FivepHusion, an advanced clinical-stage biotechnology company, today announces 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.
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.”
About FivepHusion
FivepHusion (www.fivepHusion.com) is an advanced clinical-stage, globally focused biotechnology company whose purpose is to optimise chemotherapy to improve patient treatment outcomes and quality of life.
FivepHusion is developing Deflexifol™, a proprietary, novel, and optimised physiological pH formulation to co-administer the chemotherapeutic agent 5-fluorouracil (5-FU) and its biomodulator leucovorin (LV), a drug that significantly enhances 5-FU anti-cancer activity. These drugs are commonly used globally to treat various solid tumours including colorectal, pancreatic, gastric and breast cancers. However, due to their chemical incompatibility, current formulations of 5-FU and LV suffer from limitations in their safety, tolerability, effectiveness and pharmacological compatibility. These disadvantages contribute to limited treatment response rates, unpleasant side effects and toxicities, and a reduced quality of life experienced by cancer patients. Deflexifol™ has been designed to address these limitations through co-administration of the two agents with clinically demonstrated improvements in safety and tolerability and the potential to offer superior anti-tumour efficacy, better quality of life, and overall enhanced clinical benefit for cancer patients.
FivepHusion is developing Deflexifol™ via the FDA 505(b)(2) and EMA Article 10b regulatory pathways as a bioequivalent, chemotherapy replacement of sub-optimal standard of care formulations of 5-FU and LV for the treatment of metastatic colorectal cancer, and other tumours with a projected global incidence of greater than 6 million patients. Deflexifol™ is also being developed as a new therapy for cancers with high unmet medical need, including paediatric ependymoma; a rare and deadly brain cancer which afflicts very young children. A phase 1b clinical trial investigating Deflexifol™ as a treatment for paediatric ependymoma and other brain cancers is ongoing.
Deflexifol™ is a trademark of FivepHusion.
Forward-Looking Statements
This announcement (and any attachments) may contain certain forward-looking statements that are based on any number of assumptions and estimates which may prove incorrect and relate to circumstances and events that may not take place. Forward-looking statements involve known and unknown risks, uncertainties, and other factors (such as significant business, economic and competitive uncertainties and contingencies, and regulatory and clinical development risks and uncertainties) which may cause the actual future plans, results or the performance of FivepHusion and its drug Deflexifol™ to differ materially from the plans, results or performance expressed or implied by such forward-looking statements. Past performance is not a reliable indicator of future performance. There can be no assurance that any forward-looking statements will be realised. FivepHusion does not make any representation or give any warranty as to the likelihood of achievement or reasonableness of any forward-looking statements.