TIDMAGL
RNS Number : 0003K
Angle PLC
04 July 2017
For immediate release 4 July 2017
ANGLE plc ("the Company")
ANGLE REPORTS SUCCESSFUL HEADLINE DATA IN US AND EUROPEAN
OVARIAN CANCER STUDIES IN 400 PATIENTS
Parsortix blood test demonstrates potential to out-perform
current standard of care in identifying ovarian cancer
ANGLE moves into validation phase of development for its first
clinical application
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce positive headline results from
400 patient pelvic mass studies, in the US and Europe,
demonstrating the potential for a Parsortix based blood test to
out-perform current tests in discriminating between benign and
malignant pelvic masses.
Evaluation of data from both ANGLE's European study (ANG-001)
led by Dr Robert Zeillinger at the Medical University of Vienna and
ANGLE's US study (ANG-003) led by Dr Richard Moore at the
University of Rochester Medical Center, Wilmot Cancer Institute
(New York State) shows that a test using the Parsortix system can
differentiate between women with a malignant pelvic mass and those
with benign tumours with a high degree of sensitivity (correctly
identifying cancer) of up to 95% whilst at the same time achieving
a higher specificity (low false positive rate) than existing
tests.
The Parsortix test combines both high sensitivity and high
specificity. Compared to CA125 for the ANG-003 samples, at a high
sensitivity the Parsortix result had nearly double the specificity
of the CA125 result.
These study results infer that best performance can be achieved
when combining selected gene information analysed from the
Parsortix harvest in an algorithm with certain patient condition
information. The algorithm, which is proprietary, will be further
optimised to give the best performance in the upcoming validation
study. It is expected that it will be possible to apply for patent
protection on the details of the algorithm strengthening ANGLE's
competitive positive further. Therefore, full details of the
analyses are being restricted until this process is complete. The
cancer centres involved will then publish the full results of the
studies in leading peer-reviewed publications.
ANGLE's Parsortix blood test has the potential to assist in the
diagnosis of ovarian cancer prior to a patient undergoing a biopsy
or surgery. This will enable women with ovarian cancer to be
referred to gynaecologic oncology surgeons and institutions that
specialise in the care of women with ovarian cancer, giving them
the best possible outcome for the treatment of their disease. At
the same time, it will allow patients with a benign tumour to be
cared for in their communities. This has the potential to reduce
healthcare costs and avoid the unnecessary transfer of patients
from their local hospital to specialist referral centres. The test
also has the potential to identify targets on the tumour that may
be used to inform treatment strategies.
The test is RNA-based and cannot be undertaken with ctDNA
techniques.
Professor Robert Zeillinger, Head of the Molecular Oncology
Group at the Department of Obstetrics and Gynaecology, Medical
University of Vienna, commented:
"The 200 patient ANG-001 clinical multi-centre study has shown
that the Parsortix based test allows us to successfully
discriminate patients with ovarian cancer from patients with a
non-malignant pelvic mass with a high degree of accuracy. Using
ANGLE's Parsortix system and a panel of RNA markers, there is the
prospect that we can meet a key medical need in triaging women
before surgery to ensure patients with cancer get the care they
need."
Dr Richard Moore, Director of the Gynecologic Oncology Division,
University of Rochester Medical Center Wilmot Cancer Institute,
commented:
"The 200 patient ANG-003 clinical study shows that the Parsortix
test has the ability to accurately discriminate malignant from
benign pelvic masses prior to biopsy or surgery. The test also
offers key additional benefits over existing practice through the
gene expression information it provides, which may help to further
guide choices for targeted therapy in women with ovarian cancer.
Additionally, the test may allow separate identification of
patients with low malignant potential and/or other cancer types
using a non-invasive liquid biopsy test."
Both Professor Zeillinger and Dr. Moore stated that: "The pilot
trials offer exciting new data supporting the Parsortix technology
and its continued development moving towards validation
trials."
The successful results announced today enable ANGLE to move into
the next phase of development of a commercial blood test addressing
an estimated market size of GBP300 million per annum. Firstly, the
test will be optimised to maximise performance. Some key aspects of
the downstream analysis techniques have been identified that ANGLE
believes can be enhanced to improve the performance of the assay
and provide an even stronger competitive advantage. The performance
of the optimised test will be confirmed utilising a second blood
sample that has been banked from each of the ANG-003 study
patients.
The performance of the optimised test will then be validated in
a separate set of patients through the conduct of appropriately
powered validation studies designed to meet European CE Mark and US
FDA regulatory requirements. Successful completion of these
validation studies will allow the commercial sale of the Parsortix
based pelvic mass test in the United States and Europe, and
eventually worldwide.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"ANGLE's first large scale clinical studies of 400 patients have
demonstrated positive results with the potential to out-perform
current standard of care. This success enables ANGLE to move
forward into the validation phase for the use of Parsortix in its
first clinical application. We believe ANGLE is building momentum
towards securing a leading and well differentiated commercial
position in the emerging multi-billion dollar liquid biopsy
market."
For further information:
ANGLE plc 01483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Cenkos Securities
Stephen Keys (Nominated adviser),
Steve Cox
Russell Kerr (Sales) 020 7397 8900
WG Partners
David Wilson
Claes Spång 020 3705 9330
FTI Consulting
Simon Conway, Mo Noonan,
Stephanie Cuthbert 020 3727 1000
Kimberly Ha (US) 001 212 850 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
About ANGLE plc www.angleplc.com
ANGLE is a world-leading liquid biopsy company commercialising a
disruptive platform technology that can capture cells circulating
in blood, such as cancer cells, even when they are as rare in
number as one cell in one billion blood cells, and harvest the
cells for analysis.
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, 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. Parsortix has a CE Mark for Europe and FDA
authorisation is in process for the United States.
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/
The analysis of the cells that can be harvested from patient
blood with ANGLE's Parsortix system has the potential to help
deliver personalised cancer care offering profound improvements in
clinical and health economic outcomes in the treatment and
diagnosis of various forms of cancer.
The global increase in cancer to a 1 in 3 lifetime incidence is
set to drive a multi-billion dollar clinical market. The Parsortix
system is designed to be compatible with existing major medtech
analytical platforms and to act as a companion diagnostic for major
pharma in helping to identify patients that will benefit from a
particular drug and then monitoring the drug's effectiveness.
As well as cancer, the Parsortix technology has the potential
for deployment with several other important cell types in the
future.
ANGLE stock trades on the AIM market of the London Stock
Exchange under the ticker symbol AGL and in New York on the OTC-QX
under the ticker symbol ANPCY. For further information please
visit: www.angleplc.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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