Clinical-stage biotechnology company FivepHusion has announced Human Regulatory Ethics Committee (HREC) approval for the next clinical trial of Deflexifol to treat solid tumours.
Deflexifol is an optimised all-in-one formulation of the chemotherapeutic agent 5-fluorouracil (5-FU) and its biomodulator leucovorin (LV).
FivepHusion said Bellberry had 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 in patients with 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 it will be the first to study Deflexifol in combination with other standard-of-care drugs as a first-line treatment.
FivepHusion partner Syneos Health will conduct FP101B.
The trial goal is to confirm the optimal dose of Deflexifol to be investigated in a planned global phase 3 registration study designed to confirm the superiority of Deflexifol over standard-of-care 5-FU/LV therapy in unresectable mCRC.
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 1st line treatment of mCRC. We intend to initiate this trial as soon as possible.”