TIDMAGL
RNS Number : 1262D
Angle PLC
17 February 2020
For immediate release 17 February 2020
ANGLE plc ("the Company")
LEADING KOL PUBLISHES ANALYTICAL AND CLINICAL DATA DEMONSTRATING
KEY ADVANTAGES OF PARSORTIX SYSTEM
Hamburg-Eppendorf developed validated standardised Parsortix
protocols for use in future clinical trials
Parsortix harvested cells allow for "robust amplification of
single cell DNA at excellent quality for subsequent molecular
analysis"
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that University Medical Centre
Hamburg-Eppendorf has published results of work undertaken to
assess the analytical and clinical performance of Parsortix in
multiple metastatic cancer types with the main emphasis on
metastatic breast cancer.
The work was completed as part of the pan-European CANCER-ID
consortium funded by the European Innovative Medicine Initiative
(IMI), which aims to standardise protocols and validate innovative
circulating tumour cell (CTC) detection approaches for future
clinical trials.
The results demonstrated the capability of the Parsortix system
to work with multiple different cancer types, using multiple blood
preservative tube types, and importantly capturing the full range
of CTCs, not just epithelial CTCs.
The researchers demonstrated that the CTCs harvested by the
Parsortix system were suitable for "robust amplification of single
cell DNA at excellent quality for subsequent molecular analysis".
Even in metastatic NSCLC (non small cell lung cancer) and
gastrointestinal cancer, which are known to be problematic for CTC
enrichment, the Parsortix workflow harvested CTCs in 46% of
patients notwithstanding treatment and disease condition. The
researchers stated in the publication that they had established
optimised enrichment protocols, utilising Parsortix, which ensured
robust performance.
The research has been published as a peer-reviewed publication
in the journal Cancers and may be accessed via
https://angleplc.com/library/publications/ .
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"This publication adds to the body of evidence supporting the
use of Parsortix in standard practice as part of personalised
cancer care. Hamburg-Eppendorf is considered a leader in Europe in
the field and their positive evaluation of Parsortix is an
important element in supporting the potential use of Parsortix in
future pharma services clinical trials."
As previously announced, f ollowing the Q-Submission meeting in
January with FDA, ANGLE is now progressing a full De Novo FDA
Submission with the prospect of FDA clearance in Q3 CY20, albeit
the outcome and timing of the FDA regulatory decision is entirely
dependent on the FDA's review and response to the Company's
submission.
For further information ANGLE:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon
Hicks, Max Bullen-Smith
ECM - Alice Lane, Sunila de Silva +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks, Andrew Craig,
Chris Lee +44 (0) 203 705 9330
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
The information communicated in this announcement is inside
information for the purposes of Article 7 of Regulation
596/2015.
For Frequently Used Terms, please see the Company's website on
http://www.angleplc.com/the-parsortix-system/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 a complete cell they allow
DNA, RNA and protein analysis and the live cells harvested can be
cultured. The Parsortix technology is the subject of 24 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 FDA clearance is in process for
the United States with a 400 subject clinical study and associated
analytical studies in metastatic breast cancer. ANGLE is seeking to
be the first ever FDA cleared CTC harvesting system and only the
third ever FDA cleared liquid biopsy test. ANGLE has already
undertaken 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 (ROC-AUC) 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 HyCEADTM 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 (ROC-AUC)
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
28 peer-reviewed publications and numerous publicly available
posters, available on our website.
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contact rns@lseg.com or visit www.rns.com.
END
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