Angle PLC ENROLMENT COMPLETE FOR FDA CLINICAL STUDY (1007S)
March 07 2019 - 2:01AM
UK Regulatory
TIDMAGL
RNS Number : 1007S
Angle PLC
07 March 2019
For immediate release 7 March 2019
ANGLE plc ("the Company")
ENROLMENT COMPLETE FOR FDA CLINICAL STUDY
Submission to the FDA expected mid-year as planned
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce that enrolment for its Parsortix
FDA clinical study for metastatic breast cancer is now
complete.
We are grateful to the four leading US cancer centres, the
University of Texas MD Anderson Cancer Center, the University of
Southern California Norris Cancer Center, the University of
Rochester Wilmot Cancer Center, and the Northwestern University
Robert H Lurie Cancer Center for their efforts in completing
enrolment of all of the required 400 evaluable subjects.
Downstream analyses of the samples will now be completed by the
centres and the evaluation of the results from the clinical study
and the ongoing analytical studies will be completed with the aim
of a submission to the FDA mid-year, as planned. The timing of FDA
regulatory clearance is dependent on the FDA's review and response
to our submission. As we are following a de-novo process for the
first potential FDA clearance(1) of a system intended for
harvesting cancer cells from patient blood for subsequent analysis,
it is not possible to predict with certainty how long this process
will take.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"Completion of the enrolment for our Parsortix FDA clinical
study is a key milestone for ANGLE. 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."
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 +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
This announcement contains inside information.
For Frequently Used Terms, please see the Company's website on
http://www.angleplc.com/the-parsortix-system/glossary/
Notes for editors
1. Despite the estimated addressable market potential for liquid
biopsy of greater than US$100 billion per annum across all cancer
types in the United States alone (Frost and Sullivan, November
2018), to date, the FDA has cleared only two liquid biopsy
applications. The first clearance, for CellSearch, was for CTC
enumeration (counting) to assess prognosis in metastatic breast,
colorectal or prostate cancers. This contrasts with ANGLE's
intended use to capture and harvest CTCs for subsequent analysis.
The second clearance, for a liquid biopsy application on the Roche
Cobas platform, was for utilising ctDNA (fragments of dead cancer
cells) to investigate the presence of an EGFR gene mutation in
non-small cell lung cancer. ANGLE is seeking to become the first
company ever to obtain FDA clearance for a liquid biopsy platform
that will capture and harvest CTCs for subsequent analysis, in the
first instance for metastatic breast cancer patients.
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 an epitope-independent 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(TM)
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 downstream subsequent analyses. CTCs enable
the complete picture of a cancer to be seen as they allow DNA, RNA
and protein analysis and the live cells harvested can be cultured.
The Parsortix technology is the subject of 21 granted patents in
Europe, the United States, Canada, India, China, Japan and
Australia with three extensive families of patents are being
progressed worldwide. The system is based on a microfluidic device
that captures cells based on a combination of their size and
compressibility. 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 study 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
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 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 QIAGEN, Abbott and
Philips, 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
18 peer-reviewed publications and numerous publicly available
posters, available on our website.
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END
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