On April 9, 2024 FivepHusion, an advanced clinical-stage biotechnology company, reported Human Regulatory Ethics Committee (HREC) approval for the next clinical trial of Deflexifol, an optimised all-in-one formulation of the chemotherapeutic agent 5-fluorouracil (5-FU) and its biomodulator leucovorin (LV), for the treatment of solid tumours (Press release, FivepHusion, APR 9, 2024, View Source [SID1234641929]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Bellberry Ltd, Australia’s leading independent organisation providing scientific and ethical review of human research projects, has approved the clinical trial protocol and patient consent documentation for the Deflexifol "FP101B" trial. HREC approval is a mandatory requirement prior to clinical trial initiation.
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 and 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 III registration study designed to confirm the superiority of Deflexifol over standard of care 5-FU/LV "backbone" therapy in unresectable mCRC.
This ethics approval follows strong enthusiasm from oncologists to a poster presentation describing the rationale and design of FP101B, presented at the November, 2023 Australasian Gastro-Intestinal Trials Group (AGITG) Annual Scientific Meeting in Christchurch, New Zealand. Deflexifol is an optimised co-formulation of 5-FU and LV that requires no change in clinical practice whilst offering superior safety and efficacy for cancer patients.
Dr Christian Toouli, CEO & Managing Director, commented, "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."