FivepHusion today announces the establishment of an independent, expert Clinical Advisory Board (CAB) comprising some of Australia’s leading clinical experts in oncology and pharmacology. The board will advise and guide our company on the ongoing development of Deflexifol™, an optimised formulation of the chemotherapeutic agents 5-fluoruracil (5-FU) and leucovorin (LV) for the treatment of solid tumours.

The CAB will initially be tasked with assisting FivepHusion to refine the design of our global phase III registration trial for 1st line unresectable metastatic colorectal cancer; optimising the clinical strategy to secure regulatory approval and to generate the data set which oncologists would wish to see to use Deflexifol™ as a replacement for currently used sub-optimal formulations of 5-FU and LV in solid tumour therapy. FivepHusion intends to finalise the phase III trial design during H1 2022, followed by consultations with, and regulatory submissions to, global regulatory agencies to facilitate initiation of a global phase III clinical study.

The initial cohort of independent experts representing the core members of the FivepHusion Clinical Advisory Board are:

  • Professor Stephen Clarke OAM (CAB Chairman) – Professor of Medicine, University of Sydney (USyd); Senior Staff Specialist in Medical Oncology, Royal North Shore Hospital; Chief Medical Officer, Medical Oncology, Genesis Care
  • Professor John Simes AO – Senior Principal Research Fellow and Senior Associate Director, NHMRC Clinical Trials Centre, USyd; Professor of Clinical Epidemiology, NHMRC Clinical Trials Centre, Sydney Medical School, USyd; Medical Oncologist, Chris O’Brien Lifehouse and Royal Prince Alfred Hospital, Sydney
  • Professor Andrew McLachlan AM – Head of School and Dean, Sydney Pharmacy School, Faculty of Medicine and Health, USyd
  • Professor John Zalcberg OAM – Professor of Medicine, Head, Cancer Research Program, School of Public Health and Preventive Medicine, Monash University and Director, Division of Cancer Medicine, at the Peter MacCallum Cancer Centre for 17 years prior to taking up the position at Monash University

Professor Stephen Clarke, Chairman of the FivepHusion CAB commented, “I am delighted to join the FivepHusion CAB as Chairman and look forward to working with my CAB colleagues and FivepHusion management to optimise Deflexifol™ clinical development. Deflexifol™, a promising new drug for the treatment of metastatic colorectal cancer and other solid tumours, could be shown to provide substantial clinical benefits to cancer patients in the future.”

Dr Christian Toouli, CEO & Managing Director of FivepHusion remarked, “We are very pleased that such an expert and well-credentialed panel of professionals has agreed to serve on our Clinical Advisory Board. The willingness of these senior clinicians and scientists to contribute their expertise to our clinical program endorses the unmet medical need in metastatic colorectal cancer and other solid tumours, the inadequacy of current 5-FU-based chemotherapy, and the therapeutic potential of Deflexifol™ as an optimised chemotherapeutic formulation.”

For more information, please contact:

Dr Christian Toouli
CEO & Managing Director
c.toouli@fivephusion.com

Announcement authorised by the Board of Directors of FivepHusion

About FivepHusion and Deflexifol™

Throughout our lives, each of us will either experience the trauma of cancer first-hand, or through the experiences of a family member or friend. Unfortunately, often the chemotherapy used to treat cancer has limited therapeutic benefits, whilst causing a significant side effect burden and serious impact on quality of life.

FivepHusion is a late stage, globally focused, biotechnology company, founded by clinicians, scientists and biotechnology executives whose purpose is to optimise chemotherapy to improve patient treatment and quality of life. We are developing Deflexifol™, a proprietary, novel, optimised formulation of the chemotherapeutic agents 5-fluorouracil (5-FU) and its biomodulator leucovorin (LV), for the treatment of solid tumours. Current formulations of 5-FU and LV are the standard of care for modern treatment of metastatic colorectal cancer (mCRC) and are also frequently utilised to treat a range of other highly incident tumours, including colorectal, breast, gastric, head & neck and pancreatic cancers. However, current formulations of 5-FU and LV suffer from limitations in their safety, tolerability, effectiveness and pharmacological compatibility. These disadvantages contribute to the limited treatment response rates, unpleasant side effects and toxicities, and the reduced quality of life experienced by cancer patients. Deflexifol™ has been designed to address these limitations; optimising the concurrent administration of these chemotherapeutic agents in an all-in-one formulation, with clinically demonstrated improved 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™ as a bioequivalent, chemotherapy replacement of sub-optimal standard of care formulations of 5-FU and LV for the treatment of mCRC and other tumours with a projected global incidence of greater than 6 million patients, and as a new therapy for cancers with high unmet medical need, such as paediatric ependymoma; a rare and deadly brain cancer which afflicts very young children.

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.