GUILDFORD, United Kingdom,
Jan. 27, 2015 /PRNewswire/ -- ANGLE
plc (AIM: AGL OTCQX: ANPCY), the specialist medtech company, is
delighted to announce that the Medical University of Vienna, one of its key opinion leaders, has
reported highly convincing patient data in support of the use of
ANGLE's Parsortix system in the detection of ovarian cancer.
The Medical University of Vienna will now lead, in collaboration with
ANGLE, a clinical study of the use of the Parsortix system as a
clinical application in the routine detection and treatment of
ovarian cancer patients. The multi-centre clinical study will
be in collaboration with other members of the European Network for
Translational Research in Ovarian Cancer (EUTROC) and the Tumour
bank Ovarian Cancer Network (TOC) from Austria, Belgium, Germany and UK. It is expected to take
18 months to complete. Assuming the clinical study confirms
the recent patient study results then ANGLE will be able to make
clinical sales of the Parsortix system to help inform detection of
ovarian cancer and clinical decision-making in its treatment.
The patient study was undertaken under ANGLE's collaboration
agreement with the Ludwig Boltzmann Cluster 'Translational
Oncology' led by the head of the interdisciplinary Molecular
Oncology Group at the Medical University of Vienna, Professor Robert Zeillinger. The study utilised RNA
markers developed in Vienna to
analyse the cells harvested by ANGLE's Parsortix system.
The Vienna team has worked for
many years with a wide range of CTC systems, both those
commercially available from ANGLE's competitors and new
technologies under development including commercial and academic
systems. Due to lack of suitable cell surface markers,
antibody-based systems are ineffective for ovarian cancer.
The best result that has been obtained to date with other
non-antibody based systems is a CTC detection sensitivity level of
24.5% (i.e. capturing CTCs from only one quarter of ovarian cancer
patients).
Against this context, Dr Eva
Obermayr, Principal Investigator at the Medical University
of Vienna describes the results
with ANGLE's Parsortix system as "sensational" and offering
"unprecedented sensitivity and specificity". The results
indicated a sensitivity of 90% for primary epithelial ovarian
cancer at a specificity of 100%. Epithelial ovarian cancer
(also known as ovarian carcinoma) is the most common ovarian cancer
and accounts for some 90% of cases.
If these results are repeated in a prospective clinical study,
Professor Zeillinger believes that ANGLE's Parsortix system
together with the proprietary RNA marker panel could be adopted in
clinical practice to help inform clinical decision-making for
ovarian cancer patients in:
- Detection of cancer in high risk or genetically pre-disposed
patients (detection)
- Monitoring therapy and selection of therapies in treatment of
ovarian cancer patients (therapy monitoring)
- Monitoring of ovarian cancer patients in remission for early
detection of relapse (remission monitoring)
ANGLE estimates that the ovarian cancer sales potential
available for the Parsortix system in the European and United States markets would be in excess of
£300 million per annum.
Annually 239,000 women are diagnosed with ovarian cancer
worldwide. There is a high mortality rate and 152,000 die
from it each year. Ovarian cancer is commonly known as the
silent killer due to its lack of symptoms in its earlier
stages. It is frequently diagnosed late in which case the UK
five year survival rate is only 3.5% for Stage IV and 18.6% for
Stage III at diagnosis (Source: Cancer Research UK Ovarian Cancer
survival statistics). In contrast where it is diagnosed at
Stage I, the UK five year survival rates are much higher at
90%. As a result there is an acute medical need for improved
ovarian cancer detection.
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.
A common approach is to use a blood test for the biomarker
CA-125 for detection of epithelial ovarian cancer, either alone or
in combination with another marker HE4. However the quoted
sensitivity for CA-125 is only 63% (i.e. 37% of cancers are missed
as false negatives) and as a result it is not considered
effective.
Vermillion, a US Nasdaq listed company, has developed OVA1, an
alternative epithelial ovarian cancer test that integrates
biomarker measurement in blood and a software algorithm, which is
FDA authorised and the company is now beginning to
commercialise. The Medicare reimbursement level for OVA1 is
$516. The company estimate
that, in the United States alone,
there are some 200,000 patients with abnormal pelvic masses where
surgery is undertaken, which may be investigated with OVA1 (of
which 22,000 will have ovarian cancer) suggesting a United States market for a specific segment of
the larger detection market of in excess of $100m per annum. There is a substantially
larger patient population in the United
States of some 750,000 per annum if all abnormal pelvic
masses are investigated. Vermillion quotes a sensitivity of
93% and specificity of 43% for OVA1 and indicates that this is a
considerable improvement over CA-125.
If the clinical study confirms the patient data announced today
then ANGLE's Parsortix system has the potential to substantially
out-perform the current standard of care in ovarian cancer,
particularly in relation to specificity (i.e. if a person does not
have the disease how often will the test be negative).
The group at the Medical University of Vienna believes that the exceptionally good
results with the Parsortix system are explained by the high purity
of the Parsortix harvest (very low numbers of leukocytes) combined
with the sensitivity of their RNA markers.
Professor Robert Zeillinger,
Head of the Molecular Oncology Group at the Medical University of
Vienna, commented:
"Using
ANGLE's Parsortix system with a panel of ovarian carcinoma-specific
RNA markers, we were able to detect and analyse CTCs in 90% of
patient samples at a specificity of 100%. This is an unprecedented
test performance and we will be immediately moving to a clinical
study to validate the use of this system in the detection and
treatment of ovarian cancer patients. We will also be
preparing a high impact publication on these results for discussion
with our colleagues in ovarian cancer worldwide."
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"These are
highly encouraging results for the use of the Parsortix
system. There is a very strong medical need in ovarian cancer
for earlier detection and monitoring of patients and we hope our
Parsortix system will be able to really make a difference.
Commercially ovarian cancer is a substantial but tightly defined
market where there is little competition. It is an ideal
first clinical market for ANGLE to progress. We will be
focusing our resources to deliver this opportunity as quickly as
possible. Today's announcement marks the start of ANGLE
moving into the clinical phase."
For further information please visit: www.angleplc.com.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/angle-plc-the-company-patient-data-shows-unprecedented-sensitivity-and-specificity-for-parsortix-ovarian-cancer-clinical-application-300026398.html
SOURCE ANGLE plc
