Recruitment Spotlight: Phase 3 Clinical Trial of Novel Prostate Cancer Radiopharmaceutical Now Active in Miami
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) announces that the Biogenix Molecular Research Center in Miami is now recruiting and dosing patients in the ProstACT Global Phase 3 trial of TLX591 for advanced prostate cancer. The center has successfully administered two doses of TLX591 to a local patient and continues recruitment in the Miami area as part of a wider U.S. rollout.
The trial investigates TLX591 as first-line and second-line therapy in metastatic castration resistant prostate cancer (mCRPC) in combination with standard of care. It features a patient-friendly dosing regimen of two doses 14 days apart and integrates with real-world standards of care including abiraterone, enzalutamide, or docetaxel chemotherapy.
ProstACT Global is the first trial to combine a PSMA-targeted radio antibody-drug conjugate (rADC) therapy with androgen receptor pathway inhibition and docetaxel sensitization, differentiating it from commercially available PSMA-targeted monotherapies and other radioligand therapies.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) annuncia che il Biogenix Molecular Research Center di Miami sta ora reclutando e somministrando trattamenti a pazienti nel ProstACT Global Phase 3 trial di TLX591 per il cancro alla prostata avanzato. Il centro ha somministrato con successo due dosi di TLX591 a un paziente locale e continua il reclutamento nella zona di Miami come parte di un più ampio lancio negli Stati Uniti.
Lo studio esamina TLX591 come terapia di prima e seconda linea nel cancro alla prostata resistente alla castrazione metastatica (mCRPC) in combinazione con le terapie standard. Presenta un regime di dosaggio amichevole per i pazienti, con due dosi a 14 giorni di distanza, e si integra con gli standard di cura del mondo reale, inclusi abiraterone, enzalutamide o chemioterapia con docetaxel.
ProstACT Global è il primo studio a combinare una terapia con coniugati di farmaci radioimmunologici mirati al PSMA (rADC) con l'inibizione della via del recettore androgenico e la sensibilizzazione al docetaxel, differenziandosi dalle monoterapie mirate al PSMA disponibili in commercio e da altre terapie con radioligandi.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) anuncia que el Biogenix Molecular Research Center en Miami está reclutando y dosificando pacientes en el ProstACT Global Phase 3 trial de TLX591 para el cáncer de próstata avanzado. El centro ha administrado con éxito dos dosis de TLX591 a un paciente local y continúa el reclutamiento en el área de Miami como parte de un lanzamiento más amplio en EE. UU.
El ensayo investiga TLX591 como terapia de primera y segunda línea en cáncer de próstata resistente a la castración metastásico (mCRPC) en combinación con el estándar de atención. Presenta un régimen de dosificación amigable para los pacientes, con dos dosis separadas por 14 días, e integra los estándares de atención del mundo real, incluidos abiraterona, enzalutamida o quimioterapia con docetaxel.
ProstACT Global es el primer ensayo en combinar una terapia de conjugado de anticuerpo radioactivo dirigido a PSMA (rADC) con la inhibición de la vía del receptor de andrógenos y la sensibilización al docetaxel, diferenciándose de las monoterapias dirigidas a PSMA disponibles comercialmente y de otras terapias con radioligandos.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX)는 마이애미의 Biogenix Molecular Research Center가 이제 ProstACT Global Phase 3 trial에서 진행 중인 전립선암 환자를 모집하고 치료하고 있다고 발표했습니다. 이 센터는 현지 환자에게 TLX591의 두 번의 용량을 성공적으로 투여했으며, 미국 전역에서의 더 넓은 출시의 일환으로 마이애미 지역에서 계속해서 환자를 모집하고 있습니다.
이 시험은 표준 치료와 병행하여 전이성 거세 저항성 전립선암 (mCRPC)에 대한 1차 및 2차 치료제로서 TLX591을 조사합니다. 환자 친화적인 투여 요법을 특징으로 하며, 14일 간격으로 두 번의 용량을 포함하고, abiraterone, enzalutamide 또는 docetaxel 화학요법과 같은 실제 치료 표준과 통합됩니다.
ProstACT Global은 PSMA 표적 방사성 항체-약물 결합체(rADC) 치료를 안드로겐 수용체 경로 억제 및 docetaxel 민감화와 결합한 첫 번째 시험으로, 상업적으로 이용 가능한 PSMA 표적 단일 요법 및 기타 방사성 리간드 치료와 차별화됩니다.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) annonce que le Biogenix Molecular Research Center à Miami recrute et traite désormais des patients dans l'essai ProstACT Global Phase 3 trial de TLX591 pour le cancer de la prostate avancé. Le centre a administré avec succès deux doses de TLX591 à un patient local et continue le recrutement dans la région de Miami dans le cadre d'un déploiement plus large aux États-Unis.
