TIDMAGL
Angle PLC
20 September 2021
For immediate release 20 September 2021
ANGLE plc ("the Company")
PARSORTIX SYSTEM ENABLES GENE EXPRESSION ANALYSIS IN METASTATIC
PROSTATE CANCER PATIENTS
Parsortix able to isolate CTCs in 80% of patients providing
access to tumour material for gene expression analysis when tissue
biopsy not feasible
Longitudinal patient monitoring using Parsortix showed reduction
in CTCs with patient drug response providing further evidence to
support the use of Parsortix in pharma services business
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that the Medical University of
Innsbruck, Austria has published results from a study in metastatic
prostate cancer (mPCa) patients. A key aim of this study was to
demonstrate the ability to analyse gene expression in circulating
tumour cells (CTCs), which may help guide treatment decision-making
for a diverse range of mPCa patients with differing tumour burdens
and various prior therapies.
Despite the study not investigating mesenchymal CTCs (those that
have been through EMT, the epithelial-mesenchymal transition known
to occur during disease progression), and the capture of which is a
particular strength of the Parsortix system, epithelial CTCs were
recovered using the Parsortix system which could then be analysed
for gene expression in 80% of patients.
Longitudinal monitoring of one patient was undertaken using the
Parsortix system, with five blood draws over a six-month period,
and it was notable that the presence of CTCs declined from around
30 CTCs in a 7.5ml blood sample to zero when that patient responded
positively to therapy. This finding further supports the potential
for use of the Parsortix system to monitor drug response in cancer
drug trials which are assessing patients before, during and after
therapy and the researchers believe that further studies to monitor
drug response in a larger cohort of patients are warranted.
Longitudinal analysis cannot be routinely undertaken using tissue
biopsy during clinical trials as repeat samples are generally not
available and is the basis of ANGLE's pharma services business
established earlier this year.
It is estimated that 1 in 8 men will be diagnosed with prostate
cancer in their lifetime. There are an estimated 3.2 million men
living with prostate cancer in the United States alone, with
250,000 new cases anticipated in 2021.
Since tumour tissue material is generally unavailable in
metastatic prostate cancer, CTCs provide non-invasive and
repeatable access to tumour cells and, in accordance with the
National Comprehensive Cancer Network (NCCN) guidelines, allow for
biomarker testing at all stages of prostate cancer to inform
targeted treatment. This study and others, highlight the utility of
CTCs in analysing molecular changes in tumour cells in prostate
cancer to inform personalised therapy decisions.
The research has been published as a peer-reviewed publication
in the journal Biomedicines and may be accessed via
https://angleplc.com/library/publications/ .
Prof Iris E. Eder from the Department of Urology, Medical
University Innsbruck, Austria, commented:
"Since tissue material is often lacking in metastatic prostate
cancer (mPCa), there is increasing interest in using liquid
biopsies to inform treatment decisions and monitor therapy
response. Our study is focused on the expression of a limited gene
panel in an unselected, very heterogeneous cohort of patient
samples, who are representative of prostate cancer patients found
routinely in a clinical setting. Further studies are now under way
to clearly define the molecular expression pattern of CTCs through
RNA sequencing in order to obtain a gene panel in a defined cohort
of patients with mPCa, which may be of clinical prognostic
value."
ANGLE Founder and Chief Executive, Andrew Newland, said:
"The study demonstrated gene expression analysis of the cancer
cells, in this case using an established molecular analysis
technique, qPCR, which is used widely with tissue biopsy. This
study therefore provides further evidence of the capability of the
Parsortix system to provide cancer cells for analysis from a simple
blood test when tissue biopsy is not feasible, with the potential
to guide future treatment decisions.
The study adds to the body of evidence for the Parsortix system
in relation to prostate cancer, which is the focus for ANGLE's
first large scale pharma services contract and continues to be a
key area for ANGLE's development efforts following our recent
capital raise."
