- Novel iodine radiolabelled PARP inhibitor (rPARPi) entering
clinical development in Phase 1 trial to assess safety and early
efficacy
- Dose escalation study followed by expansion cohorts in
recurrent glioblastoma with potential to move into primary
glioblastoma
BERLIN, July 25,
2024 /PRNewswire/ -- Ariceum Therapeutics
(Ariceum), a private biotech company developing radiopharmaceutical
products for the diagnosis and treatment of certain hard-to-treat
cancers, 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. UCLH consultant medical
oncologist, Dr Paul Mulholland,
designed the trial and is also chief investigator of the study.
Ariceum is the first company to sponsor a clinical trial of Auger
therapy for recurrent glioblastoma, an aggressive form of brain
cancer with a high unmet medical need.
The initiation of the Phase 1 clinical trial follows Ariceum's
submission of a Clinical Trial Authorisation (CTA) application to
the UK's Medicines and Healthcare products Regulatory Agency (MHRA)
in December 2023 and subsequent
approval received from the MHRA in February
2024. The trial has commenced at UCLH, with other sites due
to open in the UK and EU later this year. 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.
Manfred Rüdiger, Chief Executive Officer at Ariceum
Therapeutics, said: "The start of this clinical trial marks a
significant clinical milestone for Ariceum's targeted radionuclide
therapy, ATT001, especially so soon after receiving approval from
the MHRA. We are very pleased to have begun the trial and hope it
will bring a much-needed therapy to patients affected by
glioblastoma, an aggressive and devastating form of brain
cancer."
Germo Gericke, Chief Medical Officer at Ariceum Therapeutics,
commented: "Recurrent glioblastoma is a very challenging brain
cancer with currently no cure and limited treatment options.
Ariceum's radiotherapeutic, ATT001, has demonstrated promising
pre-clinical results as a potential treatment for patients. We hope
to achieve further favourable results in the clinic from our
continued collaboration with the team at UCLH, led by Dr
Paul Mulholland."
Dr Paul Mulholland, who leads
the Glioblastoma Research Group at the UCL Cancer Institute,
added: "We have been working with Ariceum Therapeutics for
some years to develop this study. It will allow us to deliver a low
level of radioactivity directly into the tumour of patients with
recurrent glioblastoma. I'm very pleased that this clinical trial
is now opening."
ATT001 delivers its radioisotope payload, Iodine-123, in a
highly targeted way to cancer cells expressing PARP, an enzyme they
use to repair their 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 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.
Notes to Editors
About Ariceum Therapeutics
Ariceum Therapeutics (Ariceum) is a private, clinical stage
radiopharmaceutical company focused on the diagnosis and precision
treatment of certain neuroendocrine and other aggressive,
hard-to-treat cancers. The name Ariceum is an anagram of 'Marie
Curie' whose discovery of radium and polonium have been huge
contributions to finding treatments for cancer.
Ariceum's lead targeted systemic radiopharmaceutical product,
177Lu-satoreotide tetraxetan ("Satoreotide"), is an antagonist of
the somatostatin type 2 (SSTR2) receptor which is overexpressed in
neuroendocrine tumours (NETs) and some aggressive cancers such as
small cell lung cancer (SCLC), or Merkel Cell Carcinoma, all of
which have few treatment options and poor prognosis. Satoreotide is
being developed as a 'theranostic' pair for the combined diagnosis
and targeted radionuclide treatment of these tumours. Ariceum is
also developing a radiolabelled PARP-inhibitor (ATT001), which is
slated to enter clinical development in 2024. ATT001 was part of
the acquisition of Theragnostics Ltd which was closed in
June 2023.
Ariceum Therapeutics, launched in 2021, acquired all rights to
Satoreotide from Ipsen. Ipsen remains a shareholder in the Company.
Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, United
Kingdom and United States of
America and with activities currently across the globe.
Ariceum is led by a highly experienced management team and
supported by specialist investors including EQT Life Sciences
(formerly LSP), HealthCap, Pureos Bioventures, Andera Partners and
Earlybird Venture Capital. For further information, please
visit www.ariceum-therapeutics.com.
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SOURCE Ariceum Therapeutics