TIDMAGL
RNS Number : 5295E
Angle PLC
19 July 2016
For immediate release 19 July 2016
ANGLE plc ("the Company")
INITIATION OF TWO HUNDRED PATIENT EUROPEAN OVARIAN CANCER
STUDY
Four leading European cancer centres recruiting patients
Significant step towards obtaining CE-marked Parsortix-based
test that distinguishes between a benign and malignant pelvic
mass
ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech company,
is pleased to announce that its European ovarian cancer study has
been formally initiated and has recruited its first patient.
ANGLE has completed the complex and intensive process required
to initiate this study. This process included optimising the system
protocols for the application, developing and approving the study
plan and the data collection and study documentation tools,
obtaining ethics approval and contracting with leading cancer
centres, and designing and delivering all the necessary forms,
consumables and training required for the clinical study.
The four participating cancer centres, all of whom have been
through formal study initiation and training and are actively
recruiting patients, are:
-- Medical University of Vienna, key opinion leader for ovarian
cancer, leading the trial and responsible for analysing the patient
samples and optimising the RNA markers;
-- Charité - Universitätsmedizin Berlin, one of the largest
university hospitals in Europe;
-- Vivantes Network for Health GmbH with the Clinic for
Gynecology and Obstetrical Medicine in the Klinikum Auguste
Viktoria; and
-- Vivantes Network for Health GmbH with the Department of Gynecology, Hospital Neukölln.
Based in Berlin, Vivantes Network for Health GmbH is the largest
municipal hospital group in Germany, and the two clinics listed
above are within their two largest hospitals.
The ovarian cancer study (known as ANG-001) is a 200 patient
study, recruiting women diagnosed with a pelvic mass by imaging
studies who are scheduled to receive surgery for the removal of
their masses. Blood from consenting patients will be analysed using
the Parsortix(TM) system and RNA from the cell harvests will be
evaluated to detect the presence or absence of ovarian CTCs
(circulating tumour cells). The aim is to discriminate successfully
between women with benign and malignant masses as confirmed by the
histopathological examination of the tissue post-surgery.
The first half of patients enrolled into the ANG-001 study will
be used as a training set to determine which of the RNA markers
previously investigated are optimal for the detection of ovarian
cancer CTCs harvested by the Parsortix system. The remainder of the
patients enrolled into the study will be used as a verification set
to verify that these RNA markers are successful at discriminating
between women with benign and malignant pelvic masses for
pre-surgical triaging.
Whilst the speed of patient recruitment is outside of ANGLE's
control, the aim is to complete the study by 2016 calendar year
end.
Successful completion of the ANG-001 study would enable ANGLE to
offer the Parsortix system to accredited European hospitals where a
laboratory developed test (LDT) based on the RNA markers identified
to assess the malignancy status of women prior to surgery for
abnormal pelvic mass would be able to be designed. An LDT requires
the hospital concerned to validate the test under their own quality
control system. The centres conducting the trial are likely to be
early adopters, leading to the potential for early revenues.
Based on the results of the ANG-001 study, ANGLE expects to
design and conduct a further, appropriately powered, prospective
clinical study to validate the clinical utility of the offering of
Parsortix with the downstream RNA analysis. The successful
validation would allow ANGLE to fulfil the In Vitro Diagnostic
Directive (CE marking) requirements for the combined product so
that all hospitals in Europe would be able to offer the test
without having to validate it within their own quality control
system.
ANGLE is also working on plans to execute a similar study in the
United States.
Ovarian cancer surgery is highly complex and maximal tumour
removal has a very strong impact on survival. Women with the
diagnosis or a strong indication of ovarian cancer can be referred
for surgery to specialists in gynaecologic oncology. The
consequence is a significantly better outcome compared to the
situation when surgery is performed by a general gynaecologist and
cancer is diagnosed at this point. There would therefore be great
clinical benefit if it were possible to know in advance of surgery
if an abnormal pelvic mass is malignant. Conversely, women with
benign pelvic mass may be more easily and cost effectively treated
by a general surgeon in their local hospital. ANGLE estimates that
the addressable global market for the pre-surgical assessment of
ovarian cancer risk, available for Parsortix sales, could be in
excess of GBP300 million per annum.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"It has been a huge effort to put this clinical study in place
and we are now excited to see the study in progress. The four
participating centres are enthusiastic and committed and we look
forward to the next stage of development of this important clinical
application."
For further information:
ANGLE plc 01483 685830
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Cenkos Securities
Stephen Keys (Nominated adviser)
Russell Kerr, Oliver Baxendale
(Sales) 020 7397 8900
WG Partners
David Wilson
Claes Spång 020 3705 9330
FTI Consulting
Simon Conway, Mo Noonan,
Stephanie Cuthbert 020 3727 1000
Kimberley 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 specialist medtech 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 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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