SYDNEY and VILLEPINTE,
France, March 24, 2014 /PRNewswire/ --
Sirtex Medical Limited (ASX:SRX) and Guerbet S.A. (EPA:GBT)
announce today that the two companies will enter into a major
clinical studies collaboration in primary and secondary
(metastatic) liver cancer. The objective of the collaboration is to
examine how Sirtex's SIR-Spheres® microspheres and
Guerbet's Lipiodol® may be combined or sequenced
optimally - and further developed - to address the significant
unmet clinical need in patients with hepatocellular carcinoma,
metastatic colorectal cancer, metastatic neuroendocrine tumours,
and a range of other primary and secondary liver cancers.
Sirtex's Chief Executive Officer, Mr Gilman Wong said that
"Sirtex's and Guerbet's shared vision is that one day, rather than
being a terminal disease that patients unfortunately die from,
liver cancer may be considered a chronic disease that patients can
successfully live with. During my time at Sirtex I have been
fortunate to meet a number of patients who have survived their
liver cancer for many years following treatment with SIR-Spheres
microspheres. We hope through this clinical studies collaboration
to make further gains for the benefit of the patients afflicted by
liver cancer. Should the initial collaboration prove fruitful,
future collaborations in R&D and marketing between our
respective companies may be considered".
Sirtex's SIR-Spheres microspheres are used in selective internal
radiation therapy (SIRT), also known as radioembolisation, for the
treatment of patients with inoperable liver tumours. SIR-Spheres
microspheres have been shown in randomised controlled trials (RCTs)
to increase survival in patients with inoperable liver metastases
from primary colorectal cancer. SIR-Spheres microspheres are
currently being evaluated in six international, multi-centre RCTs
in metastatic colorectal cancer (mCRC) and hepatocellular carcinoma
(HCC), which cumulatively will enrol in excess of 2,100 patients.
The first of these RCTs, the SIRFLOX study, completed patient
enrolment in April 2013 and is
expected to report its results in early 2015.
Guerbet's Lipiodol® Ultra Fluid is used in
conventional trans-arterial chemo-embolisation (cTACE) procedures
for the treatment of patients with inoperable liver tumours. cTACE
has been published in over 100 clinical studies, of which 12 were
international RCTs, out of a total number of more than 10,000
patients with intermediate stage HCC who have been reported on in
the peer-reviewed scientific literature. Recently, cTACE has been
established as the standard-of-care for the treatment of patients
with intermediate stage HCC by three international clinical
consensus guidelines in Japan,
Europe and the United States. These consensus guidelines
unanimously recommend cTACE as the standard-of-care for patients
with intermediate stage HCC
[1],[2],[3].
These recommendations were made with a Level of Evidence 1iiA and a
Grade of Recommendation 1A in the European
guidelines[2].
Guerbet's Chief Executive Officer, Dr Yves L'Epine, said "We are
excited about the potential of combining or sequencing our products
to improve the efficacy of Interventional Radiology procedures in
patients with unresectable hepatic tumours. Indeed, while Lipiodol
and SIR-Spheres individually are well proven and widely used
therapies in their own right, they have never been formally
evaluated together or sequentially. A Master Clinical Research
Collaboration Agreement to be executed between our companies will
provide the framework from which to launch a number of clinical
projects investigating innovative ways to employ Lipiodol and
SIR-Spheres in patients with inoperable liver tumours".
The Master Clinical Research Collaboration Agreement will bring
together the two companies' considerable internal clinical
development capabilities and proactively focuses efforts on areas
of high unmet medical needs.
The first project under the Agreement will consist of a series
of clinical studies designed to evaluate the potential for
synergism between the two therapies and whether the therapies may
be combined or sequenced in a manner that delivers optimised tumour
control.
What is SIRT?
Selective internal radiation therapy (SIRT) is a minimally
invasive procedure, in which an Interventional Radiologist uses a
catheter placed in the hepatic artery (the main artery supplying
blood to the liver)to deliver SIR-Spheres microspheres directly to
tumours in the liver. The SIR-Spheres microspheres, which contain
the radioactive element yttrium-90, lodge in the small blood
vessels that supply the tumours in the liver, where they deliver
high doses of radiation directly to the tumours. Because
SIR-Spheres microspheres are delivered directly to the tumours,
patients may receive radiation doses many times higher than
possible with traditional external beam radiation therapy.
