TIDMPYC
RNS Number : 0107M
Physiomics PLC
09 January 2023
9 January 2023
Physiomics plc
("Physiomics" or "the Company")
Completion of PARTNER study
Physiomics plc (AIM: PYC), the oncology consultancy using
mathematical models to support the development of cancer treatment
regimens and personalised medicine solutions, is pleased to
announce the successful completion of its PARTNER study which was
funded by a GBP150k "Connect" award from the National Institute for
Health Research ("NIHR") Invention for Innovation ("i4i") programme
(originally announced in March 2020).
HIGHLIGHTS
-- The NIHR funded PARTNER study builds on work completed under two previous grants
-- PARTNER data is being used to support development of a
personalised dosing tool for docetaxel in prostate cancer
-- Analysis of trial data confirms the ability of the tool to
predict levels and timing of episodes of low white blood cell count
associated with use of docetaxel
-- Trial data further suggests there is potential for the tool
to be used to predict the effect of GCSF ( granulocyte-colony
stimulating factor) , a drug commonly used to increase white blood
cell count during chemotherapy
-- The tool would be highly synergistic with a device that can
measure blood cells counts in community or out-patient settings and
this will be further explored by Physiomics during the current
quarter
-- Further work is merited to explore the use of the tool in
other settings including haematology and paediatrics
BACKGROUND
The project award, formally titled "Further development of and
evidence generation for a precision dosing tool for optimising
chemotherapy dosing in advanced prostate cancer" built on work
carried out under two previous Innovate UK grants to the Company in
2017 and 2018. Published literature confirms that following the
same administered dose, 2-3 fold variations in blood levels of
docetaxel have been observed between individuals(1) , potentially
leading to a significant number of patients receiving either less
or more of the drug than intended. Titrating dosing to the level of
drug in the blood has been shown to significantly improve patient
survival(2) and toxicity(3) in certain chemotherapy treatments.
However, such precision-dosing techniques typically require costly
additional tests, which restrict their use in clinical
practice.
THE PARTNER STUDY
The majority of the i4i award was used to fund "PARTNER", an
observational trial run by the Portsmouth Technology Trials Unit
("PTTU"). PTTU is a collaboration between Portsmouth Hospitals
University NHS Trust and the University of Portsmouth, specialising
in clinical trials in new healthcare technologies. The trial did
not directly involve the use of the tool itself, but focused on
collecting key data from prostate cancer patients treated with
docetaxel to validate our personalised dosing tool, and in
particular to:
-- Confirm the ability of the tool to predict levels and timing
of episodes of low white blood cells ("neutropaenia") associated
with the use of chemotherapy and which can lead to serious side
effects for patients
-- Explore the tool's potential to predict the effect of GCSF, a
class of drugs commonly used to counteract neutropaenia associated
with chemotherapy
Ethics committee and Health Research Authority (HRA) approval
for the study was received in December 2020, however, due to delays
caused by the COVID pandemic, the first patient was not recruited
until September 2021 and recruitment was therefore extended until
September 2022. At the close of the study, 32 patients had been
recruited which was fewer than originally targeted, nonetheless,
the quality of the data was excellent and, in our view, sufficient
for the purposes noted above.
KEY INSIGHTS GAINED
An initial analysis of the data from the PARTNER study has been
completed. For each patient, data from their first three-week cycle
of docetaxel treatment was used to build a personalised dosing
model. This model was then used to predict the same patient's level
of neutropenia during their second cycle of treatment and this
prediction was compared with actual study data. The model
successfully captured both the extent and the timing of
neutropaenia and hence could form the basis of a tool to help
clinicians make dosing decisions in this disease and, potentially,
other cancers where neutropenia is a feature of treatment. This may
help clinicians avoid unwanted toxicities and ensure that maximum
benefit is obtained by individual patients.
