TIDMAGL
Angle PLC
09 August 2021
For immediate release 09 August 2021
ANGLE plc ("the Company")
PUBLICATION HIGHLIGHTS EASE OF USE AND SUPERIOR PERFORMANCE OF
PARSORTIX SYSTEM IN HARVESTING CTCs FROM METASTATIC BREAST CANCER
PATIENTS
Quantity, purity and quality of CTCs captured using the
Parsortix system shown to be superior to an alternative
antibody-based approach
Study supports integration of the Parsortix system into
histology laboratories for routine clinical use
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that the Institute of Oncology,
Ljubljana, Slovenia has published favourable results from a
preliminary study in metastatic breast cancer (MBC) patients. The
study compared ANGLE's Parsortix(R) system to an alternative
antibody-based approach for the isolation of circulating tumour
cells (CTCs) to determine whether these systems could be integrated
into routine laboratory use.
For the purpose of this research, thirty MBC patients donated
two 10mL blood samples, which were processed in parallel by both
systems. CTCs were identified by their morphology (as opposed to
biomarkers) using light microscopy which is universally available
in pathology departments. This method of CTC identification is the
standard laboratory practice for cytopathological and histological
examination of tumour cells from tissue biopsy.
Results from this study showed that the Parsortix system was
able to harvest CTCs in a greater proportion of MBC patients (64%),
compared to the antibody-based system (57%), and 99% of the cancer
cells recovered by the Parsortix system had preserved morphology,
allowing morphological analysis, whereas less than 1% of the cells
recovered by the antibody-based system had preserved morphology. In
addition, samples processed using the Parsortix system were also
found to be of higher purity, with fewer blood cells present in the
harvest.
The proportion of MBC patients where cancer cells could be
harvested for analysis using the Parsortix system also
significantly exceeded the proportion of patients where cancer
cells can be recovered from metastatic sites using tissue biopsy as
less than 50% of MBC patients receive a successful tissue biopsy in
accordance with US National Comprehensive Cancer Network (NCCN)
clinical practice guidelines due to being too sick for the invasive
procedure, inaccessibility of the tumour or failed procedures.
The authors concluded that these results, combined with its ease
of use, position the Parsortix system as the optimal system for
integration into a routine cytopathology laboratory.
Breast cancer is the leading cause of cancer in women worldwide.
The National Cancer Institute estimates that 282,000 women will be
diagnosed with breast cancer in the US in 2021. A further 3.7
million US women are living with breast cancer. Despite a 5-year
relative survival rate of 90%, up to 30% of women will develop
metastatic disease. MBC patients where a tissue biopsy is not
feasible under NCCN guidelines, or is unsuccessful, are an
immediate focus for a liquid biopsy alternative to provide
information to guide treatment.
The research has been published as a peer-reviewed publication
in the journal Radiology and Oncology and may be accessed via
https://angleplc.com/library/publications/ .
Prof Veronika Kloboves-Prevodnik, Head of the Department of
Cytopathology, Institute of Oncology, Ljubljana, Slovenia
commented:
"This study, aimed to identify which of the two separation
methods is more appropriate for integration into our routine
clinical cytopathology laboratory. In our metastatic breast cancer
cohort, we found that the Parsortix system, was in general superior
to the antibody-based system in terms of purity, quality, and
quantity of CTCs. The advantage of the size-based Parsortix system
is its ability to harvest cells with a range of phenotypes. The
approach is promising and might be integrated into routine
cytopathology laboratory practice in the near future. To achieve
that, more data about immunocytochemical determination of CTC
phenotypes and correlation with clinical data are needed."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"We are pleased to see such promising results from a new
independent cancer centre which, again, demonstrates the strong
capabilities of the Parsortix system in isolating intact cancer
cells from a simple blood test at high purity for downstream
analysis using widely available methods. This is key to our aim of
establishing the Parsortix system as the global standard for liquid
biopsy from CTCs."
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 (US) +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 tumor 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 tumor. In addition, the live CTCs harvested
by the Parsortix system can be cultured, which offers the potential
for testing tumor 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
47 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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