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FivepHusion Trial Deflexifol™ Brain Tumor Treatment

15 June 2023 06:05
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FivepHusion maintains its momentum from its recent successful clinical trial results, with the up-and-coming bio-med company announcing the commencement of its next clinical trial to explore the potential of its flagship Deflexifol™ to treat paediatric brain cancer patients.

Keeping up the Pace

The trial will test Deflexifol™’s ability to treat a number of brain tumours, with recruitment of patients with relapsed central nervous system tumours (CNS), newly diagnosed diffuse intrinsic pontine glioma (DIPG)/diffuse midline glioma tumours (DMG) and ependymoma.

The trial will be split into two parts, with Part A investigating the safety and tolerability of the use of Deflexifol™ in the treatment of children and young adults with relapsed CNS tumours and newly diagnosed DIPG/DMG tumours that have completed radiotherapy.

Part A is set to determine the pharmacokinetics, maximum tolerated dose, and recommended phase two dosage (RP2D) in the use of Deflexifol™ in the treatment of these patients.

The second part of the trial will investigate the anti-tumour activity, progression-free survival and overall survival associated with Deflexifol™ being used as a monotherapy at the RP2D in patients with refractory or recurrent ependymoma.

Potentially the first approved drug treatment

The use of Deflexifol™ in treating ependymoma is of particular significance.

Ependymomas, despite being the third-most common tumour in children, currently lack approved drugs for treatment, with surgical resection and radiation therapy remaining the only available options.

While previous clinical data has shown promising anti-tumour activity by administration of standard-of-care anti-cancer drug 5-FU, dose-limiting toxicities present in traditional 5-FU formulations restricted it as an avenue for ependymoma treatment.

Deflexifol™ is set to address these limitations, with the drug previously demonstrating a maximum tolerated dose of ~40 per cent more 5-FU than is typically administered in clinical practice, which when combined with the drug’s ability to co-formulate 5-FU with its biomodulator LV simultaneously should allow for more effective anti-cancer activity over a longer period.

Strong Support

The investigator-led study will be undertaken at paediatric oncology centres across Australia and is led by Professor David Ziegler and Dr Marion Mateos at the Kids Cancer Centre and coordinated by the Sydney Children’s Hospital, Randwick, with additional support being offered by Cancer Institute NSW.

The trial is sponsored by the Australian and New Zealand Children’s Haematology / Oncology Group (ANZCHOG) and has received major funding support from the Kids with Cancer Foundation and the Robert Connor Dawes Foundation.

Dr Christian Toouli, CEO and Managing Director of FivepHusion commented, “We are excited to collaborate with Professor Ziegler, Dr Mateos and other participating clinicians, their teams and organisations, and are very grateful for the generous charity funding support enabling the investigation of Deflexifol™ as a promising new treatment for paediatric brain cancer patients.”

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