FivepHusion has again demonstrated the potential for its flagship Deflexifol™ to revolutionise the standard of care in 5-FU chemotherapy, with a newly completed dose-escalation clinical study highlighting the superior safety and tolerability of Deflexifol™ over traditional chemotherapy formulations.
The results come hot on the heels of the Company securing an international partnership with financial healthcare advisory firm Tree Hill Partners and leading biopharmaceutical solutions organisation Syneos Health to aid in the development and commercialisation of Deflexifol™, with the drug primed to solve a decades-long problem with current 5FU chemotherapy practice and set to be developed as the new Gold Standard of Care™.
Acing the test
The clinical study was designed to confirm the pharmacokinetics (PK), safety, tolerability and maximum tolerated dose (MTD) of Deflexifol™ by administering the drug to mimic the standard of care (SOC) ‘modified de Gramont’ regimen which is typically utilised around the world to treat solid tumours. Deflexifol was administered to treat nineteen end-stage patients with a variety of tumours including metastatic colorectal cancer, and breast, gastric and pancreatic cancers.
The trial once again reaffirmed the enhanced tolerability of Deflexifol™ compared to standard 5-FU and leucovorin (LV) formulations, with its MTD delivering a dose equivalent of ~40 per cent more 5-FU than is typically administered in clinical practice.
Further demonstrating the safety and tolerability of Deflexifol™, many patients opted to extend their treatment beyond the initial four cycles required for the study, with a significant number of patients receiving more than ten treatment cycles. This serves as a testament to the potential of Deflexifol™ to deliver a tolerable therapy that enhances the quality of life beyond what is typically observed with conventional 5-FU chemotherapy formulations.
Pharmacokinetic data from the study confirmed that 5-FU and LV co-formulated in Deflexifol™ is bioequivalent to traditional formulations used in standard of care, giving FivepHusion the opportunity to accelerate the development of Deflexifol through de-risked regulatory routes such as the US Food & Drug Administration’s (FDA) 505(b)(2). This was re-confirmed at a meeting with the FDA in December 2022.
A New Backbone for Chemotherapy
The study showcased Deflexifol™’s superior safety and tolerability, while also demonstrating its potential to effectively treat patients who had previously failed standard-of-care 5-FU therapy. Efficacy data reported an investigator-determined disease control rate of 69% among evaluable patients, including in those patients who had previously failed multiple treatment regimens.
Results from the latest study echo those of the previous trial of Deflexifol™, where 40 end-stage cancer patients were treated. Similar to the earlier trial, this study also showcased improved safety, tolerability, and efficacy. Treating oncologists observed positive responses in patients whose tumours had ceased responding to 5-FU therapy.
The Company said that with a cumulative 59 patients now treated, Deflexifol™ has demonstrated its potential as a promising new chemotherapy for the treatment of metastatic colorectal cancer and other solid tumours.
“The FP101A clinical trial has re-confirmed the safety and tolerability of Deflexifol™ at high doses of 5-FU in end-stage solid tumour patients. Pleasingly, we have also observed stable disease and partial response, indicative of potentially superior efficacy provided by the Deflexifol™ formulation,” Associate Professor Daniel Brungs, Cancer Care Wollongong, Principal Investigator for FP101A said.