GE Healthcare and Theragnostics announce global commercial partnership for late stage PSMA diagnostic for prostate cancer

Chalfont St Giles, UK (STL.News) – GE Healthcare and Theragnostics have entered into a global commercial partnership for a new Prostate-Specific Membrane Antigen (PSMA) 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 over 50% 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% in a post-radical radiotherapy setting.

“We are excited to partner with Theragnostics on GalliProst to give vital insights into prostate cancer,” said Sanka Thiru, Global Product Leader, Molecular Imaging Oncology in GE Healthcare’s Pharmaceutical Diagnostics business.  “We believe that this partnership enables both parties to leverage each other’s key areas of expertise in order to accelerate the development of GalliProst and ultimately improve patient care.”

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Greg Mullen, CEO of Theragnostics added “This agreement is validation of the potential for our novel prostate cancer Gallium-68 (68Ga) diagnostic tracer, GalliProst which can benefit the treatment of prostate cancer patients around the globe.  We are very pleased to sign our second agreement with GE Healthcare following our agreement last year for a diagnostic tracer for imaging kidney function and scarring.”

Both GE Healthcare and Theragnostics will be attending the upcoming European Association of Nuclear Medicine 2019 Congress (EANM) in Barcelona from Saturday October 12-16.