Onyx and Bayer Preparing for Liver Cancer Trial of Nexavar

By Alice Turner
22:25, August 21st 2008
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Onyx and Bayer Preparing for Liver Cancer Trial of Nexavar

Although already approved for treatment of advanced hepatocellular carcinoma, Nexavar will be the subject of a late stage trial aimed at approving the promising drug as a post-surgery treatment for liver cancer. The trial, called STORM, will enroll around 1,100 patients, who will receive either two 400-milligram Nexavar tablets per day, or a placebo, for up to four years.

Last November, The US Food and Drug Administration had approved a previously "Fast Track"-designated drug for treatment of advanced hepatocellular carcinoma (primary liver cancer). The drug improved overall survival by 44 percent among people with HCC in clinical testing, which was considered a major discovery against one of the most voracious diseases. The drug was already approved for advanced renal cell carcinoma (primary kidney cancer since 2005.

Diarrhea and hand/foot skin reactions were the most common side effects experienced by those patients who received the drug. In January, it was revealed that patients taking Nexavar (sorafenib) should be carefully monitored by their physicians for high blood pressure.

Hepatocellular carcinoma usually is a development of either a viral hepatitide infection (hepatitis B or C) or cirrhosis (usually because of alcoholism). HCC is the 5th most common tumor worldwide, affecting males significantly more than females.

Liver cancer makes more than 600,000 million victims worldwide each year and is currently treated with limited success using a mix of surgery, radiation and chemotherapy.

In February, Bayer Health Care Pharmaceutical and Onyx Pharmaceuticals Inc said they had stopped a phase III trial of Nexavar in patients with non-small cell lung cancer, because the product failed to help patients live longer than standard treatment.

Nevaxar is one of Bayer’s most promising new drugs. The company has previously said it expects it to generate combined annual sales of billions of dollars. Sorafenib, the main ingredient in Nexavar, belongs to a new class of cancer treatments known as kinase inhibitors, which deactivate the enzyme that trigger tumor cell growth or cell division. The drug is designed to subdue tumor growth rather than destroying existing cancer cells.



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