FivepHusion today announces an important regulatory milestone associated with the development of Deflexifol™, an enhanced chemotherapeutic formulation for patients with advanced solid tumours.
  • A successful Type C Meeting interaction with the US FDA which provided valuable feedback on the Deflexifol™ clinical development, Chemistry, Manufacturing and Controls (CMC) and regulatory paths for metastatic colorectal cancer (mCRC)
  • Valuable advice on the design of the next phase Ib/IIa clinical trial (FP101B) intended to confirm the Deflexifol™ dose for phase III development, when combined with oxaliplatin and bevacizumab
  • Deflexifol™ able to be immediately developed for 1st line mCRC patients – no requirement to first seek approval in later lines of treatment
  • Only one successfully conducted phase III pivotal trial required to support registration
  • Confirmation of the FDA 505(b)(2) regulatory path for registration in mCRC
  • No concerns raised about the proposed Deflexifol™ CMC pathway to registration

FivepHusion is developing Deflexifol™, an optimised all-in-one formulation of the chemotherapeutic agent 5-FU and its biomodulator LV for the treatment of solid tumours. The Deflexifol™ formulation addresses significant limitations with current treatment, offering a “best in class” therapy by optimising co-administration of 5-FU and LV at a physiological pH to enhance patient treatment via greater safety, tolerability and  superior efficacy.

In December 2022, FivepHusion, together with its global regulatory consultants PharmaLex, engaged with the US Food and Drug Administration (FDA) in a Type C meeting to seek feedback on the company’s proposed clinical development program, CMC and regulatory paths for Deflexifol™. The FDA provided constructive feedback on the design of the planned next clinical trial, FP101B, a dose-ranging clinical study designed to confirm the appropriate Deflexifol™ dose to take forward into a pivotal phase III trial in mCRC patients. The Agency confirmed that Deflexifol™ can be developed in 1st line metastatic colorectal cancer patients, and that only one successfully conducted phase III trial should be sufficient for registration of Deflexifol™. The FDA stated no concerns about the FivepHusion proposed CMC pathway and also confirmed that registration of Deflexifol™ should be pursued via the 505(b)(2) regulatory path.

FivepHusion Executive Director, Dr Bill Ketelbey said, “The FDA has provided very valuable feedback on the design elements for our future clinical studies. These insights allow FivepHusion to optimise the Deflexifol clinical development program to generate the data set necessary to achieve registration of Deflexifol as an enhanced 5-FU and LV formulation for the treatment of 1st line metastatic colorectal cancer patients.”

FivepHusion CEO, Dr Christian Toouli commented, “This strategically important interaction with the FDA has confirmed our understanding of the clinical development, CMC and regulatory paths for Deflexifol. We are delighted that the Agency confirmed their requirement for one successfully conducted phase III trial and that FivepHusion can develop Deflexifol via the accelerated and de-risked 505(b)(2) regulatory path for our chosen patient population.”

For more information, please contact:

Dr Christian Toouli
CEO & Managing Director
c.toouli@fivephusion.com

Announcement authorised by the Board of Directors of FivepHusion.

About FivepHusion and Deflexifol™

Throughout our lives, each of us will experience the trauma of cancer first-hand, or through the experiences of family or friends. Unfortunately, the chemotherapy used to treat cancer often has limited therapeutic benefits, with a significant side effect burden and serious impact on quality of life.

FivepHusion (www.fivephusion.com) is a late stage, globally focused biotechnology company whose purpose is to optimise chemotherapy to improve patient treatment and quality of life. We are developing Deflexifol™, a proprietary, novel, and optimised physiological pH formulation of the chemotherapeutic agent 5-fluorouracil (5-FU) and its biomodulator leucovorin (LV) for the treatment of solid tumours. Current formulations of 5-FU and LV are the standard of care for modern treatment of metastatic colorectal cancer (mCRC) and are also frequently utilised to treat a range of other highly incident tumours, including colorectal, breast, gastric, head & neck and pancreatic cancers. However, 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, 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™ as a bioequivalent, chemotherapy replacement of sub-optimal standard of care formulations of 5-FU and LV for the treatment of mCRC, 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, such as 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.