L'essai examine TLX591 comme thérapie de première et de deuxième ligne dans le cadre du cancer de la prostate résistant à la castration métastatique (mCRPC) en combinaison avec les traitements standards. Il présente un schéma posologique convivial pour les patients, avec deux doses espacées de 14 jours, et s'intègre aux normes de soins du monde réel, y compris l'abiraterone, l'enzalutamide ou la chimiothérapie par docétaxel.
ProstACT Global est le premier essai à combiner une thérapie par conjugués anticorps-médicaments radioactifs ciblant le PSMA (rADC) avec l'inhibition de la voie des récepteurs aux androgènes et la sensibilisation au docétaxel, se différenciant ainsi des monothérapies ciblant le PSMA disponibles dans le commerce et d'autres thérapies par radioligands.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) gibt bekannt, dass das Biogenix Molecular Research Center in Miami jetzt Patienten im ProstACT Global Phase 3 trial von TLX591 für fortgeschrittenen Prostatakrebs rekrutiert und behandelt. Das Zentrum hat erfolgreich zwei Dosen von TLX591 an einen lokalen Patienten verabreicht und setzt die Rekrutierung in der Umgebung von Miami als Teil einer breiteren Einführung in den USA fort.
Die Studie untersucht TLX591 als Erst- und Zweitlinientherapie bei metastasiertem kastrationsresistentem Prostatakrebs (mCRPC) in Kombination mit der Standardtherapie. Sie bietet ein patientenfreundliches Dosierungsschema mit zwei Dosen im Abstand von 14 Tagen und integriert sich in die realen Behandlungsstandards, einschließlich Abirateron, Enzalutamid oder Chemotherapie mit Docetaxel.
ProstACT Global ist die erste Studie, die eine PSMA-zielgerichtete radioimmunologische Therapie (rADC) mit der Hemmung des Androgenrezeptorwegs und der Sensibilisierung gegenüber Docetaxel kombiniert und sich damit von kommerziell verfügbaren PSMA-zielgerichteten Monotherapien und anderen Radioligandentherapien unterscheidet.
- Phase 3 trial of TLX591 for advanced prostate cancer now recruiting patients in Miami
- Patient-friendly dosing regimen of only two doses, 14 days apart
- First trial to combine PSMA-targeted radio antibody-drug conjugate therapy with standard of care
- Previous Phase 1 and 2 trials showed encouraging results
- None.
Insights
Telix Pharmaceuticals' announcement regarding the activation of its Phase 3 ProstACT Global trial for TLX591 in Miami represents a significant clinical milestone with material implications for investors tracking the radiopharmaceutical oncology space.
The trial's innovative design merits particular attention from a clinical development perspective. By combining a PSMA-targeted radio antibody-drug conjugate (rADC) with standard-of-care treatments, Telix is pursuing a differentiated approach compared to competitors like Novartis's Pluvicto (177Lu-PSMA-617), which utilizes a small molecule peptide carrier. The antibody-based approach potentially offers advantages in tumor targeting specificity, retention time, and radiation delivery efficiency – factors that could translate to improved efficacy and competitive positioning if successful.
The streamlined dosing regimen (just two doses administered 14 days apart) represents a patient-friendly approach that could significantly improve adoption and compliance compared to more intensive treatment protocols. This could be a meaningful commercial differentiator in a market where patient experience increasingly influences treatment selection and reimbursement decisions.
The prostate cancer therapeutic landscape represents a $12+ billion market with substantial growth potential. As the most commonly diagnosed cancer in U.S. men, the addressable patient population for advanced prostate cancer treatments remains substantial despite increasing competition. The metastatic castration-resistant prostate cancer (mCRPC) segment that Telix is targeting represents patients with high unmet need and treatment options after progression on initial therapies.
This Phase 3 trial progression suggests Telix is approximately 2-3 years from potential regulatory submission, assuming positive results. The company's execution against clinical development milestones is particularly important as it builds on its commercial foundation established with Illuccix, its PSMA-PET imaging agent. Success with TLX591 would transform Telix from primarily a diagnostic company to a fully integrated theranostic player with both diagnostic and therapeutic radiopharmaceutical products.
Investors should monitor patient enrollment rates and any interim data releases, as these will provide insights into both the timeline to potential commercialization and early efficacy signals that could impact valuation well before final trial results.
MELBOURNE, Australia and INDIANAPOLIS, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) announces that the Biogenix Molecular Research Center in Miami, FL, is recruiting and dosing patients in the ProstACT Global Phase 3 trial1 of TLX591 for patients with advanced prostate cancer, as part of a wider United States (U.S.) roll-out.
