FivepHusion today announces important progress associated with the development of Deflexifol™, an enhanced chemotherapeutic formulation for patients with advanced solid tumours.
  • Strategic collaboration with the University of South Australia (UniSA) for bioanalytical methods development, pharmacokinetic (PK) analyses and clinical trials management for the ongoing FP101A phase Ib/IIa clinical trial and future Deflexifol™ trials
  • Poster presentation for UniSA Deflexifol™ pharmacokinetic modelling and patient data at the APSA-ASCEPT 2022 Joint Conference
  • Successful capital raising over-subscribed
  • Receipt of the R&D tax incentive payment from the Australian Tax Office and Export Market Development Grant from Austrade

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.

UniSA Strategic Collaboration and APSA-ASCEPT 2022 Joint Conference Poster Presentation

FivepHusion has partnered with the University of South Australia (UniSA) to undertake bioanalytical methods development, pharmacokinetic (PK) analyses and clinical trials management for ongoing and future clinical trials of Deflexifol™. The collaboration includes the ongoing FP101A phase Ib/IIa clinical trial (ACTRN12619001533189), a dose ranging study designed to confirm the PK, safety, tolerability and maximum tolerated dose of Deflexifol™ when delivered in a schedule mimicking the standard of care (SOC) “de Gramont” regimen, in end-stage solid tumour cancer patients. The UniSA team is led by Associate Professor Stephanie Reuter-Lange, Department of Clinical Pharmacology, an expert in clinical pharmacokinetics focused on researching the optimal use of medications, such as 5-FU.

Dr Christian Toouli, CEO and Managing Director of FivepHusion 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 commented, “5-FU, 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 expectedto 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.”

Dr Tahlia Meola, UniSA Project Manager for the FivepHusion UniSA collaboration, will present 5-FU, LV and Deflexifol™ PK modelling and patient PK data as part of a poster presentation at the APSA-ASCEPT 2022 Joint Conference (Perth, November 29th November – 2nd December 2022). The clinical data was derived from the FP101A clinical trial and generated in collaboration with the laboratory of Professor Stephen Ackland, Faculty of Health, University of Newcastle. This poster provides preliminary clinical evidence to support the enhanced duration and extent of 5-FU and leucovorin co-exposure with Deflexifol™ treatment, which is anticipated to maximise clinical activity and enhance anti-tumour effect when compared to current SOC treatment regimens.

Successful Capital Raising Over-Subscribed

FivepHusion is very pleased to announce a successful capital raising, having received strong investment support from the Board, existing shareholders and a number of new investors. In total, the raising eclipsed the Board’s funding goal by more than 30%. 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.

Non-Dilutive Capital: R&D Tax Incentive and Export Market Development Grant

FivepHusion has received a FY21/22 R&D Tax Incentive (RDTI) payment from the Australian Taxation Office as a result of a successful RDTI submission claiming Australian and international research and development costs associated with Deflexifol™ non-clinical and clinical development. In September, the company also received a payment from Austrade for the company’s FY21/22 export related expenses, including patent prosecution and business development costs.

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.