TIDMAGL
Angle PLC
20 October 2020
For immediate release 20 October 2020
ANGLE plc ("the Company")
ANGLE'S FDA SUBMISSION ACCEPTED BY FDA FOR SUBSTANTIVE
REVIEW
Full Class II De Novo FDA Submission seeking clearance of the
Parsortix system for metastatic breast cancer has successfully
completed FDA administrative review
ANGLE believes that the earliest prospect of FDA clearance is Q2
CY21*
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that FDA has completed its
administrative review and accepted ANGLE's FDA submission for
substantive review.
As announced on 28 September 2020, ANGLE has submitted a full
Class II De Novo FDA Submission for its Parsortix(R) PC1 system
seeking FDA clearance for use with metastatic breast cancer (MBC)
patients ("the Submission"). ANGLE has now received an Acceptance
Review Notification from FDA that the Submission has been accepted.
The administrative acceptance review is a formal process undertaken
by FDA to determine that the Submission contains all of the
necessary elements and information needed by FDA to proceed with
substantive review.
The Submission is the output of five years' work including
extensive dialogue with FDA, and the development of over 400
technical reports and documents, which have been submitted to
FDA.
FDA's goal is to make a decision about a De Novo request in 150
review days. Review days are calculated as the number of calendar
days between the date the De Novo request was received by FDA and
the date of FDA's decision. The review clock stops, however, when
FDA requests further information or clarification from the Company.
ANGLE believes that the earliest prospect of FDA clearance is Q2
CY21.*
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We are pleased that our FDA submission has successfully
completed FDA administrative review and is now in substantive
review. We believe there is a tremendous opportunity for ANGLE to
secure the first ever FDA clearance for a platform that captures
and harvests intact circulating tumour cells from patient blood for
subsequent analysis, in the first instance for metastatic breast
cancer."
* ANGLE is following a De Novo FDA process for Parsortix, as
there is no predicate device. Consequently, there is inherent
uncertainty over the timing of the process and its ultimate
success.
For further information:
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
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, Stephanie
Cuthbert +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
thus 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. In addition, the live
CTCs harvested can be cultured, which offers the potential for
testing 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 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 programme 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
36 peer-reviewed publications and numerous publicly available
posters, available on our website.
This information is provided by Reach, the non-regulatory press
release distribution service of RNS, part of the London Stock
Exchange. 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.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
NRAGPGUPUUPUPGB
(END) Dow Jones Newswires
October 20, 2020 02:00 ET (06:00 GMT)
Angle (LSE:AGL)
Historical Stock Chart
From Apr 2024 to May 2024
Angle (LSE:AGL)
Historical Stock Chart
From May 2023 to May 2024