Healthcare Industry News:  colorectal cancer 

Devices Interventional Oncology

 News Release - May 14, 2008

Sirtex Sponsors Pilot Study Evaluating SIR-Spheres(R) Microspheres for the Treatment of Unresectable Hepatocelluar Carcinoma

Study to evaluate safety and efficacy of microspheres on primary malignancy of the liver

WILMINGTON, Mass.--(HSMN NewsFeed)--Sirtex, a leading developer of targeted and innovative cancer therapies, announces the launch of a clinical trial evaluating the effect of treatment with SIR-Spheres® microspheres on the survival of patients with unresectable hepatocelluar carcinoma (HCC). Ravi Murthy, M.D., interventional radiologist with the University of Texas M.D. Anderson Cancer Center, and T. Clark Gamblin, M.D., surgical oncologist with the University of Pittsburgh Medical Center’s Liver Cancer Center, will serve as coordinating investigators for the study.

Sirtex received an investigational device exemption (IDE) from the FDA to conduct the trial. The trial is actively recruiting patients at Thomas Jefferson University’s Kimmel Cancer Center in Philadelphia, and the company expects to open patient recruitment at additional sites in the coming months.

SIR-Spheres microspheres are currently FDA approved for the treatment of unresectable metastatic liver tumors from primary colorectal cancer.1 Selective Internal Radiation Therapy (SIRT) using SIR-Spheres microspheres has been reported in a number of non-randomized trials to be effective and well tolerated in patients with unresectable HCC. Each year, over one million people are diagnosed with HCC, one of the leading causes of cancer-related mortality worldwide. Surgery is the most effective treatment option; however 90 percent of patients with HCC have tumors that cannot be surgically removed.

“SIR-Spheres microspheres have been used extensively in other parts of the world for the treatment of HCC. However in the United States, there is no FDA-approved microsphere therapy for this type of tumor,” says Dr. Samuel Putnam, medical director of U.S. operations for Sirtex. “The aim of this study is to further evaluate the safety and efficacy of microsphere therapy in patients with HCC, and ultimately help improve the level of care we are able to offer patients.”

A total of 40 participants will be enrolled over a period of 24 months. Eligible patients must be 18 years or older and have documented HCC disease confined to the liver. The primary objective of the study is to evaluate the effect of SIR-Spheres microspheres on survival rates in patients with HCC. The trial will also assess treatment safety, time-to-disease progression, health-related quality of life and tumor response to treatment.

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 Selective Internal Radiation Therapy (SIRT) using SIR-Spheres microspheres

Selective Internal Radiation Therapy (SIRT) is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumors. In a minimally-invasive treatment, millions of radioactive SIR-Spheres microspheres are infused via a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.

Clinical trials have confirmed that liver cancer patients treated with SIR-Spheres microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity, and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone.

SIR-Spheres microspheres are approved for use in Australia, the United States of America (FDA approval), and the European Union (CE Mark) and supplied in countries such as Hong Kong, Malaysia, Singapore, Thailand, Taiwan, India, Israel and Turkey with more than 7,500 patients having been treated to date.

For more information, visit www.sirtex.com.

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


Source: Sirtex

Issuer of this News Release is solely responsible for its content.
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