Repeated Treatments of SIR-Spheres® Microspheres Appear to be Safe for Patients with Metastatic Liver Tumors

Wednesday 17 January 2007
Retrospective Analysis Presented at the 2007 American Society of Clinical Oncology Gastrointestinal Cancers Symposium

LAKE FOREST, Ill. (January 17, 2007) – New data on Sirtex’s SIR-Spheres® microspheres will be presented at the 2007 American Society of Clinical Oncology (ASCO) Gastrointestinal Symposium. The meeting will be held Jan. 19-21 at the Orlando World Center Marriott in Orlando, Fla. Andrew Kennedy, M.D., F.A.C.R.O., co-medical director of Wake Radiology Oncology in Cary, N.C., will present a poster session reporting the findings of a new retrospective analysis evaluating liver tolerance to repeated doses of radiation from SIR-Spheres microspheres (90Y-microspheres). Sirtex’s SIR-Spheres microspheres are the only FDA-approved microsphere therapy for liver tumors that originate in the colon or rectum.

“We have been able to successfully treat patients with SIR-Spheres microspheres with favorable results,” says Kennedy. “However, liver tolerance to repeated treatments with SIR-Spheres microspheres due to tumor progression, or new tumor presentation, was unknown at the time. Based on this analysis, we are encouraged to report that patients with advanced liver tumors can be safely retreated with microsphere therapy, without damaging the normal liver.”

Dr. Kennedy and his team analyzed the data taken from 38 patients treated with SIR- Spheres microspheres. Tumor types treated include: 12 carcinoid, 11 colorectal, six hepatocellular and cholangiocarcinomas, two sarcomas, three unknown primary tumors and one each of breast, esophagus, and head and neck primary tumors.1

Thirty-three patients received two courses of SIR-Spheres microspheres and five patients received three courses of therapy. Liver functions were stable in all patients after additional liver radiation, and no patients developed radiation-induced liver dysfunction (RILD) or veno-occlusive disease (VOD). According to Dr. Kennedy, no specific dose reduction is recommended for retreatment of the liver.

“This analysis provides critical clinical information concerning retreating patients with SIR-Spheres microspheres,” says Nat Geissel, CEO, Sirtex Medical Inc. “Sirtex is committed to supporting research, such as Dr. Kennedy’s, that adds to the growing body of safety and efficacy data on SIR-Spheres microspheres.”

Sirtex’s SIR-Spheres microspheres are radioactive polymer spheres that emit 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 65 medical centers. The minimally invasive procedure is performed on an out-patient basis with minor side effects.

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 microspheres.

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 Medical Limited

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