FivepHusion, an advanced clinical-stage biotechnology company, today announces that a poster of the most recently completed Deflexifol™ clinical trial was presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco (January 18-20th, 2024).
The FP101A dose-escalation clinical study of Deflexifol™ monotherapy demonstrated that concomitant delivery of 5-fluorouracil (5-FU) and its biomodulator leucovorin via Deflexifol™ is safe and tolerable in solid tumour patients at 5-FU doses up to 40% higher than typically administered by the standard “modified de Gramont” regimen. Disease control was achieved in 69% of evaluable patients, all of whom were end-stage and typically heavily pre-treated, including with prior 5-FU. The poster detailing the study results was presented by the study’s Principal Investigator, Associate Professor Daniel Brungs (Cancer Care Wollongong), who commented:
“The FP101A trial results were well received by oncologists attending the conference. It is pleasing to have the opportunity to discuss the promising Deflexifol clinical results with colleagues at one of the preeminent international conferences focused on gastrointestinal cancer treatments. There is a desperate need for new therapeutic options for the treatment of colorectal cancer and other GI cancers.”
The abstract and poster presentation are available to view online. All conference presentations and published literature relevant to Deflexifol™ can also be found on the FivepHusion website.
After receiving positive FDA Type C guidance on the clinical and regulatory paths for Deflexifol™ development, FivepHusion is now rapidly progressing plans for a follow-on trial of Deflexifol™ in combination with oxaliplatin and bevacizumab in the first-line treatment of unresectable metastatic colorectal cancer. A clinical trial of Deflexifol™ monotherapy in paediatric brain cancers which commenced last year is also progressing as planned.
About FivepHusion
FivepHusion (www.fivepHusion.com) is an advanced clinical-stage, globally focused biotechnology company whose purpose is to optimise chemotherapy to improve patient treatment outcomes and quality of life.
FivepHusion is developing Deflexifol™, a proprietary, novel, and optimised physiological pH formulation to co-administer the chemotherapeutic agent 5-fluorouracil (5-FU) and its biomodulator leucovorin (LV), a drug that significantly enhances 5-FU anti-cancer activity. These drugs are commonly used globally to treat various solid tumours including colorectal, pancreatic, gastric and breast cancers. However, due to their chemical incompatibility, current formulations of 5-FU and LV suffer from limitations in their safety, tolerability, effectiveness and pharmacological compatibility. These disadvantages contribute to limited treatment response rates, unpleasant side effects and toxicities, and a reduced quality of life experienced by cancer patients. Deflexifol™ has been designed to address these limitations through co-administration of the two agents with clinically demonstrated improvements in 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™ via the FDA 505(b)(2) and EMA Article 10b regulatory pathways as a bioequivalent, chemotherapy replacement of sub-optimal standard of care formulations of 5-FU and LV for the treatment of metastatic colorectal cancer, and other tumours with a projected global incidence of greater than 6 million patients. Deflexifol™ is also being developed as a new therapy for cancers with high unmet medical need, including 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.