First Patients Dosed in OPTIMAL-e Trial for Earlier Stage Prostate Cancer
First patients dosed in OPTIMAL-e [1] Phase 2 study evaluating TLX597-Tx for metastatic hormone-sensitive prostate cancer at St Vincent's Hospital Sydney. OPTIMAL-e will evaluate TLX597-Tx in earlier prostate cancer treatment setting, building on the OPTIMAL-PSMA [2] study which recently completed patient enrollment. TLX597-Tx is Telix's next generation PSMA [3] -targeting small molecule radioligand therapy candidate designed to improve efficacy and quality of life in earlier-stage prostate cancer. MELBOURNE, Australia and INDIANAPOLIS , July 16, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") and St Vincent's Hospital today announced that the first patients have been dosed with TLX597-Tx ( 177 Lu-DOTA-HYNIC-panPSMA) in the OPTIMAL-e trial, led by Professor Louise Emmett for patients with metastatic hormone-sensitive prostate cancer (mHSPC) at St Vincent's Hospital in Sydney, Australia. OPTIMAL-e is a single-arm, open-label trial, evaluating adaptive-dosed TLX597-Tx in combination with androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) in men with mHSPC. The study will evaluate the impact of TLX597-Tx on PSA [4] response rate in an earlier treatment setting, assessing its potential to improve both the depth and durability of PSA response, while further evaluating the safety of dose intensification. TLX597-Tx is a highly-targeted next generation small molecule RLT [5] designed to improve efficacy and quality of life in earlier-stage metastatic prostate cancer. It has demonstrated a favorable biodistribution and dosimetry profile in prior studies including OPTIMAL-PSMA [6] , suggesting low exposure to salivary glands and the kidneys, the healthy organs of concern with PSMA RLT, and high uptake in PSMA-expressing tumors. Louise Emmett, MD, Director of Theranostics and Nuclear Medicine, St. Vincent's Hospital, and Lead Investigator of the OPTIMAL-e study, said, "I am excited to lead the OPTIMAL-e trial, which is evaluating an adaptive treatment approach designed to tailor therapy to each patient's response. By using PSMA-PET [7] imaging and PSA measurements to monitor disease burden, treatment can be continued when the PSMA target persists, and paused when there is a significant reduction in tumor burden. This individualized strategy aims to maintain disease control while minimizing unnecessary treatment exposure, with the potential to keep patients in a low-volume disease state for longer and support quality of life. The findings from OPTIMAL-e may help shape future treatment strategies and advance precision medicine for men living with prostate cancer." David N. Cade, MD, Group Chief Medical Officer, Telix, said, "The initiation of OPTIMAL-e marks an important evolution of PSMA-targeted radioligand therapy for earlier metastatic prostate cancer, where maintaining quality of life is paramount. While the currently approved radioligand therapy has demonstrated a modest improvement in overall survival in advanced-stage disease, we believe earlier intervention may offer the potential to further improve outcomes and prolong quality of life for patients." TLX597-Tx has not received marketing authorization in any jurisdiction. About OPTIMAL-e OPTIMAL-e is a Phase 2, non-randomized pilot study evaluating adaptive-dosed TLX597-Tx ( 177 Lu-DOTA-HYNIC-panPSMA) in combination with ADT and an ARPI in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Adaptive dosing of 177 -Lu-PSMA is the concept of only treating if the PSMA target is persistent, while pausing treatment if there is a marked reduction in the tumor target, with re-treatment at first confirmed PSA rise (once the target has returned). The study is investigating whether intensified, response-adapted PSMA-targeted radioligand therapy can deepen responses, improve disease control and enable treatment pauses for selected patients based on PSMA-PET imaging and PSA outcomes. TLX597-Tx is being developed alongside TLX591-Tx (lutetium-177 ( 177 Lu) rosopatamab tetraxetan), Telix's lead antibody-based prostate cancer therapy candidate, currently the subject of the Phase 3 ProstACT Global [8] trial in mCRPC [9] , which is actively dosing patients in jurisdictions with regulatory approval. TLX591-Tx and TLX597-Tx exhibit complementary modes-of-action, suggesting the potential for distinct applications in mCRPC and mHSPC settings as part of Telix's portfolio approach to treating prostate cancer. About Telix Pharmaceuticals Limited Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix® (kit for the preparation of gallium-68 gozetotide injection), Telix's next-generation PSMA-PET imaging agent approved by the U.S. FDA. The Company's late-stage therapeutic pipeline includes three assets in pivotal-stage trials - TLX591-Tx (lutetium-177 ( 177 Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx ( 131 I-iodofalan) in recurrent glioblastoma, TLX250-Tx ( 177 Lu-girentuximab) in kidney cancer, complemented by a deep pipeline of next generation assets. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn , X and Facebook . Telix Contacts Investor Relations Annie Kasparian annie.kasparian@telixpharma.com Charlene Jaw charlene.jaw@telixpharma.com Media Eliza Schleifstein 917.763.8106 (Mobile) Eliza@schleifsteinpr.com Legal Notices Cautionary Statement Regarding Forward-Looking Statements. 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. 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In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enroll 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 commercialization 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; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix's business, including as a result of war or other geopolitical conflicts; 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. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or TM symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved. [1] Australian New Zealand Clinical Trials Registry ID: ACTRN12626000034336 . [2] Australian New Zealand Clinical Trials Registry ID: ACTRN12625000971437 . [3] Prostate-specific membrane antigen. [4] Prostate-specific antigen. [5] Radioligand therapy. [6] Telix media release April 30, 2026. [7] Imaging of prostate-specific membrane antigen with positron emission tomography. [8] ClinicalTrials.gov ID: NCT06520345 . [9] Metastatic castration-resistant prostate cancer.
2026-07-15 20:30:00
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