Sirtex completes SIRFLOX trial

Sirtex Medical (ASX:SRT) has completed a trial of its SIR-Spheres microspheres in inoperable liver cancer and decided to expand a trial in kidney cancer to higher radiation doses.

Final reconciliation of the data from the company’s SIRFLOX trial in liver cancer is now underway. This will involve an initial analysis of the study background and safety data and verification of the data.

The company expects the reconciliation to be completed by mid-March next year, and that the database for the trial will be locked on that date. Sirtex aims to be able to confirm whether the trial met its primary endpoint one week later.

Sirtex said if the results are confirmed as positive, it could be the impetus for SIR-Spheres to be elevated into first-line therapy for patients with colorectal liver metastases.

The separate RESIRT trial of SIR-Spheres in renal cell carcinoma has completed recruitment up to the highest radiation dose level originally planned - 200 Gy.

Because no toxicity has been reported in the 12 patients, including the three at the highest dose level, the investigators will now expand the study to recruit patients at higher dose levels.

This marks the first time in the world SIR-Spheres are being trialled in cancers outside the liver.

Sirtex is meanwhile recruiting patients for its FOXFIRE Global study, which aims to evaluate whether a first-line treatment strategy of using standard-of-care chemotherapy plus SIR-Spheres microspheres is more effective than chemotherapy alone in inoperable liver metastases.

The company expects to complete recruitment during Q1 of 2015. Another trial to evaluate whether SIR-Spheres are more effective than standard of care sorafenib in patients with inoperable hepatocellular carcinoma is expected to complete recruitment by the end of the year.

Sirtex Medical (ASX:SRX) shares were trading 0.63% higher at $22.50 as of around 2.30 pm on Monday.