Pharma Focus Europe

Ariceum Therapeutics Granted Regulatory Approval in the UK for Phase I Clinical Trial of First-of-its-Kind Iodine-123 Labelled PARP Inhibitor in Patients with Recurrent Glioblastoma

Friday, March 01, 2024

Ariceum Therapeutics (Ariceum), a private biotech company specializing in the development of radiopharmaceutical products for the diagnosis and treatment of challenging cancers, is pleased to announce that it has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to undertake a Phase 1 clinical trial (CITADEL-123) of 123I-ATT001. This PARP inhibitor labeled with Iodine-123 will be tested in patients with recurrent glioblastoma.

This approval follows Ariceum's submission of a Clinical Trial Authorisation (CTA) application to the MHRA in December 2023. The Phase 1 study is expected to begin in the UK in June 2024. Ariceum is notable for being the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma, an aggressive form of brain cancer.

Ariceum Therapeutics, stated: "It is a significant achievement for Ariceum to receive CTA approval from the MHRA shortly after submission. Glioblastoma presents a severe challenge in oncology, with poor survival rates and no current cure. With the integration of Theragnostics into Ariceum and promising pre-clinical results, we are excited to be the first to trial Auger therapy for this indication and look forward to exploring other solid tumor indications in the future."

Dr. Austin Smith, Medical Oncologist advising Ariceum Therapeutics, added: "The CITADEL-123 study will allow us to demonstrate the safety and efficacy of ATT001 as a potential treatment option for addressing the high unmet medical need of patients with Glioblastoma. We are grateful for the continued collaboration with the team at UCLH, led by Dr. Paul Mulholland, and the support of the patient advocacy group, Braintrust - the brain cancer people."

ATT001 delivers its radioisotope payload, Iodine-123, in a highly targeted manner to cancer cells expressing PARP, an enzyme crucial for DNA repair. This radioisotope emits low-energy Auger electrons, which deposit their energy over short distances, making them effective in damaging cancer cells while sparing healthy tissue. Additionally, the use of Iodine-123 offers the advantage of wider availability compared to other isotopes, as it is produced in standard cyclotrons. Ariceum is also investigating 123I-ATT001 in other solid tumor indications, leveraging PARP's status as a validated target highly expressed in several cancers.



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