TIDMAGL
Angle PLC
27 February 2020
For immediate release 27 February 2020
ANGLE plc ("the Company")
PARSORTIX OUTPERFORMS OTHER CTC SYSTEMS IN RENAL CELL
CARCINOMA
Publication in International Journal of Molecular Sciences
demonstrates benefits of Parsortix "unbiased" CTC enrichment
process
Workflow combines Parsortix with downstream process for single
cell analysis of each individual cancer cell
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that Istituto Nazionale Tumori di
Milano, Milano, Italy has published results of work, which assessed
the performance of Parsortix(R) in renal cell carcinoma (RCC)
demonstrating key advantages of the Parsortix system.
The disease is often asymptomatic (few or no symptoms) and about
30% of patients with RCC present with metastatic disease. Their
prognosis is poor with an overall 5-year survival rate of less than
20%. A number of targeted therapies have recently become available
and a liquid biopsy to determine whether such treatments might
benefit individual patients would be highly valuable.
Legacy circulating tumor cell (CTC) antibody-based systems have
been ineffective in RCC due to low expression of epithelial markers
on the CTCs. Istituto Nazionale Tumori di Milano compared the
performance of a Parsortix-based approach with a leading
alternative CTC system. The Parsortix system was combined with a
single cell picking system so that individual CTCs could for the
first time, in this tumor type, be harvested and then analysed to
assess the heterogeneity of the CTCs.
The Parsortix system greatly out-performed the alternative
approach and, being a marker-independent approach for CTC
enrichment, it was described in the publication as being
"instrumental for increasing CTC detection and for being able to
separately identify the sub-populations by immunostaining".
The pilot study suggested that even the presence of a single CTC
in a blood sample prior to treatment may predict a reduced
progression free survival.
The research has been published as a peer-reviewed publication
in the International Journal of Molecular Sciences and may be
accessed via https://angleplc.com/library/publications/ .
Dr Vera Cappelletti, Group Leader, Istituto Nazionale Tumori di
Milano, Milano, Italy, commented:
"There is a major unmet clinical need in renal cell carcinoma
for personalised treatment decisions. We hope that this original
work will pave the way for further investigation of how Parsortix
can be used to benefit patients with tumor types characterised by
low expression of epithelial markers, such as renal cell
cancer."
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"This publication adds to the body of evidence demonstrating the
strong advantages of the Parsortix system identifying new potential
uses of the system to improve the care of cancer patients."
As previously announced, f ollowing a Q-Submission meeting in
January with the US Food and Drug Administration (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
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 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 (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
29 peer-reviewed publications and numerous publicly available
posters, available on our website.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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