Angle PLC Good Progress with FDA Studies (1112F)
October 25 2018 - 1:00AM
UK Regulatory
TIDMAGL
RNS Number : 1112F
Angle PLC
25 October 2018
For immediate release 25 October 2018
ANGLE plc ("the Company")
GOOD PROGRESS WITH FDA CLINICAL AND ANALYTICAL STUDIES
Enrolment of over 75% of the subjects for the clinical study
complete
FDA clearance would provide further worldwide differentiation
for the Parsortix system in the emerging multi-billion dollar
liquid biopsy market
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is pleased to announce that patient enrolment for its
ANG-002 FDA clinical study for metastatic breast cancer continues
to make good progress. ANGLE is seeking to become the first ever
company to receive FDA clearance for a platform that captures and
harvests intact circulating tumour cells (CTCs) from patient blood
for subsequent analysis, being one of only three FDA cleared liquid
biopsy solutions(1) .
Over 75% of the required 400 subjects (200 metastatic breast
cancer patients and 200 healthy volunteers of a similar age and
demographic) have been enrolled into the study to date.
Whilst the enrolment of patients and analysis of results are
conducted by independent cancer centres and outside the control of
the Company, recent progress now suggests that both the clinical
study and associated analytical studies will be completed by the
end of Q1 CY 2019.
Meanwhile, extensive analytical studies continue at ANGLE's own
laboratories and at the participating clinical centres. As a result
of this work, new insights into the Parsortix(TM) system's rare
cell capture and harvest capabilities have emerged that will
further differentiate the Parsortix system in the market.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"Our significant and sustained efforts to complete the clinical
and analytical studies needed to support our FDA submission are
progressing well. 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. This would be a key step in
establishing the Parsortix system as the system of choice for CTC
liquid biopsy, securing a leading position in the emerging
multi-billion dollar liquid biopsy market."
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, Mo Noonan, Stephanie Cuthbert +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 212 850 5612
For Frequently Used Terms, please see the Company's website on
http://www.angleplc.com/the-parsortix-system/glossary/
This announcement contains inside information.
Notes for editors
1. Despite the market for liquid biopsy being forecast to be
worth over US$ 14 billion per annum in the United States alone by
2025 (Goldman Sachs), 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 (simple blood test) to be
used to provide the cells of interest. Parsortix is the subject of
granted patents in Europe, the United States, Canada, India, China,
Japan and Australia and three extensive families of patents are
being progressed worldwide. The system is based on a microfluidic
device that captures live 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.
ANGLE's analysis technology for proteins and nucleic acids of
all types is called Ziplex(R) 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 allows
for the capture and amplification of over 100 biomarkers
simultaneously in a single reaction. The Ziplex system is ideal for
measuring gene expression and other markers directly from Parsortix
harvests.
ANGLE's proprietary technologies can be combined to provide
automated, sample to answer results in both centralised laboratory
and point of use cartridge formats.
Furthermore, ANGLE has established formal collaborations with
world-class cancer centres. These Key Opinion Leaders are working
to identify applications with medical utility (clear benefit to
patients), and to secure clinical data that demonstrates that
utility in patient studies. Details are available here
http://www.angleplc.com/the-company/collaborators/
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END
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