The companies said that they successfully produced Telix's PSMA-11-based prostate cancer imaging product, TLX591-CDx, using multi-Curie quantities of gallium-68, produced using ARTMS' quantum irradiation system (QIS) technology. TLX591-CDx is being developed for detection of prostate cancer using PET.
The production run resulted in six-hour stability of TLX591-CDx, and testing exceeded all relevant quality control standards for both low- (50 mCi and 100 mCi) and midlevel output (over 2,500 mCi) production runs of gallium-68.
The companies first announced the gallium-68 agreement last year. ARTMS said it will continue to pursue cyclotron-produced gallium-68 and will focus on optimizing the technology's production potential while also meeting regulatory requirements for using the radiotracer in radiopharmaceutical kits like TLX591-CDx.
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