About SIR-Spheres microspheres
Manufactured by Sirtex Medical Limited, SIR-Spheres microspheres
are PMAFDA approved and are indicated in the United States for the treatment of
non-resectable metastatic liver tumours from primary colorectal
cancer in combination with hepatic arterial chemotherapy using
floxuridine. SIR-Spheres microspheres are also approved for use in
the European Union (CE Mark), Switzerland, Israel, Australia, New
Zealand, and several other countries for the treatment of
unresectable primary or secondary liver tumours.
What is cTACE?
Conventional trans-arterial chemo-embolisation (cTACE) is a
minimally invasive procedure which consists of mixing
Lipiodol® Ultra Fluid with an anticancer drug and
injecting this treatment trans-arterially in the liver as a
loco-regional targeted chemotherapy, in which Lipiodol®
Ultra Fluid acts as a contrast agent, a drug eluting vehicle and a
dual arterio-portal transient
embolic[4]. cTACE was first
performed in Japan in 1982 and
then introduced and used effectively throughout Asia, Europe,
the Middle East and Africa, as well as North America.
About Lipiodol®
Ultra Fluid
Lipiodol® Ultra Fluid was initially developed for
Diagnostic Radiology in indications including liver lesion
diagnosis, lymphography and hysterosalpingography and then used in
Interventional Radiology for conventional trans-arterial
chemo-embolisation (cTACE) procedures of multinodular
hepatocellular carcinoma, where Lipiodol® Ultra Fluid
was used as a procedure visualiser (contrast agent), a drug vehicle
(drug carrier and eluter), and an embolic. The approved indications
for Lipiodol® may vary according to countries. Please
refer to local SmPC for further information.
About Sirtex
Sirtex is a global life-sciences company that markets
SIR-Spheres microspheres, a targeted radiation therapy for patients
with inoperable primary or secondary (metastatic) liver tumours.
Sirtex has supplied over 40,000 doses of SIR-Spheres microspheres
to 600 centres in over 30 countries worldwide. Current research
involving novel small particle technologyand radio-protector
technologies are two areas of focus amongst an expanding portfolio
of products designed to offer cancer patients treatment options in
the management of their disease. Sirtex devotes significant
resourcesto the future growth of the company with approximately 23%
of $100 million in sales for 2013
invested in research and development and clinical studies. Sirtex
(SRX) is listed on the Australian Stock Exchange. For additional
information about Sirtex, please go to
http://www.sirtex.com
About Guerbet
A pioneer in the field of contrast agents with more than 80
years of experience, Guerbet is the only pharmaceutical group fully
dedicated to medical imaging worldwide. As such it has a complete
offering of contrast products for X-ray and MRI and for
Interventional Radiology, along with a range of injectors and
related medical equipment to provide improved diagnosis and
treatment of patients. To promote the discovery of new products and
assure future growth, Guerbet devotes significant resources to
research and development every year (approximately 10% of sales).
Guerbet (GBT) is listed on the NYSE Euronext Paris (Eurolist
Segment B - Mid Caps) and had sales of €390 million in 2013 with a
total workforce of 1,485 employees. For additional information
about Guerbet please go to http://www.guerbet.com
References
- Japan Society of Hepatology, Recommendation, Chapter 5 (CQ44,
page 105); Hepatology Research 2010; 40 (Suppl.1): 96-112.
- EASL-EORTC Clinical Practice Guidelines: Management of
hepatocellular carcinoma; European Association of Study of Liver
Disease & European Organization for Research and Treatment of
Cancer); Journal of Hepatology 2012 vol. 56 j 908-943.
- AASLD Practice Guidelines; American Association for Study of
the Liver Diseases; HEPATOLOGY, Vol. 53, No. 3, 2011.
- Kan et All, Seminars in Interventional Radiology 2008; 25 (2):
7785
SIR-Spheres® is a registered trademark of Sirtex
SIR-Spheres Pty Ltd.
Lipiodol® Ultra-Fluid is a registered trademark of
GUERBET SA.
Forward-looking statements
This press release may contain
forward-looking statements based on current assumptions and
forecasts made by Sirtex and Guerbet management. Various known and
unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial
situation, development or performances of the company and the
estimates given here. These factors include those discussed in
Sirtex and Guerbet's public reports which are available on the
Sirtex and Guerbet websites at http://www.sirtex.com and
http://www.guerbet.com. The companies assume no liability
whatsoever to update these forward-looking-statements or to conform
them to future events or developments.
