UniSA is helping develop a better chemotherapy drug for enhanced patient outcomes

The problem

Fluorouracil (5FU) is a common chemotherapy drug used to fight many cancers, including solid tumours. The drug is commonly administered alongside a biomodulator known as leucovorin which enhances the cytotoxic – or ‘cancer-killing’ – effects of 5FU. The combination of 5FU and leucovorin remains a fundamental component of many efficacious chemotherapy regimens for patients with solid tumours.

However, these two drugs cannot be administered together at one time. As such, it is estimated that the combined benefit of 5FU and leucovorin only occurs for approximately 4% of the entire treatment period. This means patient outcomes are far from optimal. Strategies to increase co-exposure of 5FU and leucovorin are therefore needed to enhance anti-tumour effects.

The solution

University of South Australia (UniSA) researcher, Associate Professor Stephanie Reuter Lange, has partnered with Australian biotechnology company FivepHusion to develop an all-in-one reformulation of 5FU and leucovorin, named Deflexifol™.

This reformulation allows for simultaneous administration of both drugs and enables 100% co-exposure of these agents.

With expertise in drug development and clinical pharmacokinetics, Assoc Prof Reuter Lange and her team have worked with FivepHusion to leverage the company’s existing data to design FivepHusion’s upcoming clinical trials to progress Deflexifol™ towards regulatory approval.

CEO and Managing Director of FivepHusion, Dr Christian Toouli, says his company is “delighted to partner with Assoc Prof Stephanie Reuter Lange and her team at the University of South Australia.

“This collaboration has provided FivepHusion with UniSA’s deep expertise and capabilities in bioanalytics, pharmacokinetic modelling and clinical trials management as we seek to expedite the development of Deflexifol™ to registration and commercialisation," Dr Toouli says.

Assoc Prof Reuter Lange says the UniSA partnership with FivepHusion is a testament to what can be achieved when industry partners with researchers.

“Given the importance of leucovorin in modulating 5FU activity, simultaneous administration of 5FU and leucovorin via the Deflexifol™ formulation represents a significant advancement in anti-cancer treatment, and an opportunity for improved care of patients.

“The important information we’ve been able to provide FivepHusion has been pivotal in our discussions with the US Food and Drug Administration (FDA) and instrumental in the FDA’s confirmation that Deflexifol™ can be registered under an accelerated regulatory path.”

Caption: Fluorouracil (5FU) is a chemotherapy drug often combined with leucovorin to enhance its effects. However, they can't be given together, limiting treatment success. To solve this, UniSA and FivepHusion are developing a new formulation that allows both drugs to be administered at once.

The first of two key studies to be conducted in the Deflexifol™ development program have now received Human Research Ethics Committee (HREC) approval and is expected to commence in late 2024.

Dr Toouli says the collaboration with UniSA has helped progress the new drug towards further regulatory approval.

“Our collaboration with UniSA, led by Associate Professor Stephanie Reuter Lange, has contributed valuable advice for our clinical trial strategy,” Dr Toouli says.

“The expertise and contribution of Assoc Prof Reuter Lange has been extremely beneficial in our interactions with both ethical and regulatory agencies,” Dr Toouli says.

“This allowed us to expedite the development of Deflexifol™ toward registration and commercialisation.

“UniSA’s guidance has also enabled us to optimise our clinical development plans to meet the FDA’s requirements for an accelerated regulatory path.”

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