Australian company FivepHusion has announced what it describes as "important progress" towards developing its chemotherapy candidate Deflexifol.
It has announced a collaboration with the University of South Australia (UniSA) for bioanalytical methods development, pharmacokinetic analyses and clinical trial management for the ongoing FP101A phase Ib/IIa clinical trial and future Deflexifol trials.
There was also a poster presentation for UniSA Deflexifol pharmacokinetic modelling and patient data at the APSA-ASCEPT 2022 Joint Conference, a successful capital raise, and the receipt of an R&D tax incentive payment from the Australian Tax Office and Export Market Development Grant from Austrade.
Deflexifol is an optimised all-in-one formulation of the chemotherapeutic agent 5-FU and its biomodulator LV for treating solid tumours.
FivepHusion said the Deflexifol formulation aims to address limitations with current treatments by optimising co-administration of 5-FU and LV at a physiological pH to enhance patient treatment via greater safety, tolerability and potentially superior efficacy.
FivepHusion CEO and managing director Dr Christian Toouli said, “We are delighted to partner with Associate Professor Stephanie Reuter Lange and her team at the University of South Australia. This collaboration brings FivepHusion deep expertise and capabilities in bioanalytics, pharmacokinetics modelling and clinical trials management as we seek to expedite the development of Deflexifol to registration and commercialisation.”
Associate Professor Stephanie Reuter Lange said, “5FU, in combination with leucovorin, remains a fundamental component of many efficacious chemotherapy regimens for patients with solid tumours. Yet, due to physical incompatibility issues, standard administration schedules involve sequential administration of these agents.
"Given the importance of leucovorin in modulating 5-FU activity, simultaneous administration of 5-FU and leucovorin via the Deflexifol formulation is expected to enhance anti-tumour effects. We are looking forward to collaborating with FivepHusion on the development of this important enhanced formulation of an important chemotherapeutic drug.”
FivepHusion also announced the completion of a capital raise supported by existing shareholders and a number of new investors.
"In total, the raising eclipsed the Board’s funding goal by more than 30%," said the company, adding, "This capital will be deployed to progress development of Deflexifol, including completion of the ongoing FP101A clinical trial and regulatory engagement with the US FDA."
"Having completed this internal raising, FivepHusion is in talks with prospective external investors regarding funding the development activities required to position FivepHusion for a phase III registration trial for Deflexifol in metastatic colorectal cancer," it added.