RCS - Angle PLC - Prostate Cancer UK funds new study using Parsortix

AngleAnnouncement

20/05/2022 07:00

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RNS Number : 1779M  Angle PLC  20 May 2022

 For immediate release  20 May 2022

 

ANGLE plc ("the Company")

 

Prostate Cancer UK FUNDs new study using Parsortix

 

Research into the use of Parsortix-based CTC blood test to assess whether
prostate cancer patients require prostatectomy surgery

 

Potential for a new standard of care in an area of high unmet medical need

 

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is
pleased to announce that Prostate Cancer UK has approved funding for a
significant clinical study at Barts Cancer Institute, Queen Mary University of
London. The study will investigate the use of the Parsortix(®) system to
isolate circulating tumour cells (CTCs) as a predictor of future disease
recurrence. Assessment of whether prostate cancer is likely to progress, if
this can be done reliably, may have a major bearing on whether radical
prostatectomy surgery is the most appropriate treatment choice.

 

The trial is being funded by a £750,000 grant from Prostate Cancer UK and
will follow 200 men with localised prostate cancer over five years. The aim of
the study is to see whether the presence of mesenchymal CTCs and CTC clusters
in peripheral blood, assessed using the Parsortix system, can predict whether
the cancer will eventually spread. The study has been designed and will be
conducted by Barts Cancer Institute and is being funded by Prostate Cancer UK,
both independently from ANGLE. ANGLE has agreed to provide support for the
study through the provision of Parsortix instruments, cassettes and reagents.

 

The study will enrol patients who are due to have radical prostatectomy
surgery and will track them during and after treatment. The researchers will
take a blood sample before and at regular intervals after the surgery and
process the samples using the Parsortix system seeking to identify those
patients where disease progression subsequently occurs. The design of this
study has been informed by earlier pilot studies independently conducted at
Barts Cancer Institute using the Parsortix system.

 

The trial is blinded, so the doctors treating the patients will not know the
outcome of the blood tests. If the Parsortix system can be used to provide a
predictive assessment of disease progression despite radical prostatectomy, it
could have a significant impact on how prostate cancer is treated, making it
easier for doctors to choose the correct and most effective treatment option.

 

Prostate cancer is the leading cause of cancer in men with 1 in 8 men
diagnosed in their lifetime. In the UK more than 47,500 men are diagnosed with
prostate cancer each year and a further 400,000 are living with and after
prostate cancer. At least 60% of prostate cancers diagnosed are indolent and
unlikely to cause harm during a patient's lifetime. Nonetheless many men will
undergo radical prostatectomy which is associated with significant harms
including urinary incontinence and erectile dysfunction. There is equal risk
associated with undertreatment of aggressive disease and more than 11,500 men,
or one man every 45 minutes dies from prostate cancer in the UK each year.
Liquid biopsy offers the potential for a much safer, cost-effective diagnosis,
active surveillance and, following diagnosis, the ability to offer
longitudinal monitoring and up to date targeted treatment selection.

 

Yong-Jie Lu, lead researcher of the study and Professor of Molecular Oncology
at Barts Cancer Institute, Queen Mary University of London, commented:

"If our hypothesis is correct, we hope that this blood test will become the
future standard of care for these patients. Patients with localised prostate
cancer will be treated more efficiently and in a more personalised way, rather
than surgically removing the prostate and just waiting to see what happens.
Doctors will have more information about whether the cancer has really spread
or not, based on this test meaning patients won't be over or under-treated."

 

Dr Hayley Luxton, Research Impact Manager at Prostate Cancer UK, commented:

"We are delighted to support this trial which has the potential to inform
treatment decisions and improve outcomes for men living with prostate cancer.
Prostate cancer is the most common cancer in men, killing 11,500 people each
year in the UK. Being able to identify aggressive cancer beforehand will help
to ensure that men are receiving the right treatment at the right time."

 

ANGLE Founder and Chief Executive, Andrew Newland, added:

"We are pleased that Barts Cancer Institute is progressing investigation of
clinical application of the Parsortix system in prostate cancer and,
independent form the Company, has secured substantial funding from Prostate
Cancer UK. Our aim is that the Parsortix system will be widely adopted by
third parties seeking from their own initiative and funding to develop many
and varied uses of the Parsortix system to support cancer patients."

 

For further information:

 

 ANGLE plc                                   +44 (0) 1483 343434
 Andrew Newland, Chief Executive

 Ian Griffiths, Finance Director

 Andrew Holder, Head of Investor Relations

 Berenberg (NOMAD and Joint Broker)

 Toby Flaux, Ciaran Walsh, Milo Bonser       +44 (0) 20 3207 7800

 Jefferies (Joint Broker)                    +44 (0) 20 7029 8000

 Max Jones, Thomas Bective

 FTI Consulting

 Simon Conway, Ciara Martin                  +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/
(https://angleplc.com/investor-relations/glossary/)

 

Notes for editors

 

About ANGLE plc www.angleplc.com (http://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(®) 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 may
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 of a
patient's tumor. In addition, the live CTCs harvested by the Parsortix system
can be cultured, which offers the potential for testing tumor 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 are 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(®)
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
program 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 a 200
patient clinical verification study has now completed enrolment.

 

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids
of all types is called the HyCEAD(TM) 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 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 59
peer-reviewed publications and numerous publicly available posters, available
on our website.

 

ANGLE has established clinical services laboratories in the UK and USA to
accelerate commercialisation of the Parsortix system and act as demonstrators
to support product development. The laboratories offer services to
pharmaceutical and biotech customers for use of Parsortix in cancer drug
trials and, once the laboratories are accredited and tests validated, will
provide Laboratory Developed Tests (LDTs) for patient management.

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