In addition, although the model was not originally designed to
capture the effects of GCSF, a modified version of the model was
used in the same way described above to predict the levels of
neutropenia experienced by patients treated with this drug
alongside docetaxel. It was pleasing to note that while predictions
were not fully consistent with the observed value, there appeared
to be real potential for the model to be used in this alternative
setting. This is important as, by contrast with docetaxel which is
cheap and available in a generic (non-branded) form, GCSF is an
expensive biological product. A model that could inform its use
could potentially be of commercial value.
One of the practical challenges of implementing the dosing tool
specifically for docetaxel in prostate cancer is the need for
patients to come in for 2-3 additional blood tests during their
first cycle of treatment to generate the data needed to develop
their personalised dosing model. A means of easily conducting these
tests at home or in a community setting ("point of care"), might
significantly enhance the potential value of the tool.
NEXT STEPS
There are multiple ways in which the results of the PARTNER
study can be leveraged:
-- Academic dissemination; the insights gained from the PARTNER
study will form the basis of several posters and/or
publications
-- The exploring of solutions for point of care blood testing
that could address the limitation noted above. Physiomics has
already identified a number of technologies in development that
could be the basis for a hardware/ software collaboration
-- Exploring other applications of the tool in settings where
regular attendance at hospital for additional tests is not an
obstacle because it is already required as part of current standard
of care or because the use of the drug requires careful monitoring;
examples could include:
o Paediatric applications where it is important to maintain
certain cell types within strict limits
o Patients with haematological malignancies
o Patients undergoing chemotherapy in combination with
radiotherapy
Dr Jim Millen, CEO commented : "I believe that the PARTNER
study, as the culmination of several years of grant funded work,
offers a significant opportunity for Physiomics to engage in the
emerging personalised dosing space, either alone or in partnership
with other complementary technologies. We'll be actively following
up the areas noted above and will provide an update to shareholders
before the end of Q1 2023."
(1) McLeod, H.L et al, 1998. Evaluation of the linearity of
docetaxel pharmacokinetics. Cancer chemotherapy and pharmacology,
42(2), pp.155-159.
(2) Fang, Luo, et al. Pharmacokinetically guided algorithm of
5-fluorouracil dosing, a reliable strategy of precision
chemotherapy for solid tumors: a meta-analysis. Scientific reports
6 (2016): 25913.
(3) Hénin, Emilie, et al. Revisiting dosing regimen using PK/PD
modeling: the MODEL1 phase I/II trial of docetaxel plus epirubicin
in metastatic breast cancer patients. Breast cancer research and
treatment 156.2 (2016): 331-341.
This announcement is released by Physiomics plc and contains
inside information for the purposes of Article 7 of the Market
Abuse Regulation (EU) 596/2014 (MAR), and is disclosed in
accordance with the Company's obligations under Article 17 of
MAR.
Enquiries:
Physiomics plc
Dr Jim Millen, CEO
+44 (0)1865 784 980
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 (AIM: PYC) is an oncology consultancy using
mathematical models to support the development of cancer treatment
regimens and personalised medicine solutions. The Company's Virtual
Tumour(TM) technology uses computer modelling to predict the
effects of cancer drugs and treatments to improve the success rate
of drug discovery and development projects while reducing time and
cost. The predictive capability of Physiomics' technologies have
been confirmed by over 80 projects, involving over 40 targets and
70 drugs, and has worked with clients such as Merck KGaA, Astellas,
Merck & Co and Bicycle Therapeutics.
About NIHR
The mission of the NIHR is to improve the health and wealth of
the nation through research. We do this by:
-- Funding high quality, timely research that benefits the NHS, public health and social care;
-- Investing in world-class expertise, facilities and a skilled
delivery workforce to translate discoveries into improved
treatments and services;
-- Partnering with patients, service users, carers and
communities, improving the relevance, quality and impact of our
research;
-- Attracting, training and supporting the best researchers to
tackle complex health and social care challenges;
-- Collaborating with other public funders, charities and
industry to help shape a cohesive and globally competitive research
system;
-- Funding applied global health research and training to meet
the needs of the poorest people in low and middle income
countries.
NIHR is funded by the Department of Health and Social Care. Its
work in low and middle income countries is principally funded
through UK Aid from the UK government.
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