Telix Pharmaceuticals (ASX:TLX) has dosed the first patient in its Phase 1 clinical trial evaluating TLX090 (¹⁵³Samarium (Sm)-DOTMP), a next-generation therapeutic radiopharmaceutical being developed to treat pain associated with metastatic bone disease.
The open-label SOLACE study (Samarium Optimised for Long-lasting Analgesia in Cancerous End-stage bone pain) will enrol up to 33 patients with advanced cancers that have metastasised to the bony skeleton. It aims to assess pharmacokinetics, dosimetry, safety and pain palliation, and to establish clinical comparability with legacy samarium-153 treatments. Telix expects this could support a streamlined regulatory pathway for a non-opioid analgesic alternative.
Bone metastases remain one of the most common and debilitating complications of advanced cancer. Around 400,000 new cases are diagnosed globally each year, and up to 90 per cent of patients with metastatic prostate cancer experience bone pain, often with severe impacts on quality of life. Existing therapies such as opioids and external beam radiation offer only partial relief for many patients, often with significant side effects or practical limitations. TLX090 is designed to deliver targeted radiation to bone tumours while minimising damage to surrounding healthy tissue.
Telix believes TLX090 has the potential to offer durable pain relief for up to three to four months from a single administration, with the option for repeat dosing. Earlier data have indicated a favourable early safety profile and encouraging efficacy signals, while the cold-kit formulation and pharmacy-based distribution may help address cost and supply chain challenges associated with earlier-generation products.
Julio A. Peguero, MD, Medical Director of Research at Oncology Consultants in Houston, said the trial represents a critical step forward in pain management for patients with advanced cancer. “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,” he said.
Telix Group Chief Medical Officer David N. Cade, MD, said TLX090 could help close the gap between cancer treatment and quality-of-life care. “Even with the introduction of new treatments, including targeted radiation therapy, most metastatic cancer patients will eventually progress and need treatment for bone pain,” Dr Cade said. “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.”