ATT001 / Ariceum Therap - LARVOL DELTA

CITADEL-123: Phase 1 Open-label Study of 123I-ATT001 in Subjects with Relapsed Glioblastoma (clinicaltrials.gov) - P1 | N=67 | Recruiting | Sponsor: Theragnostics Ltd

New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Ariceum Therapeutics Commences Phase 1 Clinical Trial in Patients with Recurrent Glioblastoma (PRNewswire) - "Ariceum Therapeutics...today announces that it has commenced a Phase 1 first-in-human clinical trial (CITADEL-123) of 123I-ATT001, its Iodine-123 labelled PARP inhibitor, in patients with recurrent glioblastoma. The trial opened at University College London Hospitals (UCLH) and will assess the safety and early efficacy of Ariceum's radiotherapeutic candidate, ATT001...The trial has commenced at UCLH, with other sites due to open in the UK and EU later this year."

Trial status • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

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 (PRNewswire) - "Ariceum Therapeutics (Ariceum)...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."

Trial status • Glioblastoma

Ariceum Therapeutics files for UK Clinical Trial Authorisation (CTA) to test its First-in-Class Iodine-123 labelled PARP inhibitor in patients with recurrent glioblastoma (PRNewswire) - "Ariceum Therapeutics...announces it has submitted an application with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to undertake a Phase 1 trial of 123I-ATT001, its Iodine-123 labelled PARP inhibitor in patients with recurrent glioblastoma."

New P1 trial • Glioblastoma

Ariceum Therapeutics Expands Pipeline with Acquisition of Theragnostics Ltd (PRNewswire) - "Ariceum Therapeutics...is pleased to announce the acquisition of Theragnostics Ltd...The acquisition provides Ariceum with an expanded portfolio of therapeutic and diagnostic assets in late preclinical and early clinical development. It also comprises NEPHROSCAN...Theragnostics' assets obtained by Ariceum include ATD 001 (formerly THG 008), a novel fluorine-18 radiolabelled PARP inhibitor for the imaging cancer, and AT-001 (formerly THG 009), a I-123-labelled PARP inhibitor which is in development for the treatment of aggressively growing cancers and already having UK ILAP approval for primary and recurrent glioblastoma."

M&A • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Theragnostics Announces that its Radiotherapeutic for Treatment of Glioblastoma Multiforme has been Awarded UK’s MHRA Innovation Passport (PRNewswire) - "Theragnostics...announces that its novel I-123 PARPi (THG-009) therapeutic agent has been awarded an Innovation Passport by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of primary and recurrent Glioblastoma Multiforme (GBM). This is provided under the MHRA's Innovative Licensing and Access Pathway (ILAP) which was launched in January 2021 to accelerate development and access to innovative medicines in the UK."

European regulatory • Glioblastoma • Oncology