Telix Doses First Patient in SOLACE Trial for Metastatic Bone Pain

Rhea-AI Summary

Telix (ASX: TLX, NASDAQ: TLX) announced dosing of the first patient in the Phase 1 SOLACE trial of TLX090 (153Sm-DOTMP) on Oct 22, 2025. SOLACE is an open-label study enrolling up to 33 patients with advanced cancer and bone metastases to evaluate pharmacokinetics, dosimetry, safety, and pain palliation. TLX090 is described as a next-generation radiopharmaceutical optimized to target bone tumors and potentially provide a non-opioid systemic option for durable pain relief.

The program aims to compare TLX090 to legacy 153Sm treatments to support a streamlined registration pathway; TLX090 has not received marketing authorization in any jurisdiction.

Positive

• First patient dosed in Phase 1 SOLACE trial
• SOLACE enrollment up to 33 patients
• TLX090 intended as systemic, non-opioid pain therapy
• Company cites potential 3–4 months pain relief per dose

Negative

• TLX090 has not received marketing authorization in any jurisdiction
• Evidence currently limited to Phase 1 study and an earlier, non‑definitive study
• Small trial size (33 patients) limits near-term statistical power

Insights

Clinical Development Strategist

Phase 1 dosing for a targeted radiopharmaceutical is a meaningful early clinical milestone with still-limited immediate commercial implications.

Telix has initiated dosing in the open-label Phase 1 SOLACE study of TLX090 to evaluate pharmacokinetics, dosimetry, safety and pain palliation in up to 33 patients with bone metastases; this confirms the program has moved from preclinical/IND‑enabling work into human testing and allows collection of first-in-human safety and dosimetry data.

The core dependencies are clear: demonstration of an acceptable safety/tolerability profile, demonstrable pain palliation versus historical 153Sm results to support the company’s claim of clinical comparability, and usable dosimetry for repeat dosing. Risks include small Phase 1 cohort size, open‑label design limiting efficacy certainty, and the need to show at least a meaningful analgesic signal and safety to enable a streamlined registration pathway.

Watch for reported safety outcomes, dosimetry metrics, and any pain‑relief responder rates or duration statements in initial data releases; key near‑term milestones are initial safety readouts and any dose‑finding results expected after early cohorts complete dosing and follow‑up (study enrollment and readout timing will determine horizon).

MELBOURNE, Australia and INDIANAPOLIS, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has dosed the first patient in a Phase 1 clinical trial of TLX090 (¹⁵³Samarium (Sm)-DOTMP), a therapeutic radiopharmaceutical candidate for treating pain associated with bone metastasis.

TLX090 is designed to deliver targeted radiation to bone tumors while minimizing damage to surrounding healthy tissues. SOLACE (Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage bone pain) is an open-label Phase 1 clinical trial enrolling up to 33 patients with advanced cancer that has metastasized to the bony skeleton¹. The trial is designed to evaluate the pharmacokinetics, dosimetry, safety, and pain palliation of TLX090, a next-generation radiopharmaceutical candidate optimized for improved safety profile and efficacy. Data from SOLACE aims to establish clinical comparability to legacy ¹⁵³Sm treatments, which in turn is expected to support a streamlined registration pathway as an analgesic, paving the way for a much-needed, non-opioid solution for patients living with bone pain in the late stages of advanced cancer.

Pain from osteoblastic bone metastases is one of the most common and debilitating symptoms in advanced cancer, with approximately 400,000 new cases diagnosed² each year. Up to 90% of patients with metastatic prostate cancer^3,4 are affected, contributing to reduced quality of life and mental health. Despite the availability of opioids and external beam radiation therapy (EBRT), many patients remain under-treated — underscoring a critical unmet need for a systemic, targeted, and non-opioid solution that can deliver durable relief across multiple cancer types.

The current standard of care can provide only partial relief⁵ and comes with significant drawbacks. Opioids are associated with sedation, constipation, dependency, and regulatory scrutiny, especially in the post-Purdue litigation era⁶. Health systems face high costs and administrative burdens in managing chronic opioid use, including monitoring, compliance, and risk mitigation. EBRT is often ineffective⁷ as it is localized, logistically intensive, and not suitable for patients with multifocal or diffuse bone pain.