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Andrew Holder, Head of Investor Relations
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon
Hicks, Teddy Whiley
ECM - Alice Lane, Sunila de Silva +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks +44 (0) 203 705 9330
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (United States) +1 (212) 850 5624
For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/glossary/
Notes for editors
About ANGLE plc www.angleplc.com
ANGLE is a world leading liquid biopsy company with
sample-to-answer solutions. ANGLE's proven patent protected
platforms include a circulating tumour cell (CTC) harvesting
technology and a downstream analysis system for cost effective,
highly multiplexed analysis of nucleic acids and proteins.
ANGLE's cell separation technology is called the Parsortix(R)
system, and it enables a liquid biopsy (a simple blood test) to be
used to provide the cells of interest to the user in a format
suitable for multiple types of downstream analyses. The system is
based on a microfluidic device that captures cells based on a
combination of their size and compressibility. The system is
epitope independent and can capture all types of CTCs as well as
CTC clusters in a viable form (alive). CTCs enable the complete
picture of a cancer to be seen as being an intact cell they allow
DNA, RNA and protein analysis and may provide comparable analysis
to a tissue biopsy. Because CTC analysis is a non-invasive process,
unlike tissue biopsy, it can be repeated as often as needed. This
is important because cancer develops and changes over time and
there is a clear medical need for up-to-date information on the
status of a patient's tumour. In addition, the live CTCs harvested
by the Parsortix system can be cultured, which offers the potential
for testing tumour response to drugs outside the patient.
The Parsortix technology is the subject of 26 granted patents in
Europe, the United States, China, Australia, Canada, India, Japan
and Mexico with three extensive families of patents are being
progressed worldwide.
The Parsortix system has a CE Mark in Europe for the indicated
use and, in the United States, a De Novo Submission has been made
to FDA for the Parsortix(R) PC1 system seeking FDA clearance with
Class II Classification for use with metastatic breast cancer
patients. FDA clearance is seen as the global standard. ANGLE is
seeking to be the first ever FDA cleared system for harvesting CTCs
for subsequent analysis.
ANGLE has also completed two separate 200 subject clinical
studies under a program designed to develop an ovarian cancer
pelvic mass triage test, with the results showing best in class
accuracy (AUC-ROC) of 95.1%. The pelvic mass triage assay has
undergone further refinement and optimisation and is currently in
the process of a 200-patient clinical verification study.
ANGLE's technology for the multiplex evaluation of proteins and
nucleic acids of all types is called the HyCEAD(TM) Ziplex(R)
platform and is based on a patented flow through array technology.
It provides for low cost, highly multiplexed, rapid and sensitive
capture of targets from a wide variety of sample types. A
proprietary chemistry approach (the HyCEAD method) allows for the
capture and amplification of over 100 biomarkers simultaneously in
a single reaction. The HyCEAD Ziplex system is extremely sensitive
and is ideal for measuring gene expression and other markers
directly from Parsortix harvests and was used in the ovarian cancer
pelvic mass triage test to achieve best in class accuracy (AUC-ROC)
of 95.1%.
ANGLE's proprietary technologies can be combined to provide
automated, sample-to-answer results in both centralised laboratory
and point-of-use cartridge formats.
ANGLE has established formal collaborations with world-class
cancer centres and major corporates such as Abbott, Philips and
QIAGEN, and works closely with leading CTC translational research
customers. These Key Opinion Leaders (KOLs) are working to identify
applications with medical utility (clear benefit to patients), and
to secure clinical data that demonstrates that utility in patient
studies. The body of evidence as to the benefits of the Parsortix
system is growing rapidly from our own clinical studies in
metastatic breast cancer and ovarian cancer and also from KOLs with
48 peer-reviewed publications and numerous publicly available
posters, available on our website.
ANGLE has established clinical services laboratories in the UK
and USA to accelerate commercialisation of the Parsortix system and
act as demonstrators to support product development. The
laboratories offer services to pharmaceutical and biotech customers
for use of the Parsortix system in cancer drug trials and, once the
laboratories are accredited, and tests validated, will provide
Laboratory Developed Tests (LDTs) for patient management.
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