Pharma Focus Europe

Ariceum Therapeutics Initiates Application for UK Clinical Trial Authorization to Evaluate First-of-its-Kind Iodine-123 Labeled PARP Inhibitor in Patients with Recurrent Glioblastoma

Thursday, January 11, 2024

Ariceum Therapeutics, a private biotech company focused on developing radiopharmaceutical products for challenging cancers, has officially submitted an application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for approval to conduct a Phase 1 trial of 123I-ATT001. This novel PARP inhibitor, labeled with Iodine-123, is designed for patients with recurrent glioblastoma, an aggressive form of brain cancer.

This application follows Ariceum's acquisition of Theragnostics Ltd, a private UK-based biopharmaceutical company, in June 2023. Theragnostics had previously been involved in the initial development of 123I-ATT001. Ariceum is now the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma.

Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, emphasized the urgent need for a solution for glioblastoma, a highly malignant and prevalent brain tumor with a grim prognosis and no current cure. He expressed enthusiasm about the potential of 123I-ATT001, a targeted Auger electron therapy that has shown promising pre-clinical results.

Rüdiger highlighted the significance of the swift application for clinical trial authorization in the UK following the integration of Theragnostics into Ariceum Therapeutics. He noted that besides advancing potential treatments for glioblastoma, this development opens avenues to explore the application of this molecular radiotherapy in treating other solid tumor indications.

The mechanism of action for ATT001 involves delivering its radioisotope payload, Iodine-123, in a highly targeted manner to cancer cells expressing PARP. These cells utilize PARP for self-repair. The emitted low-energy Auger electrons then selectively deposit their energy within short distances, making them effective in causing lethal damage to cancer cells while minimizing harm to healthy tissue. The use of widely available Iodine-123, produced in a regular cyclotron, adds practical advantages to this approach.

Ariceum is actively investigating the application of 123I-ATT001 in other solid tumor indications, considering PARP as a validated target expressed in various cancers.

The announcement coincided with Manfred Rüdiger's presence at the Biotech Showcase in San Francisco from January 8-10, 2024. Interested parties were invited to reach out for potential meetings during the event.



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