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.
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You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.
The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.
This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.
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.
