Telix doses first affected person in TLX591-Px prostate imaging examine
Telix Prescription drugs has dosed the primary affected person in its pivotal Part III registrational examine of TLX591-Px (Illuccix, Equipment for the Preparation of 68Ga-PSMA-11), concentrating on prostate most cancers imaging in Japanese sufferers.
The dosing befell at Shonan Kamakura Common Hospital in Kamakura, Japan. The examine goals to additional consider the protection and efficacy of the detection on this inhabitants.
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Extra data
The Illuccix Japan examine is an open-label, multicenter, potential part III examine evaluating 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) in biochemically relapsed prostate most cancers sufferers after prior radical prostatectomy.
As much as 105 Japanese males shall be enrolled throughout 11 websites, with information meant to assist a future advertising authorization submission for TLX591-Px within the nation.
The first goal is to check 68Ga-PSMA-11 PET/CT sensitivity with standard imaging strategies, together with CT and bone scintigraphy, in detecting metastatic lesions.
Secondary aims embody assessing diagnostic efficiency for each distant and localized lesions, evaluating tolerability and security, and figuring out how this imaging strategy might affect medical administration choices.
Dr. David Cade, Chief Medical Officer of Telix Group, stated: “PSMA-PET imaging has essentially modified the way in which we detect and deal with prostate most cancers, delivering larger accuracy and confidence in remedy planning in comparison with standard imaging. But entry stays restricted in a lot of Japan, the place 68Ga-PSMA-11 has not been absolutely validated within the native medical setting or in any respect levels of the illness.
“This milestone, along with Telix’s present compassionate use providing to handle the unmet wants of sufferers, brings us considerably nearer to rising entry to gallium-based PSMA-PET and bettering outcomes for males with prostate most cancers in Japan.”
TLX591-Px (Illuccix) is the corporate’s first-generation PSMA-PET imaging agent and has obtained approval in a number of markets worldwide, however stays below investigation solely in Japan.
In June 2025, Telix launched a PET radiochemical resolution, AlFluor, primarily based on ¹⁸F aluminum fluoride (AlF).
