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.
