Sirtex Medical Limited, a global life sciences applied to marketed SIR-Spheres microspheres, targeted radiation therapy for patients with liver tumours inoperable primary or secondary, and Guerbet SA have initiated a collaboration in clinical studies of primary and secondary liver cancer (metastatic).
The goal of the collaboration is to examine how the SIR-Spheres microspheres of Sirtex and Lipiodol Guerbet can be combined or sequenced optimally and continue to develop to address the unmet clinical need in patients with hepatocellular carcinoma, metastatic colorectal cancer, tumours metastatic neuroendocrine and different types of primary and secondary liver cancers.
Sirtex chief executive officer Gilman Wong said: "The shared vision of Sirtex and Guerbet is that one day, instead of terminally ill patients Porla unfortunately die, liver cancer can be considered a chronic disease with which patients can live well. since I am Sirtex have been fortunate to meet a number of patients who have survived his liver cancer for many years following treatment with SIR-Spheres microspheres. hope that through this collaboration are achieved clinical studies improvements for the benefit of patients with liver cancer. If the initial collaboration proves fruitful future collaborations in R&D and marketing between our companies should be considered. "
The SIR-Spheres microspheres used Sirtex in selective internal radiation therapy (SIRT), also known as radioembolisation, for the treatment of patients with inoperable liver tumours. In randomised controlled trials (RCT) SIR spheres microspheres have been shown to increase survival in patients with unresectable liver metastases from primary colorectal cancer. SIR-Spheres microspheres are currently being evaluated in six international multicentre RCT in metastatic colorectal cancer (mCRC) and hepatocellular carcinoma (HCC), which cumulatively recruit more than 2,100 patients. The first of these RCT, the SIRFLOX study completed enrolling patients in April 2013 and is expected to report its findings in early 2015.
Lipiodol Ultra Fluid used Guerbet conventional procedures transarterial chemoembolisation (cTACE) for the treatment of patients with inoperable liver tumours. Over 100 clinical studies have been published on the cTACE, of which 12 were international RCT, with a total of more than 10,000 patients with intermediate stage HCC have been reported in peer-reviewed scientific literature. Recently, cTACE has been established as the standard treatment for patients with intermediate stage HCC in three international clinical consensus guidelines in Japan, Europe and the United States. These consensus guidelines recommend unanimously cTACE as the standard treatment for patients with intermediate stage HCC These recommendations were made with a Level of Evidence grade 1iiA and 1A Recommendation in European guidelines
The chief executive officer ,Guerbet, Dr. Yves L'Epine, said. "We are thrilled about the potential of combining or sequencing products to enhance the effectiveness of interventional radiology procedures in patients with unresectable liver tumours In fact, the Lipiodol and SIR-Spheres are individually proven and widely used therapies, have never been examined together or sequentially.'s Master Clinical Research Collaboration Agreement to be executed between our companies will provide the framework from which to launch a series of clinical projects investigating innovative ways of using Lipiodol and SIR-Spheres in patients with inoperable liver tumours. "
The Master Clinical Research Collaboration Agreement to bring both capabilities companies considerable internal clinical development and proactively focus efforts in areas of unmet medical needs.
The first project under the Agreement consists in a series of clinical studies designed to evaluate the potential for synergy between the two therapies and whether therapies can be combined or sequenced in a way that provides an optimised tumour control.
The selective internal radiation therapy (SIRT) is a minimally invasive procedure where an interventional radiologist uses a catheter placed in (the main artery that supplies blood to the liver) hepatic artery to supply the SIR-Spheres microspheres directly to tumours liver. SIR-Spheres microspheres, containing the radioactive element yttrium-90, are housed in the small blood vessels that supply the tumours in the liver, where high doses of radiation are released directly to tumours. Since the SIR-Spheres microspheres are delivered directly to tumours, it is possible for patients to receive higher doses of radiation than with external beam radiotherapy traditional
SIR-Spheres microspheres are approved by FDA and the PMA are indicated in the US for the treatment of metastatic liver tumours unresectable primary colorectal cancer in combination with chemotherapy using hepatic arterial floxuridine. SIR-Spheres microspheres are also approved for use in the European Union (CE Mark), Switzerland, Israel , Australia , New Zealand and many other countries for the treatment of unresectable primary or secondary liver tumours
The conventional transarterial chemo-embolisation (cTACE) is a minimally invasive procedure that involves combining Lipiodol Ultra Fluid with an anticancer drug and inject this transarterialmente treatment in the liver as a loco-regional chemotherapy, in which Lipiodol Ultra Fluid acts as a contrast agent, a releasing drug vehicle and transient embolic arterio-site cTACE was first performed in Japan in 1982 and then introduced and effectively used in Asia , Europe, Middle East and Africa, and North America.
Lipiodol Ultra Fluid was initially developed for radiological diagnostic indications including diagnosis of liver lesions, hysterosalpingography and lymphography and then used in interventional radiology procedures conventional transarterial chemo-embolisation (cTACE) of multinodular hepatocellular carcinoma, where Lipiodol Ultra Fluid was used as a display for the procedure (contrast agent) a drug vehicle (carrier and drug-eluting), and embolic. The approved indications for Lipiodol may vary by country.
As a pioneer in the field of contrast agents with over 80 years experience, Guerbet is the only pharmaceutical group fully dedicated to medical imaging worldwide.