Physiomics plc has announced that its PREDICT-ONC (Precision Risk Evaluation and G-CSF Dosing for Chemotherapy-Induced Neutropenia Tool) project has received both regulatory and ethical approval, allowing the company to proceed with its observational clinical trial. The project, which is being run in partnership with Beyond Blood Diagnostics Limited and Blackpool Teaching Hospitals NHS Foundation Trust, aims to refine and evaluate software designed to personalize chemotherapy dosing and manage chemotherapy-induced neutropenia.
The PREDICT-ONC project received a grant of £137,376 from Innovate UK and The Office for Life Sciences. The core of the project is a software initially developed to assist clinicians in tailoring docetaxel chemotherapy dosing. Subsequent studies, including the PARTNER trial completed in January 2023, revealed the software's utility in dosing granulocyte colony-stimulating factor (GCSF), a biological drug used to counteract neutropenia – a condition characterized by reduced white blood cell counts caused by chemotherapy.
The observational clinical trial will recruit breast cancer patients undergoing standard GCSF treatment at Blackpool Teaching Hospitals NHS Foundation Trust. The trial will measure the effects of treatment on neutropenia, generating data to enhance the software's predictive capabilities. The data resulting from this trial will support the refinement and evaluation of the software.
Impact of Approval and Future Plans
Dr. Peter Sargent, CEO of Physiomics, commented, "Physiomics and our partners are thrilled to have now obtained approval to proceed with the PREDICT-ONC observational trial. We had initially planned to start this trial last summer, but due to delays in the approval process that were out of our hands, approval has only now been obtained." Despite the delays, Dr. Sargent anticipates minimal impact on the project's overall timeline due to the team's proactive efforts, including the recruitment of a research nurse and identification of potential patients. The trial's completion is projected for October-December 2025.
Addressing Chemotherapy-Induced Neutropenia
Chemotherapy-induced neutropenia is a common and potentially serious side effect of cancer treatment, increasing the risk of infection and potentially leading to dose reductions or treatment delays. GCSF is routinely administered to stimulate the production of white blood cells and reduce the duration and severity of neutropenia. However, GCSF is an expensive biological drug, and optimizing its dosing is crucial for both patient outcomes and cost-effectiveness.
The PREDICT-ONC project seeks to address this need by developing a tool that can predict the optimal GCSF dose for individual patients, potentially improving patient outcomes and reducing healthcare costs. The software leverages mathematical modelling, data science, and biostatistics to analyze patient-specific data and predict the risk of neutropenia and the appropriate GCSF dose.
Physiomics' Broader Strategy
Physiomics plc combines expertise across Modelling & Simulation, Biostatistics, Data Science and Bioinformatics, together with deep biology expertise, to help biotech and pharma companies streamline their drug development journeys. Through use of cutting-edge computational tools, bespoke models and their proprietary Virtual Tumour technology, the Physiomics team has informed the development of over 100 commercial projects, with over 125 targets and drugs modelled. Clients include Merck KGaA, Astellas, Bicycle Therapeutics, Numab Therapeutics & CRUK.
