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Treatment Sees Tumour Reduced in Size by 50 Per Cent 

To mark International Brain Tumour Awareness Week, UCLH and The National Brain Appeal are announcing a new clinical trial for patients with recurrent glioblastoma brain cancer. 

Paul, a 62 year old engineer, was diagnosed with glioblastoma brain cancer in December 2023. Following the standard treatment of surgery, radiotherapy and chemotherapy, Paul received the news in July this year that his tumour had become active again. 

Paul is the first patient to be recruited to a new clinical trial that has opened at UCLH. Scans revealed a 50 per cent reduction in his tumour at the end of treatment. 

The trial, CITADEL-123, was designed by UCLH consultant medical oncologist, Dr Paul Mulholland, who is also the chief investigator.  

Patients who have had standard treatment, who now have recurrent disease and are fit and well enough for treatment can undergo resection surgery at The National Hospital for Neurology and Neurosurgery. As much tumour as is safe will be removed and they will then have a small medical device called an Ommaya reservoir implanted under the scalp and this connects via a small tube into the tumour area.

The tube then allows the nuclear medicine team at University College Hospital to inject the drug – ATT001, Iodine-123 labelled PARP inhibitor – to target the tumour, delivering small amounts of radioactivity. This takes place approximately 14 days after surgery and patients will have weekly injections for 4 to 6 weeks. 

The drug is very potent over short distances, reaching the cancer cell it comes into contact with. The radioactivity should damage and hopefully kill the tumour cells.

ATT001 delivers its radioisotope payload, Iodine-123, in a highly targeted way to cancer cells expressing PARP, an enzyme they use to repair themselves. 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. 

The trial is sponsored by Ariceum Therapeutics, a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, who received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) earlier this year to undertake the Phase 1 clinical trial in patients with recurrent glioblastoma. The project was approved as an Innovative Licensing and Access Pathway (ILAP) project by MHRA. 

The dose escalation study will be followed by expansion cohorts at a recommended dose in monotherapy and in combination with other therapies in recurrent glioblastoma, with the potential to move into primary glioblastoma. 

Ariceum is the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma, an aggressive form of brain cancer. 

Dr Mulholland, consultant medical oncologist at UCLH, who leads the Glioblastoma Research Group at the UCL Cancer Institute, said: “We have been working with Ariceum Therapeutics for some years to develop this study. It will allow us to deliver low levels of radioactivity directly into the tumour of patients with recurrent glioblastoma. I’m very pleased that this clinical trial is now open. Potentially this is a very powerful approach and I’m already extremely happy with the results from the first patient. I’m also very proud at how my colleagues in neurosurgery and nuclear medicine have come together as a team to deliver a really novel trial.” 

Dr Austin Smith, consultant medical oncologist at Ariceum Therapeutics, said: “The CITADEL-123 study will allow us to demonstrate the safety and initial efficacy of ATT001 as a potential treatment option to address the high unmet medical need of patients with recurrent glioblastoma.” 

Dr Mulholland’s neurosurgical colleagues at the National Hospital for Neurology and Neurosurgery (NHNN), Ms Huma Sethi, Professor Andrew McEvoy and Ms Anna Miserocchi and nuclear medicine consultant at University College Hospital, Professor Jamshed Bomanji, have all been instrumental in making this trial happen. 

Praising their joint working, medical director of the specialist hospitals board, Dr Tim Hodgson, said: “This trial has been a great team effort of many different specialties across Queen Square and UCLH, coming together to focus on finding new ways of treating glioblastoma.” 

Dr Mulholland is passionate about finding a cure for brain cancer. The National Brain Appeal charity has long-supported his work, providing funding for the UK’s largest-ever immunotherapy trial for brain cancer patients (IPI-GLIO) and funding specialist research posts in his team. 

Dame Siobhain McDonagh MP, who lost her sister, Baroness Margaret McDonagh, to glioblastoma is also supporting Dr Mulholland’s work. Dame Siobhain is calling for a target of getting 200 glioblastoma patients into clinical trials each year; for drugs licensed for other tumours to be trialled on brain tumours; for a requirement that every NHS neuro-oncology multidisciplinary team includes a medical oncologist; and that every NHS doctor training to be a medical oncologist should go through a mandatory course on brain tumours. 

The CITADEL-123 trial will be open for around eighteen months and UCLH is currently the only centre recruiting patients, with other sites due to open at a later date. 

Catalyst: Fri 8 November 2024, 14:16
Biosynth: Wed 13 November 2024, 10:18