Telix Launches SOLACE Trial


Telix Doses First Patient in SOLACE Trial for Metastatic Bone Pain - Telix Pharmaceuticals

New Bone Pain Treatment Enters Testing as Alternative to Proven Radium-223 Therapy

TLX090 offers potential convenience advantages, but must prove it can match survival benefits of established treatment

Telix Pharmaceuticals has initiated the SOLACE clinical trial, dosing the first patient with TLX090, an investigational radiopharmaceutical for metastatic bone pain. The Phase 1 study arrives as patients and physicians increasingly recognize both the promise and limitations of radium-223 (Xofigo®), the only bone-targeting therapy proven to extend survival in men with advanced prostate cancer.

The Challenge: When Cancer Spreads to Bone

Up to 90% of men with metastatic prostate cancer develop bone metastases, with approximately 400,000 new cases diagnosed annually across all cancer types. The resulting pain profoundly diminishes quality of life and mental health, yet current treatment options remain inadequate.

Opioids provide only partial relief while introducing risks of sedation, constipation, and dependency—concerns amplified by the opioid crisis. External beam radiation therapy targets only localized areas and proves impractical for patients with widespread bone pain. Neither approach extends survival.

The Proven Standard: Radium-223

Radium-223 represented a breakthrough when FDA approval came in 2013. The landmark ALSYMPCA trial demonstrated a 30% reduction in death risk compared to placebo, extending median survival by 3.6 months (14.9 vs. 11.3 months). The drug also delayed skeletal complications including pathologic fractures, spinal cord compression, and the need for additional radiation therapy.

As a calcium-mimetic alpha-particle emitter, radium-223 accumulates in areas of active bone turnover where metastases form. Its alpha particles travel less than 100 microns—approximately four one-thousandths of an inch—delivering intense, highly localized radiation that causes double-strand DNA breaks while limiting damage to surrounding healthy tissue. This extremely short range makes it very safe for patients and close contacts.

The treatment requires six intravenous injections given every four weeks, with each outpatient appointment taking around 30 minutes. Side effects include temporary bone pain increase, gastrointestinal symptoms, and decreased blood counts, but myelotoxicity (bone marrow suppression) is generally minimal.

After more than a decade of clinical use, researchers have refined their understanding of radium-223. Recent studies show it works best in micro-tumors rather than large established metastases, suggesting optimal use early in bone-metastatic disease. Imaging techniques using 18F-sodium fluoride PET scans can now predict which patients will respond best, allowing clinicians to target treatment more precisely.

Intriguingly, radium-223 may benefit even asymptomatic patients with favorable baseline characteristics, not just those with severe bone pain—expanding its potential role beyond late-stage palliation.

The New Contender: TLX090

TLX090 uses Samarium-153, a beta-particle emitter bound to DOTMP, a bone-seeking compound. Like radium-223, it targets areas of active bone turnover, but the different radiation type has important implications.

Beta particles travel farther than alpha particles, potentially providing broader coverage but with more collateral damage to surrounding tissue. This represents a fundamental trade-off: radium-223's highly localized alpha radiation versus samarium's more diffuse beta radiation.

The SOLACE trial (Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage bone pain) will enroll up to 33 patients with advanced cancer metastasized to bone. As a Phase 1 study, it focuses on evaluating pharmacokinetics, dosimetry, safety, and pain relief—not yet survival benefits.

However, TLX090 offers potential practical advantages. A single administration could deliver 3-4 months of pain relief with the ability to provide repeat doses—compared to radium-223's six separate infusions over 24 weeks. The drug's novel cold-kit formulation and pharmacy-based distribution may overcome cost and supply chain barriers associated with legacy radiopharmaceuticals.

"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," said Dr. Julio A. Peguero, Medical Director of Research at Oncology Consultants in Houston, where the trial is being conducted.

Dr. David N. Cade, Telix's Group Chief Medical Officer, emphasized the broader opportunity: "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."

The Critical Question: Pain Relief vs. Survival

Here lies the essential distinction. Historical samarium-153 treatments provided palliative pain relief without life-prolonging effects—a significant limitation compared to radium-223's proven survival benefit.

TLX090 aims to establish "clinical comparability" to these legacy samarium treatments, potentially enabling a streamlined regulatory pathway as an analgesic. But whether this next-generation formulation can match radium-223's survival advantage remains unknown. Early study data showed a favorable safety profile and encouraging efficacy signals, but comprehensive Phase 1 results are pending.

