Sirtex completes recruitment for SIRFLOX study

Sirtex Medical (ASX:SRX) has completed recruitment for the long-running clinical trial of its SIR-Spheres liver cancer treatment in metastatic colorectal cancer (mCRC).

All 450 patients have been enrolled in the SIRFLOX study and the company now expects to be able to publish primary results in 2014.

The SIRFLOX study launched in 2006. It is a randomised, controlled trial to assess whether using SIR-Spheres in addition to standard chemotherapy regimens is more effective than chemotherapy alone in treating liver metastasises from mCRC.

Sirtex CEO Gilman Wong said the study is the largest ever randomised controlled trial in the field of interventional oncology.

“The completion of patient recruitment onto the SIRFLOX study has required the participation of more than 100 leading hospitals globally and considerable resources over six years,” he said.

While Sirtex has been marketing SIR-Spheres for over a decade - the products have been approved for sale in Australia, Europe and the US - the company believes that take-up as a first-line treatment has been limited by the lack of clinical data compared to standard chemotherapy regimens.

“We believe that 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 and leading to a step-change in Sirtex’s business,” said Wong.

SIR-Spheres microspheres deliver targeted doses of radiation therapy directly to cancer cells. They are inserted into a tumour’s blood supply.

Sirtex shares were trading 0.58% lower at $10.29 just before market close on Friday.