500-plus Patient Study Aimed At Expanding Use of Targeted Liver Cancer Therapy Called SIR-Spheres Microspheres as a First-Line Treatment for Colorectal Liver Metastases
Sydney, Australia – 15 April 2013 – Australian-based global oncology company, Sirtex Medical Limited (ASX: SRX), has announced the completion of patient recruitment for its global SIRFLOX clinical study which is aimed at expanding the clinical use of its SIR-spheres® microspheres targeted radiation therapy from a last line medical treatment to a standard first-line oncology therapy.
The SIRFLOX study is expected to deliver its primary results in late 2014. The study aims to evaluate whether a first-line treatment strategy of standard-of-care chemotherapy plus SIR-Spheres® microspheres is more effective in delaying cancer progression than chemotherapy alone, in patients with inoperable liver metastases from primary colorectal cancer. Completing recruitment into the study required the participation of more than 100 leading hospitals globally over a six year period. The primary end point of the study is progression-free survival (PFS).
Global Principal Investigator and Consultant Medical Oncologist at The Royal Melbourne Hospital, Professor Peter Gibbs, commented:
“Over the past decade we have seen mostly incremental improvements in the treatment options for patients with advanced colorectal cancer. Clinicians and their patients need new options and the results of the SIRFLOX study will be eagerly anticipated.”
Sirtex Chief Executive Officer Gilman Wong said:
“Sirtex is committed to delivering the Level one clinical evidence from large randomised controlled trials confirming the effectiveness of SIR-Spheres microspheres. We believe if the results from the SIRFLOX study are positive, SIR-Spheres microspheres will be elevated to a first-line therapy for patients with colorectal liver metastases, providing important clinical benefits to patients worldwide and leading to a step-change in Sirtex’s business.”
Gilman Wong continued:
“Sirtex has been marketing SIR-Spheres microspheres for over a decade and while we have an established position as a last-line salvage therapy, many more patients may benefit from selective internal radiation therapy (SIRT) with SIR-Spheres microspheres once it is elevated to a first-line treatment option. We are very pleased to have completed patient recruitment and we wish to thank the patients, physician investigators and research staff involved in SIRFLOX for their participation in this landmark clinical study.”
Notes to Editors
Sirtex Medical Limited (Sirtex) is an Australian company with an approved cancer treatment supplied globally. Sirtex’s main commercialised product is a targeted radioactive treatment for liver cancer called SIR-Spheres® microspheres. Approximately 30,000 doses of SIR-Spheres microspheres have been supplied to treat liver cancer patients in over 580 medical centres in over 27 countries. This product has approval from the US Food & Drug Administration (FDA), the European Union (CE Mark) and Australia’s Therapeutic Goods Administration (TGA). Sirtex has manufacturing capabilities in the US, Singapore and Australia. SIR-Spheres microspheres dose sales currently represent less than one per cent of the total addressable market of metastatic colorectal cancer (mCRC) and hepatocellular carcinoma (HCC). For more information: www.sirtex.com.au
What are SIR-Spheres microspheres and how are they used?
SIR-Spheres microspheres are used to deliver targeted internal radiation therapy directly to liver tumours via the hepatic artery. This therapy is called Selective Internal Radiation Therapy (SIRT) and is performed using minimally invasive surgical techniques by an interventional radiologist. SIR-Spheres microspheres are used in primary liver cancer (hepatocellular carcinoma) and secondary liver cancer (metastatic liver cancer), where the tumour has originated from another part of the body but has spread to the liver. Where SIR-Spheres microspheres are used, the available clinical evidence suggests SIR-Spheres microspheres may approximately double the rate of tumour shrinkage and tumour remission. The evidence also suggests it may be capable of improving the life expectancy of patients by between 35 per cent and 100 per cent compared to standard treatment.
SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd.