GUILDFORD, England,
March 21, 2016 /PRNewswire/
-- ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech
company, is delighted to announce that the results of Barts Cancer
Institute's ongoing work with ANGLE's Parsortix system have
provided evidence in support of the use of Parsortix in the
detection and assessment of prostate cancer.
Barts patient data suggests that the Parsortix system may be
used both to detect prostate cancer and to assess its
aggressiveness, all through a simple blood test. This is
crucial because it means that men with low level disease could
avoid unnecessary and potentially harmful solid biopsy and surgical
intervention instead having "active surveillance", whereas men with
an aggressive form of disease could be fast-tracked for further
investigation and treatment. The current gold standard for
detection is the prostate-specific antigen (PSA) blood test, which
is known to have low sensitivity and low specificity (i.e. high
levels of false positives) and the digital rectal exam (DRE - which
is less effective than the PSA test). Where the PSA level is
high or the DRE indicates an enlarged prostate, a solid prostate
biopsy will be undertaken to detect cancer and assess the
aggressiveness of the disease. This process results in many
men having invasive biopsies unnecessarily.
Prostate cancer is the second most common cancer in men and the
fourth most common overall. More than 1.1 million new cases of
prostate cancer were recorded in 2012, accounting for around 8 per
cent of all new cancer cases and 15 per cent in men with an
estimated 3.9 million men living with the disease (Source: World
Cancer Research Fund International) and as the risk increases with
age and men are living longer these numbers are increasing.
There is a far larger population of men with a variety of symptoms
that require investigation for the possibility of prostate cancer
but do not have the disease. Currently these men are
frequently subjected to solid prostate biopsy, which, even if it is
negative for cancer (which is the case in 75% or more of solid
biopsies), is painful, may miss the cancer and can cause
infection. A simple blood test to assess whether this
procedure is necessary would improve patient care as well as reduce
healthcare costs.
Barts Cancer Institute (BCI), Queen Mary University of
London presented a poster on
19 March 2016 at the 10th ISMRC
International Symposium on Minimal Residual Cancer: Liquid Biopsy
in Cancer Diagnostics and Treatment in Hamburg.
Key conclusions from the BCI work include the following:
- The Parsortix system detected circulating tumour cells (CTCs)
in 100% of the metastatic prostate cancer patients.
- The patients with localised disease included patients with
early stage disease (determined by clinical investigation including
the Gleason score of solid tissues taken through invasive
procedures), where the decision had been taken that "active
surveillance" was appropriate rather than medical intervention.
Even for these earliest stage, indolent cancer patients, the
Parsortix system harvested CTCs that could be detected in 75% of
these patients.
- The Gleason score is currently the best parameter for assessing
aggressiveness of prostate cancer involving pathologist assessment
of the morphology of the cells obtained from the solid biopsy. The
number of mesenchymal CTCs harvested by the Parsortix system was
compared to the Gleason score for each of the patients and there
was found to be a good correlation suggesting that Parsortix liquid
biopsy may be able to provide the same or similar information as
the invasive solid biopsy in assessing the aggressiveness of the
cancer.
- The status of the patient – metastatic or localised – was
analysed against the number of mesenchymal CTCs harvested by the
Parsortix system. Separately the status of the patient – metastatic
or localised – was analysed against the patient's Gleason score.
Comparison of the results suggests that the Parsortix system may be
able to indicate the metastatic or localised status of the patient
with a higher level of accuracy than the Gleason score.
ANGLE now intends to work with BCI and other leading cancer
centres to develop and implement clinical studies to validate the
use of the Parsortix system as a clinical application in the
routine detection, assessment and treatment of prostate cancer
patients. The multi-centre clinical studies need to be
specified but would be expected to take at least 18 months to
complete.
Around 75% to 80% of men that have a solid prostate biopsy do
not have prostate cancer and of those that do have prostate cancer
more than half will be indolent (latent disease not causing harm to
the patient). Less than 10% of patients having a solid
prostate biopsy have aggressive prostate cancer requiring
treatment. Assuming the clinical studies confirm the recent patient
study results then ANGLE will be able to make clinical sales of the
Parsortix system as a non-invasive liquid biopsy alternative to the
solid prostate biopsy. Use of the Parsortix system would
avoid the medical complications of the solid prostate biopsy,
provide more reliable results in relation to detection of prostate
cancer, disease status and risk stratification, at the same time,
reduce healthcare costs and offer a faster, repeatable solution
enabling active surveillance where appropriate.
Dr Yong-Jie Lu, Reader in
Medical Oncology at Barts Cancer Institute, commented:
"The
Parsortix system enables investigation of the mesenchymal CTCs in
the patient blood and the results of our work to date suggests this
has the potential to become a non-invasive liquid biopsy for
prostate cancer. The exciting part of this research is the
potential for the Parsortix system to be used to assess the
severity of the disease as well as to detect it. This meets a
key medical need to avoid over-treatment as well as to ensure
treatment is available for patients who need it."
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"These are
highly encouraging results for the use of the Parsortix system for
a clinical application in prostate cancer. This opens the
potential of another highly differentiated liquid biopsy
application for Parsortix in a key area of medical need, which
cannot be addressed by ctDNA or antibody-based CTC systems, where
there is the potential to improve patient care and at the same time
reduce healthcare costs."
www.angleplc.com
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SOURCE ANGLE plc