|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.
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Jan. 18, 2017 01:30 AM EST Reads: 4,190
WebRTC is about the data channel as much as about video and audio conferencing. However, basically all commercial WebRTC applications have been built with a focus on audio and video. The handling of “data” has been limited to text chat and file download – all other data sharing seems to end with screensharing. What is holding back a more intensive use of peer-to-peer data? In her session at @ThingsExpo, Dr Silvia Pfeiffer, WebRTC Applications Team Lead at National ICT Australia, looked at differ...
Jan. 18, 2017 01:15 AM EST Reads: 4,857
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
Jan. 18, 2017 01:00 AM EST Reads: 6,041
"Splunk basically takes machine data and we make it usable, valuable and accessible for everyone. The way that plays in DevOps is - we need to make data-driven decisions to delivering applications," explained Andi Mann, Chief Technology Advocate at Splunk and @DevOpsSummit Conference Chair, in this SYS-CON.tv interview at @DevOpsSummit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 18, 2017 01:00 AM EST Reads: 2,002
"Logz.io is a log analytics platform. We offer the ELK stack, which is the most common log analytics platform in the world. We offer it as a cloud service," explained Tomer Levy, co-founder and CEO of Logz.io, in this SYS-CON.tv interview at DevOps Summit, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 18, 2017 12:45 AM EST Reads: 6,238
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
Jan. 18, 2017 12:45 AM EST Reads: 5,938
In his session at @DevOpsSummit at 19th Cloud Expo, Robert Doyle, lead architect at eCube Systems, will examine the issues and need for an agile infrastructure and show the advantages of capturing developer knowledge in an exportable file for migration into production. He will introduce the use of NXTmonitor, a next-generation DevOps tool that captures application environments, dependencies and start/stop procedures in a portable configuration file with an easy-to-use GUI. In addition to captur...
Jan. 18, 2017 12:30 AM EST Reads: 2,774
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 18, 2017 12:00 AM EST Reads: 2,253
Due of the rise of Hadoop, many enterprises are now deploying their first small clusters of 10 to 20 servers. At this small scale, the complexity of operating the cluster looks and feels like general data center servers. It is not until the clusters scale, as they inevitably do, when the pain caused by the exponential complexity becomes apparent. We've seen this problem occur time and time again. In his session at Big Data Expo, Greg Bruno, Vice President of Engineering and co-founder of StackIQ...
Jan. 18, 2017 12:00 AM EST Reads: 7,728
One of the hottest areas in cloud right now is DRaaS and related offerings. In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.
Jan. 17, 2017 11:30 PM EST Reads: 4,307
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of D...
Jan. 17, 2017 11:15 PM EST Reads: 4,885
In 2014, Amazon announced a new form of compute called Lambda. We didn't know it at the time, but this represented a fundamental shift in what we expect from cloud computing. Now, all of the major cloud computing vendors want to take part in this disruptive technology. In his session at 20th Cloud Expo, John Jelinek IV, a web developer at Linux Academy, will discuss why major players like AWS, Microsoft Azure, IBM Bluemix, and Google Cloud Platform are all trying to sidestep VMs and containers...
Jan. 17, 2017 11:00 PM EST Reads: 532
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Jan. 17, 2017 10:30 PM EST Reads: 694
The many IoT deployments around the world are busy integrating smart devices and sensors into their enterprise IT infrastructures. Yet all of this technology – and there are an amazing number of choices – is of no use without the software to gather, communicate, and analyze the new data flows. Without software, there is no IT. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Dave McCarthy, Director of Products at Bsquare Corporation; Alan Williamson, Principal ...
Jan. 17, 2017 10:30 PM EST Reads: 2,341
DevOps and microservices are permeating software engineering teams broadly, whether these teams are in pure software shops but happen to run a business, such Uber and Airbnb, or in companies that rely heavily on software to run more traditional business, such as financial firms or high-end manufacturers. Microservices and DevOps have created software development and therefore business speed and agility benefits, but they have also created problems; specifically, they have created software securi...
Jan. 17, 2017 09:30 PM EST Reads: 1,770