Pharma Focus Asia

ARTMS and Terix Pharmaceuticals Announce Successful Manufacture of PSMA-11 Using Cyclotron 68Ga from Solid Target

Monday, January 18, 2021

RTMS Inc.and Terix Pharmaceuticals Limited Terix's TLX591 prostate cancer imaging product using multiple curry units of gallium-68 ( 68 Ga) manufactured on a cyclotron through a proprietary Quantum Irradiation System (QIS®) solid-state targeting system. -Announces the successful production of CDx ( 68 Ga-PSMA-11 Preparation Kit) 1 .

Studies have shown excellent stability over 6 hours of TLX591-CDx for use in prostate cancer imaging with positron emission tomography (PET) as a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) . It was. Test results exceeded all relevant quality control standards for 68 Ga production runs at both low (50 mCi and 100 mCi) and medium (> 2500 mCi) radioactivity . The TLX591-CDx "cold kit" format offers high radiochemical purity and manufacturing consistency for rapid radiolabeling at room temperature, making it ideal for the environment of the radiopharmaceutical sector.

Charles S. Conroy, CEO of ARTMS, said: “This collaboration and successful testing is an important step forward in the diagnosis of prostate cancer worldwide. Using Terix's easy-to-use, high-quality PSMA-11 kit and our solid-state targeting approach, we have a stable 68 Ga. Combined with the ability to produce, clinicians are moving towards getting on-demand PET diagnostics. The goal of ARTMS is that the supply of 68 Ga is expected to be large for this isotope. To ensure that the clinical needs are met. "

Dr. Bernard Lambert, President of Telix USA, adds: "When we announced the collaboration between Terix and ARTMS in April 2020, ARTMS's proprietary technology to produce 68 Ga from a special solid 68 Zn target using a low energy cyclotron would be beneficial to the molecular imaging and oncology community. We were convinced that ARTMS's work was a major advance in how to bring 68 Ga to the market for large-scale production , resulting in prostate cancer and advanced prostate. It will contribute to reliable utilization for all male patients in need of imaging. This achievement demonstrates the effectiveness of ARTMS technology and Terix's proprietary PSMA-11 formulation. . "

ARTMS will continue to focus on optimizing manufacturing potential and meeting regulatory requirements for use in radiopharmaceutical kits such as the TLX591-CDx as it develops the 68 Ga manufactured in the cyclotron .

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