Sirtex Supports Clinical Trial Evaluating SIR-Spheres(R) Microspheres for First Line Treatment of Liver Cancer

Sirtex, a leading developer of targeted and innovative cancer therapies, is pleased to announce its support of a clinical trial evaluating SIR-Spheres microspheres at the Goshen Cancer Institute at Goshen Health System in Goshen, Ind. The trial will evaluate the efficacy of Sirtex’s SIR-Spheres microspheres and chemotherapy as a first-line treatment for patients with colorectal cancer that has metastasized to the liver. Seza Gulec, M.D., F.A.C.S., Director of the Goshen Cancer Institute’s Hepatic Oncology Program is the principle investigator for the study.

SIR-Spheres microspheres are the only FDA-approved microsphere therapy for non-resectable colorectal cancer that has spread to the liver.1 Microsphere therapy is typically used as a later stage treatment for patients who have failed or stopped responding to first line treatments. Dr. Gulec and his team are investigating the use of SIR-Spheres microspheres with the chemotherapy regimens Folfox-6 and FOLFIRI as a first line therapy for colon cancer patients with liver metastases under an IRB approved protocol.

“This trial signals a significant shift in treating advanced liver cancer,” says Seza Gulec, M.D. “Although SIR-Spheres microspheres are often used in conjunction with chemotherapy, the treatment is usually offered as a second or third option when the disease is more advanced. Through clinical trials such as this, our goal is to provide the safety and efficacy data needed to be able to offer SIR-Spheres microspheres as an option to patients earlier in their treatment process.”

Approximately 20 patients will be enrolled in the initial phase of the study. Patient recruitment for the trial began in January 2006 and is expected to continue through next year. Participants receive chemotherapy on the first day of treatment and SIR-Spheres microspheres on the next day. Patients are followed at regular intervals with laboratory evaluations and PET/CT imaging to assess response to treatment.

Sirtex’s SIR-Spheres microspheres are radioactive polymer spheres that emit yttrium 90 beta radiation. Physicians insert a catheter through the groin into the hepatic artery and deliver millions of SIR-Spheres microspheres directly to the tumor site. Approximately 60 physicians in the United States use Sirtex’s SIR-Spheres microspheres in more than 55 medical centers. The minimally invasive procedure is performed on an out-patient basis with minor side effects.

For more information on the trial, please contact Goshen Cancer Institute Hepatic Oncology Clinical Coordinator Heather Atkinson, RN at (574) 535-2573 or e-mail hatkinso@goshenhealth.com.

1 Sirtex Medical Inc.’s SIR-Spheres® microspheres are indicated for the treatment of non-resectable metastatic colorectal cancer in combination with intra-arterial FUDR chemotherapy. Information regarding other disease states or agents in combination with this device that is presented in peer reviewed literature is different from the approved USA labeling for SIR-Spheres.

About Sirtex

SIR-Spheres microspheres were developed in the 1980s in Australia and were approved by the FDA in March 2002. Sirtex has obtained regulatory approval to market SIR-Spheres microspheres in the United States, European Union, Israel and Australia. The product is marketed in New Zealand, Hong Kong, Malaysia, Singapore and Thailand. For more information, visit www.sirtex.com.

® SIR-Spheres is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd