FivepHusion has announced the establishment of an independent, expert clinical advisory board (CAB) comprising some of Australia’s leading clinical experts in oncology and pharmacology.
The company said the board will advise and guide the ongoing development of Deflexifol. This is 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 its global phase 3 registration trial for unresectable metastatic colorectal cancer, optimising the clinical strategy to secure regulatory approval and generating the data set to support the use of Deflexifol as a replacement for currently used suboptimal formulations of 5-FU and LV in solid tumour therapy.
The company said it intends to finalise the trial design during the first half of the calendar year 2022.
The initial cohort of independent experts on the CAB are Professor Stephen Clarke OAM (chairman), Professor John Simes AO, Professor Andrew McLachlan AM and Professor John Zalcberg OAM.
Professor Clarke said, “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.”
FivepHusion CEO and managing director Dr Christian Toouliadded, “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.”