|By PR Newswire||
|March 24, 2014 10:54 AM EDT||
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 ,,. These recommendations were made with a Level of Evidence 1iiA and a Grade of Recommendation 1A in the European guidelines.
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. 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.
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
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
- 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.
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.
SYS-CON Events announced today that SUSE, a pioneer in open source software, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SUSE provides reliable, interoperable Linux, cloud infrastructure and storage solutions that give enterprises greater control and flexibility. More than 20 years of engineering excellence, exceptional service and an unrivaled partner ecosystem power the products and support that help ...
May. 30, 2015 11:00 AM EDT Reads: 770
SYS-CON Events announced today that MetraTech, now part of Ericsson, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Ericsson is the driving force behind the Networked Society- a world leader in communications infrastructure, software and services. Some 40% of the world’s mobile traffic runs through networks Ericsson has supplied, serving more than 2.5 billion subscribers.
May. 30, 2015 11:00 AM EDT Reads: 1,495
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
May. 30, 2015 11:00 AM EDT Reads: 1,573
The multi-trillion economic opportunity around the "Internet of Things" (IoT) is emerging as the hottest topic for investors in 2015. As we connect the physical world with information technology, data from actions, processes and the environment can increase sales, improve efficiencies, automate daily activities and minimize risk. In his session at @ThingsExpo, Ed Maguire, Senior Analyst at CLSA Americas, will describe what is new and different about IoT, explore financial, technological and re...
May. 30, 2015 11:00 AM EDT Reads: 668
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile ...
May. 30, 2015 11:00 AM EDT Reads: 5,497
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will addresses this very serious issue o...
May. 30, 2015 11:00 AM EDT Reads: 1,032
Cloud computing started a technology revolution; now DevOps is driving that revolution forward. By enabling new approaches to service delivery, cloud and DevOps together are delivering even greater speed, agility, and efficiency. No wonder leading innovators are adopting DevOps and cloud together! In his session at DevOps Summit, Andi Mann, Vice President of Strategic Solutions at CA Technologies, explored the synergies in these two approaches, with practical tips, techniques, research data, wa...
May. 30, 2015 11:00 AM EDT Reads: 6,659
paradigm shifts in networking, to cloud and licensure, and all the Internet of Things in between. In 2014 automation was the name of the game. In his session at DevOps Summit, Matthew Joyce, a Sales Engineer at Big Switch, will discuss why in 2015 it’s complexity reduction. Matthew Joyce, a sales engineer at Big Switch, is helping push networking into the 21st century. He is also a hacker at NYC Resistor. Previously he worked at NASA Ames Research Center with the Nebula Project (where OpenSta...
May. 30, 2015 11:00 AM EDT Reads: 635
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
May. 30, 2015 10:30 AM EDT Reads: 4,355
SYS-CON Events announced today that O'Reilly Media has been named “Media Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York City, NY. O'Reilly Media spreads the knowledge of innovators through its books, online services, magazines, and conferences. Since 1978, O'Reilly Media has been a chronicler and catalyst of cutting-edge development, homing in on the technology trends that really matter and spurring their adoption...
May. 30, 2015 10:30 AM EDT Reads: 879
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
May. 30, 2015 10:30 AM EDT Reads: 5,225
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not ...
May. 30, 2015 10:15 AM EDT Reads: 741
2015 predictions circa 1970: houses anticipate our needs and adapt, city infrastructure is citizen and situation aware, office buildings identify and preprocess you. Today smart buildings have no such collective conscience, no shared set of fundamental services to identify, predict and synchronize around us. LiveSpace and M2Mi are changing that. LiveSpace Smart Environment devices deliver over the M2Mi IoT Platform real time presence, awareness and intent analytics as a service to local connecte...
May. 30, 2015 10:00 AM EDT Reads: 662
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
May. 30, 2015 10:00 AM EDT Reads: 4,113
Thanks to widespread Internet adoption and more than 10 billion connected devices around the world, companies became more excited than ever about the Internet of Things in 2014. Add in the hype around Google Glass and the Nest Thermostat, and nearly every business, including those from traditionally low-tech industries, wanted in. But despite the buzz, some very real business questions emerged – mainly, not if a device can be connected, or even when, but why? Why does connecting to the cloud cre...
May. 30, 2015 09:45 AM EDT Reads: 737