LONDON, October 9, 2017 /PRNewswire/ --
Researchers from the UCL Cancer Institute and the specialist
healthcare company BTG plc (LSE: BTG) have begun the first clinical
trial of an experimental treatment for liver cancer using X-ray
imageable microscopic beads loaded with a targeted anti-cancer drug
placed directly in the liver. The trial will evaluate delivering a
precisely controlled dose of vandetanib, an inhibitor of multiple
tumour growth pathways, directly to the arteries feeding a liver
tumour by pre-loading the drug on a radiopaque bead which can be
visualised on CT scans. Although still at a very early stage of
research, the development programme aims to improve current
treatments for patients with primary liver cancer and metastatic
Colorectal Cancer (mCRC).
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The current standard of care for liver cancer patients is known
as transarterial chemoembolisation, or TACE, and involves injecting
beads through an artery using a microcatheter to block the
tumour-feeding blood vessels, starving the tumour of oxygen and
nutrients. These beads are usually loaded with a chemotherapy drug
that is released over time directly at the tumour site, avoiding
exposure to the rest of the body and reducing side effects. Despite
advances in this procedure, liver cancer remains one of the most
common causes of cancer death worldwide[i].
To improve the treatment of patients with primary liver cancer
and mCRC, the beads used in the VEROnA study (vandetanib-eluting
radiopaque beads in patients with resectable liver malignancies)
are pre-loaded with a multi-kinase inhibitor called vandetanib.
Vandetanib targets genetic alterations and cell-signalling pathways
that lead to liver cancer growth, recurrence and metastasis. These
pathways, including vascular endothelial growth factors (VEGF-A and
C) and epidermal growth factor receptor (EGFR), stimulate new
tumour blood and lymph vessel growth and aid the development of
solid tumours. They may also promote spread of the cancer to other
organs and inhibit the body's own immune response to the tumour. A
phase II trial of vandetanib in patients with advanced liver cancer
showed some promise[ii], and provided a strong rationale
for the loco-regional delivery of this drug.
Professor Ricky Sharma, Chair of
Radiation Oncology at University College London and the study's
primary investigator, said: "The incidence and mortality rates for
primary liver cancer continue to climb and it is vital that we
explore new treatment approaches. This research is exciting because
it is the first time we have been able to pre-load a targeted
cancer drug on to an imageable bead, to deliver the targeted drug
in high doses to the cancer and see exactly how well the beads
reach the target we have defined. By refining the treatment
using information from this clinical trial, we may be able to
develop a liver-directed treatment as a superior alternative to the
rather poorly tolerated drug treatments we currently offer patients
with this type of cancer."
The vandetanib-eluting bead was developed in collaboration with
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne,
Switzerland and Dr. Alban Denys, professor at the department of
medical radiology at CHUV. Vandetanib-eluting beads use BTG's
recently developed radiopaque bead platform.[iii] Beads
that can be visualised with CT or fluoroscopic imaging offer the
advantage of providing visible confirmation of bead location during
and after the embolisation procedure, enabling real-time
adjustments to optimise patient treatment[iv].
Melanie Lee, Chief Scientific
Officer at BTG said: "As leaders in Interventional Oncology, we are
continuing to pursue better solutions for patients through
innovation. Our suite of products are used to treat different stage
cancers and they are delivered into the cancer tumour in a very
targeted way, an approach called loco-regional therapy. This
programme is at a very early stage of research, but testing
vandetanib-eluting beads in man is an exciting milestone. Bringing
to market the first embolic beads visible under X-ray imaging has
enabled increased control and precision during treatment, and
adding a targeted anti-cancer agent we may be able to offer a new
option for hard to treat cancers in the liver."
The VEROnA study is sponsored by BTG and supported by the Cancer
Research UK Experimental Cancer Medicines Centre and the UCL Cancer
Institute and the National Institute for Health Research University
College London Hospitals Biomedical Research Centre. Patients
with primary liver cancer or mCRC who meet the eligibility criteria
will be offered participation in the clinical trial at University
College London Hospitals NHS Foundation Trust and the Royal Free
Hospital NHS Foundation Trust. Patients suitable for the
VEROnA study are those scheduled to have their liver tumours
removed surgically. By studying the resected tissue in great
detail, and comparing it to the scans performed before the
operation, researchers will be able to assess exactly where the
vandetanib-eluting beads have been deposited in and around the
tumours, and how much drug has been delivered to the target.
In this way, the VEROnA "window of opportunity" clinical
trial will assess the safety and tolerability of the new treatment
and the potential it offers for treating liver cancer.
About Liver Cancer:
Primary liver cancer occurs when liver cells become abnormal and
grow uncontrollably, forming a tumour. The most common form of
primary liver cancer is called hepatocellular carcinoma (HCC).
Liver cancer is the second leading cause of cancer deaths in the
world[v], and one of the most challenging to treat. Each
year, more than 700,000 patients worldwide are diagnosed with liver
cancer.[vi] Long-term infection with the hepatitis B or
hepatitis C virus, which are more prevalent in Asian countries, are
a common cause of cirrhosis and liver cancer. In developed
countries, increasing prevalence of obesity in the general
population and alcoholic liver disease account for the rising
incidence of HCC.
The liver, which continuously filters blood circulating through
the body, is also susceptible to "secondary" cancers, caused when
tumours in other organs such as the colon, rectum, breast, head or
neck have spread to the liver. These tumours are also known as
liver metastases. The liver is the most common site of metastasis
in patients with CRC. Approximately 50% of CRC patients will
develop liver metastases during the course of the
disease[vii].
About UCL
UCL (University College London) was founded in 1826. We were the
first English university established after Oxford and Cambridge, the first to open up university
education to those previously excluded from it, and the first to
provide systematic teaching of law, architecture and medicine. We
are among the world's top universities, as reflected by performance
in a range of international rankings and tables. UCL currently has
over 39,000 students from 150 countries and over 12,500 staff. Our
annual income is more than £1 billion
http://www.ucl.ac.uk | Follow us on Twitter
@uclnews | Watch our YouTube channel
YouTube.com/UCLTV
About UCL Cancer Institute
The UCL Cancer Institute is a £40 million investment in central
London based at University College
London (UCL), one of the world's top universities and a founding
member of the Crick Institute. UCL Cancer Institute draws together
over 300 scientists working together to develop world-class basic
and translational cancer research.
http://www.ucl.ac.uk/cancer | Follow us on Twitter
@uclcancer
About the National Institute for Health
Research
The National Institute for Health Research (NIHR): improving the
health and wealth of the nation through research.
Established by the Department of Health, the NIHR:
- funds high quality research to improve health
- trains and supports health researchers
- provides world-class research facilities
- works with the life sciences industry and charities to benefit
all
- involves patients and the public at every step
For further information, visit the NIHR website
(http://www.nihr.ac.uk).
About BTG
BTG is a global specialist healthcare company bringing to market
innovative products in specialist areas of medicine to better serve
doctors and their patients. We have a portfolio of Interventional
Medicine products to advance the treatment of cancer, severe
emphysema, severe blood clots and varicose veins, and Specialty
Pharmaceuticals that help patients overexposed to certain
medications or toxins. Inspired by patient and physician needs, BTG
is investing to expand its portfolio to address some of today's
most complex healthcare challenges.
To learn more about BTG, please visit: btgplc.com.
i. Ferlay, J., Soerjomataram, I., Dikshit, R., Eser, S.,
Mathers, C., Rebelo, M., Parkin, D. M., Forman, D. and Bray, F. (2015), Cancer incidence and
mortality worldwide: Sources, methods and major patterns in
GLOBOCAN 2012. Int. J. Cancer, 136: E359-E386.
doi:10.1002/ijc.29210.
ii. C. Hsu, et al. Vandetanib in patients with inoperable
hepatocellular carcinoma: a phase II, randomized, double-blind,
placebo-controlled study. J. Hepatol., 56 (5) (2012), pp.
1097-1103
iii. Preparation and Characterisation of Vandetanib-eluting
Radiopaque Beads for Locoregional Treatment of Hepatic
Malignancies. Hagan, A., Phillips, G.J., Lloyd, A.W., Czuczman, P.,
Lewis, A.L., Eur. J. Pharm. Sci., 101, 22-30, 2017.
iv. First Human Experience with Directly Image-able Iodinated
Embolization Microbeads. Levy, E.B., Krishnasamy, V.P., Lewis,
A.L., Willis, S., Macfarlane, C., Anderson, V., van der Bom, I.M.,
Radaelli, A., Dreher, M.R., Sharma, K.V., Negussie, A., Mikhail,
A., Geschwind, J.H., Wood, B.J., Cardiovasc. Intervent. Radiol.,
39(8), 1177-86, 2016.
v. World Health Organization (WHO). Cancer factsheet. Available
at: http://www.who.int/mediacentre/factsheets/fs297/en/ . Last
accessed 6 March, 2017.
vi. American Cancer Society. What are the key statistics about
liver cancer?. Available at:
http://www.cancer.org/cancer/livercancer/detailedguide/liver-cancer-what-is-key-statistics
. Last accessed 6 March, 2017.
vii. Nicolay NH, Berry DP, Sharma RA. Liver metastases from
colorectal cancer: role of radio-embolization with systemic
therapy. Nature Rev Clin Oncol
2009, 6: 687-697.
For further information contact:
BTG
Chris Sampson, Corporate
Communications Director
+44-20-7575-1595; Mobile: +44-7773-251-178
Ben Atwell/Simon Conway, FTI Consulting
+44(0)20-3727-1000
UCL Cancer Institute
Chris Lane, Media Relations
Manager
+44(0)20-3108-9222 Mobile: +44(0)7717-728-648
SOURCE BTG Plc