ProstACT Global is trialling a promising new treatment option for prostate cancer, which is the most commonly diagnosed cancer and the second leading cause of cancer-related death for U.S. men. This month, Biogenix Molecular Research Center successfully administered two doses of TLX591, 14 days apart, to a local Miami-based patient, and continues to recruit eligible patients in the Miami area.
The trial – sponsored by Telix – will investigate and confirm the benefits and risks associated with TLX591 as first-line and second-line therapy in metastatic castration resistant prostate cancer (mCRPC) in combination with standard of care. The innovative trial design is differentiated by a patient-friendly dosing regimen (two doses, 14 days apart) and integrates with real-world standards of care (abiraterone, enzalutamide, or docetaxel chemotherapy), reflective of Telix’s continued innovation in prostate cancer care and commitment to patient outcomes.
ProstACT Global is the first trial to combine the synergistic effects of prostate-specific membrane antigen- (PSMA)- targeted radio antibody-drug conjugate (rADC) therapy in combination with androgen receptor pathway inhibition (ARPI), and docetaxel sensitization. This approach differs from commercially available PSMA-targeted monotherapy and previous or active studies being conducted with small molecule peptide carrier radioligand therapies (RLTs).
Dr. Frankis Almaguel, Director of the Molecular Imaging and Therapeutics Nuclear Oncology Program at Biogenix Molecular Research Center in Miami, FL, and a Principal Investigator on the ProstACT Global trial, stated, “The team at Biogenix is pleased to be dosing patients on this ground-breaking study of Telix’s lead investigational rADC, TLX591, which has delivered such encouraging results in previous Phase 1 and 2 trials. There remains significant unmet need for effective combination treatment intensification in this first- and second-line mCRPC patient population, to improve long-term outcomes without sacrificing quality of life.”
Dr. David N. Cade, Group Chief Medical Officer, Telix, added, “We are very pleased to see Biogenix Molecular Research Center participating in Telix’s international ProstACT Global trial. This study builds on an already extensive data set for TLX591, and we believe it will demonstrate the benefits of an antibody-based approach in combination with real world standards of care.”
About TLX591
TLX591 (lutetium (177Lu) rosopatamab tetraxetan) is Telix’s lead rADC candidate, which comprises a therapeutic isotope (177Lu) attached to an antibody called rosopatamab. TLX591 uses the antibody as both a homing device and a carrier to deliver therapeutic radiation to PSMA.
TLX591 shows high PSMA tumor antigen specificity with low rates of off-target organ exposure, while a simple two-dose regimen, administered over 14 days, offers patient convenience versus commercially available PSMA-targeted RLT therapy of up to six cycles over 30 weeks. There is an unmet need for products that offer lower radiation exposure compared to existing RLTs for prostate cancer2. The PSMA-targeted rADC approach demonstrates different targeting and pharmacology to that observed in certain anti-PSMA small peptide RLT molecules. In contrast to these therapies3, collective long-term follow-up of patients administered with TLX591 has not observed significant acute or delayed kidney toxicity, as the agent is cleared through the liver, instead of the kidneys4. Due to its large molecular weight, TLX591 also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs5.
The ProstACT Global trial design consists of an international, multicenter trial in two parts: Part 1, safety and dosimetry run-in with 30 patients; and Part 2, 2:1 randomized global expansion with an overall target enrolment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET6 imaging agent (such as Illuccix®) following prior treatment with an ARPI.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).
Telix’s prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)7, by the Australian Therapeutic Goods Administration (TGA)8, by Health Canada9 , by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)10 and in multiple countries within the European Economic Area (EEA)11. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM12. TLX591 has not received a marketing authorization in any jurisdiction and is for investigational use only.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
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1 ClinicalTrials.gov ID: NCT06520345.
2 152 mCi cumulative radiation exposure with TLX591 compared with up to 1200 mCi with current approved RLT, based on prescribing information.
3 Steinhelfer et al. JNM. 2024.
4 Tagawa et al. Cancer. 2019.
5 Pepin et al. Pract Radiat Oncol. 2025.
6 Positron emission tomography.
7 Telix ASX disclosure 20 December 2021.
8 Telix ASX disclosure 2 November 2021.
9 Telix ASX disclosure 14 October 2022.
10 Telix ASX disclosure 13 February 2025.
11 Denmark, Luxembourg, Malta, and Norway at time of release.
12 Telix ASX disclosure 17 January 2025.
FAQ
What is the purpose of Telix's ProstACT Global Phase 3 trial for TLX591?
How is TLX591's dosing regimen different from other prostate cancer treatments?
What makes Telix's TLX591 different from other PSMA-targeted therapies?
Where is Telix Pharmaceuticals (TLX) conducting the ProstACT Global Phase 3 trial?
What results has TLX shown in previous clinical trials?
