FivepHusion has announced the successful completion of the Phase 1 component of the Deflexifol at Relapse Trial (DART), supported by the Kids with Cancer Foundation, an Australian-led study of a new brain cancer treatment for children.
Deflexifol is an advanced clinical-stage, next-generation co-formulation of 5-fluorouracil and leucovorin. Deflexifol has previously been evaluated in two successfully completed clinical trials in adults with various solid tumours.
In the Phase 1 component, nine patients with a variety of brain cancers were treated with Deflexifol monotherapy at paediatric oncology centres around Australia.
An independent Data Safety Monitoring Committee consisting of adult and paediatric oncologists reviewed the trial participants’ safety and tolerability data. It declared a Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Deflexifol in paediatric brain cancer patients.
FivepHusion said the MTD, RP2D and other clinical and scientific data from DART Part A are being collated and will be presented at a paediatric oncology conference later this year.
Deflexifol is now poised to be investigated further in the Phase 2 component of DART, an ethics-approved study designed to evaluate the anti-tumour activity of Deflexifol in patients with refractory or recurrent ependymomas.
Dr Christian Toouli, the CEO and managing director of FivepHusion, said, “Completion of Part A of the DART study, and confirmation of a safe and tolerable phase 2 dose, are major milestones in our plans to develop Deflexifol® as a potential treatment for paediatric ependymoma and other 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.”