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FivepHusion Commences Deflexifol™ at Relapse Trial with Successful First Patient Treatment

Tuesday, September 05, 2023

FivepHusion announced the treatment for the first patient in the Deflexifol™ at Relapse Trial (DART) marks a pivotal moment in the advancement of therapies for paediatric brain cancers.

The DART Study, a phase 1b/2a clinical trial, is specifically designed to assess the potential of Deflexifol™ as a monotherapy for treating paediatric ependymoma and other childhood brain cancers.

Deflexifol™, an innovative clinical-stage formulation, combines the chemotherapy drug 5-fluorouracil (5-FU) with leucovorin (LV), a medication known to significantly enhance the effectiveness of 5-FU.

The initiation of treatment for the first patient in this trial is a highly significant milestone. It represents a promising step forward in the development of Deflexifol™ as a potential breakthrough therapy for paediatric brain cancers, where treatment options are limited.

Ependymomas, which are rare tumours originating from the ependymal cells lining the brain's ventricles and the central canal of the spinal cord, pose a formidable challenge. These tumours can arise at any age, with a higher incidence among young children (0-4 years) and older adults.

Currently, the standard of care for ependymoma involves surgical removal of the tumour followed by radiotherapy. However, it is disheartening to note that approximately half of all paediatric patients experience relapse, which is often associated with a grim prognosis.

Furthermore, there are currently no approved drugs specifically tailored for the treatment of ependymoma, underscoring the pressing need for safe and effective new therapeutic options. The initiation of the DART Study holds the promise of addressing this significant unmet medical need and improving outcomes for these vulnerable patients.

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