Ariceum Therapeutics Granted UK Authorisation to Conduct Phase I Clinical Study of its First-in-Class Iodine-123 Labelled PARP Inhibitor in Patients with Recurrent Glioblastoma
Berlin, Germany, 29th February 2024 – Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat 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, its Iodine-123 labelled PARP inhibitor, in patients with recurrent glioblastoma.
The authorisation follows Ariceum’s submission of a Clinical Trial Authorisation (CTA) application to the MHRA in December 2023 with the Phase 1 study expected to commence in the UK in June 2024. Ariceum is the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma, an aggressive form of brain cancer.
Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: “It is a tremendous achievement for Ariceum to receive CTA approval by the MHRA so soon after submission. Glioblastoma is the most common and most aggressive type of malignant brain tumour in adults, with a very poor prognosis for survival and currently no cure. Following the integration of Theragnostics into Ariceum and promising pre-clinical results, we welcome the opportunity to be the first company to trial Auger therapy for this indication and we plan to explore other solid tumour indications in the future.”
Dr Austin Smith, Medical Oncologist advising Ariceum Therapeutics, commented: “The CITADEL-123 study will allow us to demonstrate the safety and efficacy of ATT001 as a potential treatment option to address the high unmet medical need of patients with Glioblastoma. We are thankful 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 way to cancer cells expressing PARP, an enzyme they use to repair its DNA. This radioisotope emits low energy Auger electrons, which deposit their energy over short distances, making them particularly useful for causing lethal damage to cancer cells while sparing healthy tissue. An additional benefit of using Iodine-123 is that this isotope is more widely available than others, being produced in a regular cyclotron. Ariceum in parallel is also exploring 123I-ATT001 in other solid tumour indications, as PARP is a validated target, highly expressed in several other cancers.
For further information, please contact:
Ariceum Therapeutics
Manfred Rüdiger, CEO
Email: info@ariceum-therapeutics.com
Optimum Strategic Communications
Charlotte Hepburne-Scott, Zoe Bolt, Elena Bates
Tel: +44 (0) 20 3882 9621
Email: ariceum@optimumcomms.com
