Telix Pharmaceuticals (ASX:TLX) and partner ARTMS have announced they have successfully produced Telix's prostate cancer imaging product, TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11).
The product was manufactured using multi-Curie quantities of cyclotron-produced Gallium-68 (68Ga) via ARTMS’ proprietary Quantum Irradiation System (QIS) solid target system.
The companies' said testing demonstrated six-hour stability of TLX591-CDx. It is a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET).
Testing exceeded all relevant quality control standards for both low and mid-level output 68Ga production runs.
The 'cold kit' format of TLX591-CDx enables rapid radiolabelling at room temperature with high radiochemical purity and production consistency, ideally suited for the radiopharmacy setting.
ARTMS CEO Charles S. Conroy said, “This collaboration and successful testing represents a significant step forward for the diagnosis of prostate cancer globally. The combination of Telix’s user friendly, high quality PSMA-11 kit along with robust production of 68Ga using our solid targetry approach moves us closer to having a PET diagnostic agent on demand for clinicians. Our goal at ARTMS is to ensure that the 68Ga supply is able to meet the substantial projected clinical demand for thisisotope.”
Telix US President, Dr Bernard Lambert, added, “When the Telix-ARTMS collaboration was announced in April 2020, we were confident that ARTMS’ proprietary technology to produce 68Ga from specialized solid 68Zn targets using low-energy cyclotrons would be valuable to the Molecular Imaging and Oncology community.
"ARTMS’ work represents a significant development in how 68Ga is able to be supplied to the market for large-scale production and, as a result, will contribute to the reliability of access to all men living with prostate cancer who require advanced prostate imaging. This outcome is a testament to both the ARTMS technology and Telix’s proprietary formulation of PSMA-11”