TIDMAGL
RNS Number : 1584N
Angle PLC
30 May 2022
For immediate release 30 May 2022
ANGLE plc ("the Company")
PARTNERSHIP ESTABLISHED WITH A MAJOR UNITED STATES UROLOGY GROUP
TO CONDUCT CLINICAL STUDIES IN PROSTATE CANCER AND AS A POTENTIAL
ROUTE TO MARKET
MidLantic Urology to evaluate the Parsortix system in prostate
cancer clinical studies and enable potential sales to Solaris
Health extensive patient base
Major unmet medical need for a pre-screening tool ahead of
invasive prostate tissue biopsy as an aid to assessing prostate
cancer presence and aggressiveness to guide treatment choices
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce it has signed a master clinical
study agreement with Solaris Health Holdings, LLC (Solaris) and
joinder agreements with MidLantic Urology LLC, to collaborate and
conduct clinical studies in prostate cancer and as a potential
route to market in the United States.
MidLantic Urology, an affiliate of Solaris, is one of the
largest providers of specialist urology services in the United
States with more than 70 physicians operating from 47 dedicated
urology centres across the state of Pennsylvania. The Solaris
Health network encompasses more than 500 clinical urology providers
across 179 locations and nine States with more than 729,000 unique
patients annually.
Together with MidLantic Urology, ANGLE will initiate clinical
studies aimed at investigating the use of the Parsortix(R) system
for the detection of prostate cancer and prediction of its severity
in patients who present with an elevated prostate specific antigen
(PSA) level and/or abnormal digital rectal exam.
The design of the first study to be conducted with MidLantic
Urology, expected to be initiated in Q3 2022, has been informed by
earlier pilot studies independently conducted at the Barts Cancer
Institute (Queen Mary University London) which used the Parsortix
system to harvest circulating tumour cells (CTCs). This study will
initially enrol 100 men scheduled to undergo a prostate tissue
biopsy at a minimum of three study sites over an anticipated period
of up to nine months. Blood samples collected by MidLantic Urology
will be shipped to ANGLE's United States clinical laboratory for
processing by the Parsortix system to harvest and analyse CTCs and
associated immune cells. The Parsortix harvests will be evaluated
by both imaging and molecular analysis to assess the potential to
predict the presence of clinically significant prostate cancer
prior to tissue biopsy and to assess potential correlation with
established disease severity scores (e.g. the Gleason score) in
those patients found to have prostate cancer.
ANGLE expects headline results from the first study of 100 men
in 2023. Compelling data could form the basis of a laboratory
developed test which ANGLE would offer from its clinical
laboratories in the United States and the UK. Solaris could be
ANGLE's first route to market for this test, offering the
established test to their extensive patient base. Successful
results could also allow the design of a larger validation study to
support an eventual submission to FDA and other regulatory bodies
for this application.
Prostate cancer is the leading cause of cancer in men and
accounts for 13% of all new cancer cases in the United States.
Under the national screening programme, 11 million men will undergo
a PSA test in the US each year. Of these, some 1.2 million will
have an abnormal result, leading to further investigations. The
current standard of care, transrectal or transperitoneal prostate
tissue biopsy, is an invasive procedure associated with significant
clinical complications and cost. Following the procedure, 32% of
patients are reported to experience moderate side effects, with
1.4% of patients experiencing major complications. This includes
post-biopsy sepsis in 2-5% of cases with up to 25% requiring
admission to ICU at an estimated cost of US$19,000 per patient.
Prostate tissue biopsies are negative in 75% of patients and
therefore place patients at unnecessary risk but may also miss the
cancer in 30-40% of cases, requiring patients to undergo repeat
tissue biopsy. 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 post-procedure complications including
urinary incontinence and erectile dysfunction. Liquid biopsy offers
the potential for a much safer, cost-effective diagnosis, active
surveillance where appropriate and, following diagnosis, the
ability to offer longitudinal monitoring and up to date targeted
treatment selection.
