TIDMAGL
RNS Number : 8764J
Angle PLC
05 April 2018
For immediate release 5 April 2018
ANGLE plc ("the Company")
FIRST PATIENT ENROLLED IN CLINICAL STUDY TO SUPPORT FDA
CLEARANCE OF THE PARSORTIX SYSTEM
FDA clearance would provide worldwide differentiation for the
Parsortix system in the multi-billion dollar liquid biopsy
market
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce that the first patient has been
enrolled into its ANG-002 FDA clinical study for metastatic breast
cancer. ANGLE is seeking to become the first ever company to
receive FDA Class II clearance for a product for harvesting intact
circulating tumor cells (CTCs) from patient blood for subsequent
analysis(1) .
The successful start of this study is the culmination of an
enormous amount of work to develop, test and finalise the protocols
involved and secure all of the necessary approvals for the clinical
study. There were significant technical issues that had to be
addressed in relation to the downstream analysis techniques.
Optimisation of the techniques used to analyse cells harvested by
the Parsortix(TM) system has required the development of know-how
which, now successfully completed, adds to the overall capability
and differentiation of the Parsortix system in the market.
FDA clearance is the de facto global gold standard for in vitro
diagnostic tests as well as a legal requirement for sale of the
product for the intended clinical use in the United States.
Securing FDA clearance has the potential to differentiate ANGLE in
the liquid biopsy market, validating the clinical and analytical
performance of the system and thereby positively influencing
Parsortix system adoption worldwide.
The clinical study involves recruitment of 200 metastatic breast
cancer patients and 200 healthy volunteers enrolled at leading US
cancer centres and is designed to support potential clearance by
the FDA for the following intended use:
"The Parsortix(TM) PC1 instrument is an in vitro diagnostic
device intended to harvest circulating tumor cells (CTCs) from the
peripheral blood of patients diagnosed with metastatic breast
cancer. Harvested CTCs can be used in subsequent analyses."
The primary endpoint of the clinical study, being led by MD
Anderson, is the cytological evaluation of harvested cells
confirming that CTCs are harvested from metastatic breast cancer
patients but not from healthy volunteers.
The exploratory endpoints are to demonstrate that, in addition
to the cytological evaluation, the Parsortix harvested cells can be
analysed using quantitative PCR (qPCR, MD Anderson), fluorescence
in situ hybridisation (FISH, University of Southern California) and
whole transcriptome sequencing (RNA-Seq, University of Southern
California). As announced on 6 February 2018, ANGLE has signed an
agreement with the global healthcare company Abbott to use its
proprietary PathVysion HER-2 DNA FISH Probe kits in the study.
Abbott is the global market leader for FISH testing in solid tissue
biopsies. A positive result in this clinical study would
demonstrate the potential for Abbott to offer a Parsortix-based
product for HER-2 analysis from a routine blood test.
The enrolment of the patients and healthy volunteers are under
the direct control of the independent cancer centres and outside
the control of the Company. Once the rate of enrolment and general
progress of the clinical study becomes clear we will update the
market on likely timescales. Current expectations continue to be
that both the clinical study and the associated analytical studies
will complete in H2 CY 2018.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We believe there is a tremendous opportunity for ANGLE to
secure the first ever FDA Class II clearance for harvesting 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.
The FDA clearance process is highly technically challenging. ANGLE
has successfully met the many challenges involved in establishing
the study and we are now into the next stage of executing the
clinical study. We look forward to reporting further progress in
due course."
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, Kate
Bannatyne
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 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 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 based on
harvesting 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/
This information is provided by RNS
The company news service from the London Stock Exchange
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