which patients are typically referred for PET/CT imaging so that radiologists can see their tumor, lymph nodes and any metastasis in order to decide the appropriate course of treatment. The ‘heatmap’ style image enabled by the new tracer shows the precise location and intensity of PSMA, which is expressed on the surface of prostate cancer cells.
Theragnostics has reported data from a phase two clinical study which met its primary and secondary endpoints, demonstrating that one third of newly diagnosed prostate cancer patients — and more than 50 percent of patients with biochemically recurrent disease — had their treatment plans modified as a result of a GalliProst scan. The change in patient management increased to 75 percent in a post-radical radiotherapy setting.
This marks the second agreement between Theragnostics and GE Healthcare, following an agreement in 2018 for a diagnostic tracer for imaging kidney function and scarring.