The treatment landscape for metastatic castration-resistant prostate cancer has evolved significantly, with radium-223 now joined by lutetium-177-PSMA-617 (Pluvicto®) as the only two radiopharmaceuticals proven to extend survival. Radium-223 targets bone specifically, while Lu-PSMA targets both bone and soft tissue metastases in patients with PSMA-positive tumors who have received prior chemotherapy and hormonal therapy.

What This Means for Patients

For men currently facing bone metastases from castration-resistant prostate cancer, radium-223 remains the established standard with documented survival benefits extending beyond pain management. Patients should discuss with their oncology teams whether they're candidates, particularly given emerging evidence that earlier treatment—even in asymptomatic patients—may provide optimal results.

TLX090 represents a potentially important addition to the therapeutic arsenal, especially if its convenience and cost advantages materialize. A single-dose treatment delivering months of relief would significantly reduce treatment burden. However, as an investigational agent still in early-phase testing, it has not received marketing authorization in any jurisdiction.

The key questions facing the SOLACE trial: Can this optimized samarium formulation deliver not just pain relief, but meaningful survival extension? Can it match radium-223's dual benefit of symptom control and prolonged life? Until these questions are answered through rigorous clinical trials, radium-223 stands as the proven option for patients and physicians seeking both quality and quantity of life.

As cancer treatments continue extending survival in advanced disease, the need for effective, well-tolerated bone pain management becomes increasingly critical. Whether TLX090 ultimately complements or competes with radium-223, its development reflects ongoing efforts to address one of prostate cancer's most debilitating complications.

Patients interested in clinical trial participation may inquire through their healthcare providers. Those seeking more information about established bone-targeted therapies should consult their oncology teams to determine the most appropriate treatment strategy for their individual circumstances.

Sources

  1. Telix Pharmaceuticals. (2025, October 23). Telix Doses First Patient in SOLACE Trial for Metastatic Bone Pain. https://www.telixpharma.com

  2. Parker, C., et al. (2013). Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa1213755

  3. Sartor, A. O., et al. (2014). Ra-223 Treatment for Bone Metastases in Castrate-Resistant Prostate Cancer: Practical Management Issues for Patient Selection. BMC Cancer. https://pmc.ncbi.nlm.nih.gov/articles/PMC6445613/

  4. Nguyen, N. C., et al. (2017). Usefulness of radium-223 in patients with bone metastases. Frontiers in Oncology. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5595381/

  5. UK National Health Service. (2023). Radium-223 for the treatment of prostate cancer bone metastases. https://www.gloshospitals.nhs.uk/your-visit/patient-information-leaflets/radium-223-for-the-treatment-of-prostate-cancer-bone-metastases/

  6. Sartor, O., et al. (2019). Radium-223 in asymptomatic patients with castration-resistant prostate cancer and bone metastases treated in an international early access program. BMC Cancer. https://bmccancer.biomedcentral.com/articles/10.1186/s12885-018-5203-y

  7. National Cancer Institute. (2013). Radium-223 for Advanced Prostate Cancer. https://www.cancer.gov/types/prostate/research/radium-223-improves-survival

  8. Parker, C., et al. (2023). Scientists now able to predict response to radium-223 treatment in prostate cancer bone metastases. Institute of Cancer Research. https://www.icr.ac.uk/about-us/icr-news/detail/scientists-now-able-to-predict-response-to-radium-223-treatment-in-prostate-cancer-bone-metastases

  9. Vogelzang, N. J., et al. (2017). Optimal usage of radium-223 in metastatic castration-resistant prostate cancer. Therapeutic Advances in Urology. https://www.sciencedirect.com/science/article/pii/S0929664616302492

  10. Suominen, M. I., et al. (2019). Radium 223-Mediated Zonal Cytotoxicity of Prostate Cancer in Bone. JNCI: Journal of the National Cancer Institute. https://ncbi.nlm.nih.gov/pmc/articles/PMC6792112/

  11. Maughan, B., et al. (2023). Radium-223: A Decade of Treating Metastatic Castration-Resistant Prostate Cancer. Harborside Press. https://sponsored.harborsidestudio.com/radium-223-a-decade-of-treating-metastatic-castration-resistant-prostate-cancer/

Note: TLX090 is an investigational drug that has not been approved by regulatory authorities. The information presented here is for educational purposes and should not be considered medical advice. Patients should consult with their healthcare providers regarding treatment options.

 

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