TIDMAGL
RNS Number : 3222F
Angle PLC
27 July 2016
For immediate release 27 July 2016
ANGLE plc ("the Company")
INITIATION OF 200 PATIENT UNITED STATES OVARIAN CANCER STUDY
Leading United States cancer centre recruiting patients;
complements recently started European study also in ovarian
cancer
ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech company,
is pleased to announce that it has initiated an ovarian cancer
study in the United States, in addition to its recently opened
European ovarian cancer study. The US study is being led by Dr
Richard Moore at the University of Rochester Medical Center Wilmot
Cancer Institute (New York State).
Preparation and approvals for the US ovarian cancer study (known
as the ANG-003 EMBER study) have been ongoing over recent months.
The study has now been formally opened and the first few patients
have already been recruited.
The EMBER study is designed to enrol approximately 200 women
with a diagnosed pelvic mass who are scheduled to undergo biopsy,
laparotomy or laparoscopic surgery at the University of Rochester
Medical Center. Enrolment will continue until a total of 50
evaluable women with a histopathologically confirmed malignancy
have been identified. Blood from consenting patients will be
processed using the Parsortix(TM) system to harvest any circulating
tumour cells (CTCs) that may be present for evaluation. The
Parsortix harvests from the women enrolled into the study will be
evaluated for the presence of markers associated with malignancy in
ovarian cancer cells. These results will then be compared with the
histopathological diagnoses post-surgery to assess their
association with whether the pelvic mass is benign or
malignant.
Additionally, a portion of the Parsortix harvest from each
patient will be stored so that it can subsequently be used for
verification of the molecular markers identified in ANGLE's
European ovarian cancer study (ANG-001) as being optimal for the
detection of ovarian cancer CTCs harvested by the Parsortix
system.
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 known in advance of surgery that an
abnormal pelvic mass is malignant. Conversely, women with benign
pelvic mass may be treated more easily and cost effectively 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.
The University of Rochester Medical Center is an integrated
academic health center with experts and significant research
interests in the area of women's health. Dr Moore, the Director of
the Gynecologic Oncology Division, leads Wilmot Cancer Institute's
Gynecology Service Line and serves as Director of the Targeted
Therapeutics Laboratory for Gynecologic Cancers.
Dr Moore, an internationally recognised expert on the use of
biomarkers to detect ovarian cancer, is ideally qualified to assist
ANGLE in its efforts to develop a diagnostic assay for the
detection of ovarian cancer. He led the team that developed the
Risk of Ovarian Malignancy Algorithm (ROMA), one of two tests
currently cleared by the FDA for use as an aid in assessing whether
a premenopausal or postmenopausal woman who presents with an
ovarian adnexal mass is at high or low likelihood of finding
malignancy on surgery. ROMA is based on the HE4 and CA125
biomarkers, which may be over-expressed in the blood of ovarian
cancer patients.
Dr Richard Moore, Director of the Gynecologic Oncology Division,
University of Rochester Medical Center Wilmot Cancer Institute,
commented:
"There remains a large unmet medical need to accurately
discriminate benign from malignant pelvic masses before surgery. I
am delighted to be working with the Parsortix system. As it works
with live cancer cells rather than general markers of disease, it
offers the potential for high specificity avoiding the problem of
false positives that affects all existing techniques."
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"The initiation of this US study reflects ANGLE's determination
to secure substantial patient data from multiple locations as soon
as possible to demonstrate the effectiveness of the ovarian
clinical application and support regulatory approval. We are
delighted that Dr Moore and his team at University of Rochester
Medical Center are progressing this study so rapidly."
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
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 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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