By comparison, TLX090 offers the potential for a cost-effective, systemic, targeted and non-opioid alternative that may treat pain, reduce reliance on chronic pain medications and improve quality-of-life through a single administration that could deliver up to 3-4 months of pain relief, with the ability to provide repeat doses. An earlier study⁸ demonstrated a favorable early safety profile and encouraging efficacy signal, while the potential to treat pain associated with multiple cancer types expands Telix’s clinical reach into disease areas such as prostate, and breast cancer. The novel cold-kit formulation and pharmacy-based distribution of TLX090 may also aid in overcoming barriers to treatment due to cost and supply chain limitations associated with legacy products.

Julio A. Peguero MD, Medical Director of Research, Oncology Consultants, Houston (TX), said, “We are proud to support the SOLACE trial, which brings new hope to patients living with metastatic bone pain. Existing treatments often fall short—whether through limited effectiveness, incomplete pain relief, or burdensome side effects. TLX090 offers the potential for a better tolerated and more effective approach to pain management, with the goal of meaningfully improving patients’ quality of life.”

David N. Cade MD, Group Chief Medical Officer, Telix, said, “Even with the introduction of new treatments, including targeted radiation therapy, most metastatic cancer patients will eventually progress and need treatment for bone pain. TLX090 has the potential to bridge cancer treatment and quality-of-life care by offering a single-dose, systemic option for these patients addressing the significant unmet need across multiple cancer types. This presents a major clinical opportunity, aligned with our commitment to prostate cancer, and a potential commercial entry point into the therapeutic market. Thank you to Oncology Consultants in Houston for partnering with us on this important clinical trial.”

TLX090 has not received a marketing authorization in any jurisdiction.

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, United Kingdom, Brazil, 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. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Visit 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, X and Facebook

Telix Investor Relations (Global)

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)  

Annie Kasparian  
Telix Pharmaceuticals Limited  
Director Investor Relations and Corporate Communications  
Email: annie.kasparian@telixpharma.com 

Media Contact

Eliza Schleifstein
Eliza@schleifsteinpr.com

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Cautionary Statement Regarding Forward-Looking Statements. 

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©2025 Telix Pharmaceuticals Limited. All rights reserved.

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¹ ClinicalTrials.gov ID: NCT07197645.
² Huang et al. Ann Transl Med. 2020.
³ Guo et al. Skelet Radiol. 2025
⁴ Woolf et al. Annals of Oncology. 2015.
⁵ Corli et al. Annals of Oncology. 2016.
⁶ The period following the landmark legal actions against Purdue Pharma, the maker of OxyContin, for its role in the U.S. opioid crisis.
⁷ De Felice et al. Oncotarget. 2017; Huisman et al. Int J Radiat Oncol Biol Phys. 2012.
⁸ QSAM-101 Study data on file.

FAQ

What did Telix announce on Oct 22, 2025 about TLX090 (TLX)?

Telix announced dosing the first patient in the Phase 1 SOLACE trial of TLX090 (153Sm-DOTMP) on Oct 22, 2025.

How many patients will the SOLACE trial for TLX090 (TLX) enroll?

SOLACE is an open-label Phase 1 trial enrolling up to 33 patients with metastatic bone pain.

What endpoints will the SOLACE Phase 1 trial for TLX090 (TLX) evaluate?

The trial will evaluate pharmacokinetics, dosimetry, safety, and pain palliation.

Does TLX090 (TLX) have regulatory approval for treating bone pain?

No; TLX090 has not received marketing authorization in any jurisdiction.

What pain relief duration does Telix describe for TLX090 (TLX)?

Telix describes the potential for a single administration to provide up to 3–4 months of pain relief, with repeat dosing possible.

What is the intended commercial or clinical advantage of TLX090 (TLX)?

Telix positions TLX090 as a targeted, systemic, non-opioid alternative for multifocal bone pain, with a cold-kit pharmacy distribution model.