Telix Pharmaceuticals Ltd（TLX）のニュースとイベントTLXTelix Pharmaceuticals Ltd

Telix Pharmaceuticals Doses First Patient with TLX250-Tx in LUTEON Study

Telix Pharmaceuticals announced that the first patient has been dosed with TLX250-Tx in the LUTEON study, the first radiopharmaceutical therapy to enter Phase 3 development for ccRCC. LUTEON is a randomized, prospective, open label, multi-center study evaluating a CAIX-targeting radionuclide therapy in patients with relapsed or recurrent ccRCC.

Telix Pharmaceuticals Doses First Patients in OPTIMAL-e Trial

Telix Pharmaceuticals announced that the first patients have been dosed with TLX597-Tx in the OPTIMAL-e trial, led by Professor Louise Emmett for patients with metastatic hormone-sensitive prostate cancer at St Vincent's Hospital in Sydney, Australia.

Telix Pharmaceuticals Successfully Advances TLX591-Tx Trial with FDA Meeting

Telix Pharmaceuticals announced the successful outcome of a Type B meeting with the FDA to review the Part 1 safety and dosimetry data and Part 2 protocol design of the ProstACT Global Phase 3 trial of its therapeutic candidate TLX591-Tx in metastatic castration resistant prostate cancer. The FDA has confirmed that the safety data from Part 1 of the study is sufficient to enable progression of Part 2 of ProstACT Global into the U.S. in which TLX591-Tx is administered in two doses, 14 days apart, in combination with one of three randomized standard of care therapies: abiraterone, enzalutamide or docetaxel. The FDA and Telix also achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan. The result is a consistent framework for study execution as enrollment continues internationally and expands into the U.S. Initiation of Part 2 in the U.S. remains subject to the FDA's review of an investigational new drug, or IND, amendment. The IND amendment will also be aligned with a pending regulatory submission to initiate the ProstACT Global study in Europe. The trial continues to enroll patients in regions where Part 2 is approved.