Telix to Supply Bayer with Illuccix® for Global Phase III Prostate Cancer Study
Melbourne (Australia) | 8 May 2023
Telix today announces that it has entered into an agreement with Bayer AG (Bayer) to supply Illuccix® (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection) for the Phase III ARASTEP study (ClinicalTrials.gov Identifier: NCT05794906). This global study is investigating the efficacy of Bayer’s androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT at baseline.
The study will enrol up to 750 patients across various sites such as in Europe, Japan and the United States. The more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans.
Telix Chief Medical Officer, Dr Colin Hayward stated, “We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix’s unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool.”
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 For regulatory reasons, Telix refers to its 68 Ga-PSMA-11 kit as Illuccix in markets where it has received regulatory approval, and TLX591-CDx when referring to its use in both approved and unapproved markets. Registrations vary country to country. Always refer to local labelling.
 Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography.