FivepHusion has announced that the first patient has commenced treatment as part of the Deflexifol at Relapse Trial (DART).
The company said the DART Study is a phase 1b/2a clinical trial investigating Deflexifol monotherapy as a treatment for paediatric ependymoma and other childhood brain cancers.
Several major paediatric oncology centres in Australia are participating in the trial, sponsored by the Australian and New Zealand Children’s Haematology - Oncology Group (ANZCHOG).
Deflexifol is an advanced clinical-stage, co-formulation of the chemotherapy drug 5-fluorouracil (5-FU) and leucovorin (LV), a drug that significantly enhances 5-FU activity.
FivepHusion said the priority development indications for Deflexifol are paediatric ependymoma and the first-line treatment of metastatic colorectal cancer (mCRC), with a global phase 3 registration trial planned to start in mCRC in late 2024.
Ependymomas are rare central nervous system tumours originating from the ependymal cells that line the brain's ventricles and the spinal cord's central canal. Tumours can manifest at any age, with peak incidence in young children and older adults. The current standard of care treatment for ependymoma is surgery and radiotherapy, though relapse occurs in approximately half of all paediatric patients and is associated with a poor prognosis. Currently, no drugs are approved for treating ependymoma, presenting a significant unmet medical need for safe and efficacious new treatments.
FivepHusion CEO and managing director Dr Christian Toouli said, “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. We thank the patients and their families for their participation in this trial, and our collaborators and partners for conducting this important study.”