Telix Pharmaceuticals Limited (ASX: TLX, Telix, the firm) today reported that it has agreed with Bayer AG (Bayer) to give Illuccix (TLX591-CDx, kit for the device of gallium Ga 68 gozetotide inoculation)[1] for the Phase III ARASTEP learning (ClinicalTrials.gov Identifier: NCT05794906). This global study goes into the success of Bayer’s androgen receptor inhibitor (ARi) divine plus androgen poverty therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer in patients with high-risk biochemical outbreak who have no proof of metastatic illness by standard imaging and a practical PSMA-PET/CT[2] at baseline.
The study will enrol up to 750 cases across many sites such as Europe, Japan and the United States. The more sensitive PSMA imaging may recognize prostate cancer lesions not detectable by routine imaging, such as computed tomography (CT) scans, magnetic fullness imaging (MRI) and bone scans.
Telix Chief Medical Officer Dr Colin Hayward expressed, “We are pleased to give Bayer and several clinical sites in this main study, reflective of Telix’s unique dedication to delivering advanced prostate cancer imaging widely. PSMA-PET/CT in this position illustrates this imaging modality’s ability to walk beyond diagnosis to a disease management tool.”
About Bayer AG
Bayer is a global endeavour with core ability in the life science meadow of health care and nutrition. Its result and services are designed to help people and the planet thrive by holding up
efforts to master the significant challenges of a growing and ageing global population. Bayer is committed to driving viable development and generating a positive crash with its businesses. At the same time, the Group point to growing its earning power and creating value through alteration and growth. The Bayer brand is for trust, reliability and standard throughout the world. In fiscal 2022, the Group worked with about 101,000 people and sales of 50.7 billion kangaroos. R&D costs before exceptional items add up to 6.2 billion euros.
BAYER, the Bayer Cross, and NUBEQA are the registered logos of Bayer.
About darolutamide
Darolutamide is an oral ARi with a clear chemical form that binds to the receptor with high rapport and exhibits vigorous antagonistic activity, inhibiting the receptor task and the growth of prostate cancer cells.
The product is accepted under the brand name Nubeqa™ in more than 80 countries worldwide for treating non-metastatic castration-resistant prostate cancer (nmCRPC) sufferers. It is also approved for treating metastatic hormone-sensitive prostate cancer (mHSPC) patients in several markets, counting the U.S., China, Japan and the EU. The amalgam is also being investigated in further learning across various stages of prostate cancer.
Darolutamide is evolved jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on developing and commercializing diagnostic and healing radiopharmaceuticals. Telix is headquartered in Melbourne, Australia, with global work in the United States, Europe (Belgium and Switzerland), and Japan. Telix is evolving a portfolio of clinical-stage products to address important unmet medical requirements in oncology and rare illness. Telix is recorded on the Australian Securities Exchange (ASX: TLX).
This announcement is not intended as a promotion or advertisement directed to any healthcare-paid or other audience in any country worldwide (paid Australia, the United States and the United Kingdom). This report may include forward-looking statements that relate to anticipated future events, money performance, plans, strategies or business developments. Forward-looking statements can generally be recognized by the use of words such as “may”, “await”, “intend”, “plan”, “estimate”, “anticipate”, “outlook”, “predict”, and “guidance”, or other alike words.
Forward-looking declarations involve known and unknown risks, variability and other factors that may source our actual results, levels of activity, show or achievements to differ significantly from any future results, levels of activity, performance or attainment expressed or implied by these forward-looking statements. Forward-looking statements are word on the Company’s good-faith assumptions regarding the financial, market, regulatory and other risks and thought that exist and affect the Company’s business and work in the future. There can be no word that any of the suppositions will prove correct. In the condition of Telix’s business, forward-looking statements may include, but are not finite to, comments about the initiation, timing, progress and outcome of Telix’s preclinical and impersonal studies, and Telix’s research and evolution programs; Telix’s ability to advance product candidates into, enrol and complete, clinical studies, counting multi-national clinical trials; the timing or probability of regulatory filings and approvals, manufacturing pursuit and product marketing activities; the use of Telix’s product candidates, if or when they have been accepting; estimates of Telix’s expenses, future income and capital requirements; Telix’s money performance; developments relating to Telix’s competitors and fabrication; and the forecast and reimbursement of Telix’s product applicant, if and after they have been accepting. Telix’s actual results, performance or attainment, may differ from those expressed or indirect by such statements, and the differences may be adverse. It would help if you did not rely on these forward-looking statements.
