8th January 2025
Physiomics plc
("Physiomics" or the "Company")
Clinical Trial
Approval
Physiomics plc (AIM: PYC), a leading
mathematical modelling, data science and biostatistics company
supporting the development of new therapeutics and personalised
medicine solutions, is delighted to announce that the Innovate UK
Funded project called PREDICT-ONC has now received both regulatory
and ethical approval.
The Company's personalised dosing software has
been developed primarily with grant funding from UK bodies,
including £68,000 from Innovate UK (March 2018), £150,000 from the
National Institute for Head and Care Research to fund the PARTNER
study (March 2020) and more recently £137,376 from Innovate UK and
The Office for Life Sciences to fund the PREDICT-ONC study
(announced in November 2023).
The software was initially developed to support
clinicians make cancer chemotherapy (docetaxel) dosing decisions,
helping to optimise dosing for individual patients to improve
patient outcomes. However, as a result of the PARTNER study
(completed in January 2023), a second utility was observed, in that
the software could be used to support the dosing of an expensive
biological drug GCSF. This drug is routinely used in many countries
to counteract the toxic effect chemotherapy has on patient's white
blood cells - a condition known as neutropenia.
The aim of this latest Innovate UK funded grant,
"Precision Risk Evaluation and G-CSF Dosing for
Chemotherapy-Induced Neutropenia Tool", known as PREDICT-ONC
("Project"), is to further develop and evaluate the software's
ability to predict GCSF dosing. The Project, being run in
partnership with Beyond Blood Diagnostics Limited ("Beyond Blood
Diagnostics") and Blackpool Teaching Hospitals NHS Foundation Trust
("Blackpool Teaching Hospitals") will recruit breast cancer
patients undergoing standard of care GCSF treatment onto an
observational clinical trial in order to predict and measure the
effect treatment has on neutropenia. The data resulting from this
trial will support the refinement and evaluation of the
software.
Although, due to reasons outside of our control,
the approval for the PREDICT-ONC observational trial has been
somewhat delayed from the initial target of summer 2024, the
project team believes that recruitment can start imminently and the
overall impact on completion timelines will be kept to the minimum
(projected for Oct-Dec 2025).
Dr Peter
Sargent, CEO, 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. However, due
to the hard work of the project team, including recruitment of a
research nurse and proactive identification of potential patients,
we predict that these delays will have minimal impact on the
overall timelines and final readout of the project. We at
Physiomics are excited to start receiving the data generated from
this trial, so we can continue development of our Personalised
Dosing Software".
Enquiries:
Physiomics
plc
Dr Peter Sargent, CEO
+44 (0)1235 841575
Hybridan LLP
(Broker)
Claire Louise Noyce
+44 (0) 203 764 2341
Strand Hanson
Ltd (NOMAD)
James Dance & James Bellman
+44 (0)20 7409 3494
Notes to
Editor
About Physiomics
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. Our approach is to help derive insight from all relevant
and often disparate data in order to de-risk decision making and
optimise research design across discovery, pre-clinical and
clinical studies. Through use of cutting-edge computational tools,
bespoke models and our 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.
