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 suboptimal 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-credentialled 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.”