Treatment has commenced for the initial patient in the Deflexifol™ at Relapse Trial (DART), aimed at investigating paediatric ependymoma and other brain cancers, marking a pivotal moment in FivepHusion’s journey towards bringing Deflexifol™ to the market.
The Deflexifol™ at Relapse Trial
The DART study is a phase 1b/2a clinical trial that is investigating Deflexifol™ monotherapy as a potential treatment for paediatric ependymoma and various other childhood brain cancers.
The initial part of this trial aims to assess the safety and tolerability of Deflexifol™, with a focus on determining the maximum tolerable dose and the recommended phase 2 dose in paediatric patients facing refractory or recurrent central nervous system tumours. Patients that have newly diagnosed diffuse intrinsic pontine glioma (DIPG) or diffuse midline glioma (DMG) who have already undergone radiotherapy may also be evaluated in the trial.
In the subsequent part of the trial, the focus lies on investigating the recommended phase 2 dose to gauge the efficacy of Deflexifol™ in combating tumours among patients diagnosed with refractory or recurrent ependymoma. The assessment will encompass parameters such as response rate, progression-free survival, and overall survival.
This groundbreaking trial is sponsored by the Australian and New Zealand Children’s Haematology/Oncology Group, with active participation from all major paediatric oncology centres across Australia.
Deflexifol™ Journey to Market
FivepHusion continues to make significant progress in their efforts to bring Deflexifol™ to market. In June the Company successfully concluded a dose-escalation clinical study, which was designed to investigate the safety tolerability and maximum tolerated dose of Deflexifol™ when used to treat adults with advanced solid tumours following failure of standard therapies.
The revolutionary, advanced clinical stage treatment, aims to change the standard of care in chemotherapy, providing a next-generation co-formulation of the chemotherapy drug 5-fluorouracil (5-FU) and leucovorin (LV), a drug known for its ability to significantly enhance the activity of 5-FU.
FivepHusion intends to harness the proven cytotoxic activity of 5-FU, combined with the uniquely optimised attributes of the Deflexifol™ co-formulation, to advance its development in addressing critical unmet medical needs in a variety of solid tumour indications currently undersevered byt standard therapy.
The priority indications for Deflexifol™ development are frontline therapy for metastatic colorectal cancer, and paediatric ependymoma.
To further its commitment to innovative cancer treatments, FivepHusion is now working towards a global phase III registration trial, which is slated to commence by the end of 2024.
The prospect of bringing Deflexifol™ to the market poses considerable potential benefits for patients. Endymomas are a rare type of brain tumour that mostly affects young children aswell as older adults.
Treatment options are limited to surgical intervention and radiotherapy. Sadly, relapse occurs in nearly half of all paediatric patients and is associated with a poor prognosis.
Currently, there are no pharmaceutical drugs that are approved or have shown significant benefit in treating ependymoma, emphasising the pressing need for the development of safe and effective new treatments in this critical area.
FivepHusion is dedicated to advancing Deflexifol™ development through strategic clinical and commercial value-add collaborations
In August, the Company announced its partnership with Allarity Therapeutics (Nasdaq: ALLR) to explore the potential of a precision medicine approach by integrating Allarity’s DRP®-5FU companion diagnostic into the clinical development of Deflexifol™.
FivepHusion has additionally forged a strategic alliance with Pfizer CentreOne for the scale-up and commercial manufacture of Deflexifol™, providing extensive expertise and capabilities in the commercial manufacture of cytotoxic drugs and enabling global distribution through its existing supply network.
FivepHusion CEO and Managing Director Dr Christian Toouli commented on the significance of the first patient trial.
“Treatment of the first patient in the DART Study is a very important milestone for the development of Deflexifol™ as a promising new therapy for paediatric brain cancers,” he said.
“We thank the patients and their families for their participation in this trial, and our collaborators and partners for conducting this important study.”