Welcome!

News Feed Item

Sirtex and Guerbet to Collaborate on Clinical Studies in Primary and Secondary Liver Cancer

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

  1. Japan Society of Hepatology, Recommendation, Chapter 5 (CQ44, page 105); Hepatology Research 2010; 40 (Suppl.1): 96-112.
  2. 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.
  3. AASLD Practice Guidelines; American Association for Study of the Liver Diseases; HEPATOLOGY, Vol. 53, No. 3, 2011.
  4. 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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, provided a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to oper...
Sometimes I write a blog just to formulate and organize a point of view, and I think it’s time that I pull together the bounty of excellent information about Machine Learning. This is a topic with which business leaders must become comfortable, especially tomorrow’s business leaders (tip for my next semester University of San Francisco business students!). Machine learning is a key capability that will help organizations drive optimization and monetization opportunities, and there have been some...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
"Storpool does only block-level storage so we do one thing extremely well. The growth in data is what drives the move to software-defined technologies in general and software-defined storage," explained Boyan Ivanov, CEO and co-founder at StorPool, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
As Marc Andreessen says software is eating the world. Everything is rapidly moving toward being software-defined – from our phones and cars through our washing machines to the datacenter. However, there are larger challenges when implementing software defined on a larger scale - when building software defined infrastructure. In his session at 16th Cloud Expo, Boyan Ivanov, CEO of StorPool, provided some practical insights on what, how and why when implementing "software-defined" in the datacent...
Blockchain. A day doesn’t seem to go by without seeing articles and discussions about the technology. According to PwC executive Seamus Cushley, approximately $1.4B has been invested in blockchain just last year. In Gartner’s recent hype cycle for emerging technologies, blockchain is approaching the peak. It is considered by Gartner as one of the ‘Key platform-enabling technologies to track.’ While there is a lot of ‘hype vs reality’ discussions going on, there is no arguing that blockchain is b...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Is advanced scheduling in Kubernetes achievable?Yes, however, how do you properly accommodate every real-life scenario that a Kubernetes user might encounter? How do you leverage advanced scheduling techniques to shape and describe each scenario in easy-to-use rules and configurations? In his session at @DevOpsSummit at 21st Cloud Expo, Oleg Chunikhin, CTO at Kublr, answered these questions and demonstrated techniques for implementing advanced scheduling. For example, using spot instances and co...
The use of containers by developers -- and now increasingly IT operators -- has grown from infatuation to deep and abiding love. But as with any long-term affair, the honeymoon soon leads to needing to live well together ... and maybe even getting some relationship help along the way. And so it goes with container orchestration and automation solutions, which are rapidly emerging as the means to maintain the bliss between rapid container adoption and broad container use among multiple cloud host...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
Imagine if you will, a retail floor so densely packed with sensors that they can pick up the movements of insects scurrying across a store aisle. Or a component of a piece of factory equipment so well-instrumented that its digital twin provides resolution down to the micrometer.