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RCS - Physiomics PLC - Clinical Trial Approval

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RNS Number : 5717S  Physiomics PLC  08 January 2025

8(th) 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.  

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