# OPTIMAL-PSMA Trial of TLX597-Tx Next Generation RLT Presented at IPCS 2026 Highlighting Therapeutic Potential in Prostate Cancer - Link: https://www.thailand-business-news.com/pr-news/optimal-psma-trial-of-tlx597-tx-next-generation-rlt-presented-at-ipcs-2026-highlighting-therapeutic-potential-in-prostate-cancer - Published: 2026-04-30T04:00:00+07:00 - Author: PR Newswire | | ◦ TLX597-Tx is a PSMA^([1])-targeting small molecule radioligand therapy (RLT) candidate, designed to improve quality-of-life and efficacy in earlier-stage prostate cancer. ◦ OPTIMAL-PSMA^([2]) initial dosimetry data demonstrate low salivary gland and kidney uptake, supporting dose intensification. ◦ Telix is developing two distinct prostate therapeutic programs, tailored to disease stage and patient condition: TLX591-Tx radio antibody-drug conjugate (rADC) in combinations with standard of care (Phase 3 in mCRPC^([3])) and TLX597-Tx intended for earlier-stage mHSPC^([4]). ◦ **Webcast today:** Thursday, April 30, at 9:30 a.m. AEST (Wednesday, April 29, at 7:30 p.m. EDT). Register here: [https://s1.c-conf.com/diamondpass/10053985-675tre.html](https://s1.c-conf.com/diamondpass/10053985-675tre.html) MELBOURNE, Australia and INDIANAPOLIS, April 30, 2026 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces dosimetry results from the randomized Phase 2 OPTIMAL-PSMA trial of TLX597-Tx in metastatic castration- resistant prostate cancer (mCRPC), presented at the 2026 International Prostate Cancer Symposium (IPCS 2026) held in Lugano, Switzerland. These findings support TLX597-Tx’s potential to deliver a treatment that overcomes quality-of-life challenges that currently limit the clinical utility of existing RLTs in earlier-stage metastatic prostate cancer. TLX597-Tx (^(177)Lu-DOTA-HYNIC-panPSMA) is a novel PSMA-targeting small molecule RLT candidate with a highly favorable dosimetry profile. Significantly reduced radiation exposure to healthy organs, including the salivary glands and kidneys^([5]), may lower the incidence of xerostomia (dry mouth) and renal toxicity and support better tolerability for patients. This dosimetry profile combined with higher tumor uptake compared to existing PSMA RLTs may deliver a wider therapeutic window and enable dose intensification to maximize tumor control while preserving patient quality- of-life. OPTIMAL-PSMA is an open-label, multi-center, randomized, Phase 2 investigator-initiated trial (IIT) led by Professor Louise Emmett at St Vincent’s Hospital in Sydney, Australia. The study is evaluating the safety, dosimetry, and efficacy of an intensified dosing regimen of TLX597-Tx compared with a standard dose schedule in 120 men with advanced mCRPC, randomized on a 2:1 basis. The novel dose-intensification regimen delivers higher activity per cycle (8.5 GBq), delivered on day 1, day 3 and day 15, followed by 10-weekly dosing for three further cycles. The study aims to confirm that a dose intensified TLX597-Tx regimen will maximize the radiation dose to cancerous lesions when they are most vulnerable to damage and therefore improve overall response to treatment. Telix believes these dosimetry data support further evaluation of TLX597-Tx in earlier- stage disease and is initiating OPTIMAL-E, a Phase 2 study in androgen pathway-sensitive prostate cancer (mHSPC). Principal Investigator for OPTIMAL-PSMA, Professor Louise Emmett, commented, "The goal of OPTIMAL-PSMA is to identify a dose regimen for TLX597-Tx that leads to deeper and longer responses without increasing toxicity for men with metastatic prostate cancer. We look forward to starting the Phase 2 OPTIMAL-E trial soon." Dr. David N. Cade, Group Chief Medical Officer at Telix, added, "These encouraging dosimetry results from OPTIMAL-PSMA, combined with earlier exploratory work^([6]), are very promising and highlight TLX597-Tx’s potential to substantially increase the tumor dose while minimizing radiation to sensitive organs. For people living with earlier-stage metastatic disease, preserving quality-of-life alongside effective cancer control is mandatory. These findings support further study in mHSPC and reinforce Telix’s strategy to develop differentiated PSMA-targeting therapies, so clinicians may be able to tailor treatment choice to the patient’s disease stage and individual condition." 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^([7]) trial in mCRPC, which is actively dosing patients in jurisdictions with regulatory approval and recently reported data from a safety and dosimetry lead-in^([8]). 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. TLX591-Tx and TLX597-Tx have not received marketing authorization in any jurisdiction. To view the webcast slides, click [here](https://telixpharma.com/wp-content/uploads/2026/04/20260430_TLX597-Tx-Webinar_vFINAL.pdf). **About Telix Pharmaceuticals Limited ** Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe( Belgium and Switzerland) and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Visit [www.telixpharma.com](http://www.telixpharma.com/) for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (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](https://www.linkedin.com/company/telixpharma/), [X](https://x.com/TelixPharma) and [Facebook](https://www.facebook.com/TelixPharma). | **Telix Investor Relations (Global)** Ms. Kyahn Williamson SVP Investor Relations and Corporate Communications [kyahn.williamson@telixpharma.com](https://www.thailand-business-news.com/pr-news/kyahn.williamson@telixpharma.com) | **Telix Investor Relations (Australia)** Ms. Charlene Jaw Associate Director Investor Relations [charlene.jaw@telixpharma.com](https://www.thailand-business-news.com/pr-news/charlene.jaw@telixpharma.com) | **Telix Investor Relations (U.S.) **  Ms. Annie Kasparian   Director Investor Relations and Corporate Communications   [annie.kasparian@telixpharma.com](https://www.thailand-business-news.com/pr-news/annie.kasparian@telixpharma.com)  | | | | | | **Media Contact** Eliza Schleifstein 917.763.8106 (Mobile) [Eliza@schleifsteinpr.com](https://www.thailand-business-news.com/pr-news/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. 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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 ™ 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]) Prostate-specific membrane antigen. ^([2]) Australian New Zealand Clinical Trials Registry ID: ACTRN12625000971437. ^([3]) Metastatic castration-resistant prostate cancer. ^([4]) Metastatic hormone-sensitive prostate cancer. ^([5]) Steinhelfer et al. _J Nucl Med._ 2024. ^([6]) Omar et al., presented at the European Association of Nuclear Medicine 2025 Annual Congress. ^([7]) ClinicalTrials.gov ID: [NCT06520345](https://clinicaltrials.gov/study/NCT06520345). ^([8]) Telix ASX disclosure March 10, 2026. |   --- | This article was produced by Cision PR Newswire, our trusted news partner. The views expressed and the content presented here are solely those of the author and may not fully reflect the opinions of Thailand Business News. | --- **Read the original article :** [OPTIMAL-PSMA Trial of TLX597-Tx Next Generation RLT Presented at IPCS 2026 Highlighting Therapeutic Potential in Prostate Cancer ](http://www.prnasia.com/story/archive/4946660_AE46660_0?rand=184833)