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Bayer and Onyx Begin Enrollment in STORM Trial Studying Nexavar as Adjuvant Therapy for Patients With Liver Cancer
Date:8/21/2008

me to recurrence, patient-reported outcomes, plasma biomarkers, safety and tolerability.

The study is enrolling patients with all HCC histologies. Patients will be randomized to receive 400 mg of Nexavar twice daily or matching placebo for up to four years. The study will be conducted at more than 200 sites in North America, South America, Europe and the Asia-Pacific region, including Japan. For information about enrolling in the study, please visit http://www.clinicaltrials.gov.

Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year (more than 400,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in the United States) and the incidence is increasing. In 2002, approximately 600,000 people died of liver cancer including approximately 370,000 in China, South Korea and Japan, 57,000 in the European Union, and 13,000 in the United States.(1,2)

Currently there are no adjuvant treatments with proven benefit in HCC and half of the patients who have undergone surgical resection or local ablation will see their tumors return within three years and 70 percent will see their tumors return within five years.(3)

Nexavar's Differentiated Mechanism

Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is currently approved in m
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SOURCE Onyx Pharmaceuticals, Inc.; Bayer HealthCarePharmaceuticals, Inc.
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