FivepHusion has announced that the Human Regulatory Ethics Committee (HREC) has approved the next clinical trial of Deflexifol.
Deflexifol is an an optimised all-in-one formulation of the chemotherapeutic agent 5-fluorouracil (5-FU) and its biomodulator leucovorin (LV), for treating solid tumours.
Bellberry has approved the clinical trial protocol and patient consent documentation for the FP101B trial.
FP101B is a planned multi-centre phase 1b dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Deflexifol in combination with oxaliplatin and bevacizumab as a first-line treatment for unresectable metastatic colorectal cancer (mCRC).
The trial design is based on US FDA advice. It will be the fourth clinical study investigating Deflexifol as a treatment for solid tumours and the first to study Deflexifol in combination with other standard-of-care drugs as a first-line treatment.
FP101B will be conducted by FivepHusion strategic partner Syneos Health, a leading fully integrated global biopharmaceutical solutions organisation.
The goal of the FP101B trial is to confirm the optimal dose of Deflexifol to be investigated in a planned global Phase 3 registration study.
FivepHusion CEO and managing director Dr Christian Toouli said, "There is a significant unmet medical need to optimise standard of care 5-FU/LV therapy for solid tumour treatment. This HREC approval endorses the feedback we have received from oncologists and the US FDA on the appropriateness of investigating Deflexifol as an optimised replacement of 5-FU/LV in the standard of care for the first-line treatment of mCRC. We intend to initiate this trial as soon as possible."
