TIDMAGL
RNS Number : 1161Q
Angle PLC
04 June 2018
For immediate release 4 June 2018
ANGLE plc ("the Company")
ENCOURAGING PROGRESS IN ANG-002 FDA CLINICAL STUDY
Four leading US cancer centres now initiated with enrolment of
over 80 subjects completed
Continue to expect the clinical and analytical studies to
complete in H2 CY 2018
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 is making
encouraging progress. ANGLE is seeking to become the first ever
company to receive FDA clearance for a platform that captures and
harvests intact circulating tumor cells (CTCs) from patient blood
for subsequent analysis, being one of only three FDA cleared liquid
biopsy solutions(1) .
Over 80 subjects have so far been enrolled out of a required 400
subjects for the study (200 metastatic breast cancer patients and
200 healthy volunteers of a similar age and demographic). This has
been achieved with two centres being open to enrolment since April.
Two additional centres were opened to enrolment at the end of May,
so there are now four leading US cancer centres actively recruiting
patients for the ANG-002 clinical study and enrolment is expected
to begin accelerating.
The study is blinded and results will not be known until the
trial is completed. The primary endpoint of the study is the
cytological evaluation of harvested cells by a qualified
pathologist to confirm that CTCs are harvested from metastatic
breast cancer patients but not from healthy volunteers. Exploratory
endpoints include analysis of harvested cells with quantitative
RT-PCR, analysis with fluorescence in situ hybridisation (FISH) and
analysis with whole transcriptome sequencing (RNA-Seq), being three
of the primary types of downstream analysis beyond cytological
analysis.
While enrolment of subjects into this study is under the control
of the independent cancer centres and outside the Company's direct
control, the progress reported today suggests that both the
clinical study and the associated analytical studies will complete,
as planned, in H2 CY 2018.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We are pleased to announce today that patient enrolment to date
for our FDA study has been encouraging and we now have four leading
US cancer centres actively recruiting subjects for the study. We
continue to believe there is a tremendous opportunity for ANGLE to
secure the first ever FDA clearance for a platform that captures
and harvests intact circulating tumor 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 - Adrian Hargrave,
Simon Hicks, Max Bullen-Smith
Corporate Broking - Alice Lane, Nikita
Jain +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
Evan Smith, Anne Troy (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 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 Roche Cobas, was utilising ctDNA
(fragments of dead cancer cells) to investigate the presence of a
single gene, EGFR, as a companion diagnostic for one particular
drug, Tarceva, 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.
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 for
Europe 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 highly multiplexed, rapid
and sensitive capture of targets from a wide variety of sample
types. A proprietary chemistry allows for the capture and
amplification of over 100 biomarkers simultaneously in a single
reaction. These technologies can be combined to provide fully
automated, sample to answer results in both centralised laboratory
and point of use cartridge formats. It is ideal for measuring gene
expression and other markers directly from Parsortix harvests.
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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