Dr Jose Moreno, Principal Investigator, MidLantic Urology,
commented:
" Even though PSA is a valuable marker of response to prostate
cancer treatment, its role in screening is modest at best and can
lead to both overdiagnosis of clinically indolent prostate cancer
and underdiagnosis of clinically significant prostate cancer which
can result in increased rates of local failure and metastatic
disease.
ANGLE's Parsortix platform has the potential to enable molecular
characterisation of the cancer using a blood test in patients
undergoing both traditional ultrasound biopsies and MRI fusion
biopsies. The preliminary data suggest that we may be able to
create an assay for the detection of clinically significant
prostate cancer that has high specificity and sensitivity.
Moreover, the assay can be customized to operate in a wide spectrum
of prostate cancer disease states, including pre-prostate biopsy,
after a negative biopsy, active surveillance, after local failure,
and in early and late metastatic disease states. If our results are
validated, our MidLantic Urology patients and Solaris Health
affiliates may be the first to benefit from these
developments."
ANGLE Founder and Chief Executive, Andrew Newland, added:
"We are delighted that Solaris and MidLantic Urology have agreed
to work with ANGLE on clinical studies in prostate cancer, which
build on prior work done by Barts Cancer Institute and demonstrates
the power of our leveraged research approach. Successful
development of this simple blood test could prevent men from being
subjected to unnecessary tissue biopsies when they either do not
have prostate cancer (despite the elevated level of PSA) or their
cancer is indolent and unlikely to impact either their life
expectancy or quality of life.
The funding for this study, which addresses a major unmet
medical need, was a key element of our capital raise last year and
could open up a significant market opportunity for ANGLE.
Initiation of the study, expected in the near future, delivers on
another business milestone as we build out our commercial plans for
the Parsortix system."
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)
Max Jones, Thomas Bective +44 (0) 20 7029 8000
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the EU Market Abuse Regulation (596/2014) . Upon the publication of
this announcement via a regulatory information service, this
information is considered to be in the public domain.
For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/glossary/
Notes for editors
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 a circulating tumor cell (CTC) harvesting
technology known as the Parsortix(R) system and a downstream
analysis system for cost effective, highly multiplexed analysis of
nucleic acids and proteins.
ANGLE's Parsortix(R) system is FDA cleared for its intended use
in metastatic breast cancer and is currently the first and only FDA
cleared medical device to harvest intact circulating cancer cells
from blood.
Intended use
The Parsortix(R) PC1 system is an in vitro diagnostic device
intended to enrich circulating tumor cells (CTCs) from peripheral
blood collected in K(2) EDTA tubes from patients diagnosed with
metastatic breast cancer. The system employs a microfluidic chamber
(a Parsortix cell separation cassette) to capture cells of a
certain size and deformability from the population of cells present
in blood. The cells retained in the cassette are harvested by the
Parsortix PC1 system for use in subsequent downstream assays. The
end user is responsible for the validation of any downstream assay.
The standalone device, as indicated, does not identify, enumerate
or characterize CTCs and cannot be used to make any
diagnostic/prognostic claims for CTCs, including monitoring
indications or as an aid in any disease management and/or treatment
decisions.
The Parsortix system enables a liquid biopsy (a simple blood
test) to be used to provide the circulating metastatic breast
cancer cells 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 phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as
well as CTC clusters in a viable form (alive). CTCs harvested from
the system enable a complete picture of a cancer to be seen; as
being an intact cell they allow DNA, RNA and protein analysis as
well as cytological and morphological examination and may provide
comparable analysis to a tissue biopsy in metastatic breast cancer.
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.
In the United States, the Parsortix(R) PC1 system has received a
Class II Classification from FDA for use with metastatic breast
cancer patients. FDA clearance is seen as the global gold standard.
ANGLE's Parsortix system is the first ever FDA cleared system for
harvesting CTCs for subsequent analysis. ANGLE has applied the IVD
CE Mark to the same system for the same intended use in Europe.
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
60 peer-reviewed publications and numerous publicly available
posters from 31 independent cancer centres, available on our
website.
ANGLE has established clinical services laboratories in the UK
and the United States to accelerate commercialisation of the
Parsortix system and act as demonstrators to support product
development. The laboratories offer services globally 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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