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Pancreas Cancer News and Archives | |
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Onyx and Bayer Initiate Phase
II Studies of Raf Kinase Inhibitor Richmond, California, September 4, 2002
The preliminary findings of four Phase I studies -- in Canada, the U.S., Belgium and Germany -- provided rationale for undertaking the Phase II study. Preliminary data from Phase I studies were reported at both the American Association for Cancer Research and the American Society of Clinical Oncology meetings earlier this year. Those data were used to determine the safety profile of the small molecule compound. Also presented were data that included two patients with confirmed partial responses; preliminary evidence of tumor shrinkage in five additional patients; and, in a subset of patients treated at higher doses, 45 patients who had disease stabilization. "Since this molecule targets the Ras pathway -- a pathway that data suggest plays a role in cell proliferation -- we are looking forward to the commencement of Phase II studies," commented Chairman and Chief Executive Officer of Onyx, Hollings C. Renton. In addition to exploring the utility of BAY 43-9006 alone in the hepatocellular Phase II trial, Bayer and Onyx have planned clinical trials in combination with a range of standard chemotherapeutics. Initially, these studies aim to identify regimens of the combined therapy that are sufficiently well tolerated. That would set the stage for follow-up Phase II and III studies to demonstrate the safety and efficacy profiles of the therapy. BAY 43-9006, an orally active small molecule Raf kinase inhibitor, was discovered and is being co-developed in a collaboration between Onyx and Bayer. Data suggest that BAY 43-9006 selectively blocks signal transduction in the Ras pathway by inhibiting a specific enzyme known as Raf kinase, and is the first orally active compound in this class to undergo clinical testing. The Ras signaling pathway is believed to play an integral role in the genesis of many cancers, and blocking this pathway has been shown to inhibit tumor growth in vivo. Mutations in the Ras gene occur in approximately 30 percent of all human cancers, including 90 percent of pancreatic cancer and 50 percent of colon cancer. The co-development collaboration with Bayer results in Onyx funding 50 percent of the development costs for BAY 43-9006. In return, Onyx has a 50/50 profit share in the United States where the companies can co-promote the product. Everywhere in the world except Japan, Onyx's share is somewhat less than 50 percent since Bayer has exclusive marketing rights. In Japan, Bayer funds the product, and Onyx gets a royalty. About Onyx Pharmaceuticals Onyx Pharmaceuticals is engaged in the discovery and development of novel cancer therapies and has proprietary technologies that target the molecular basis of cancer. The company is developing two lead products: BAY 43-9006 in conjunction with Bayer, and ONYX-015. For more information about Onyx's pipeline and activities, visit the company's website at www.onyx-pharm.com. About Bayer Corporation Best known for its flagship product, Bayer Aspirin, Bayer Corporation produces a broad range of healthcare, crop protection, polymer and chemical products that help diagnose and treat diseases, purify water, preserve local landmarks, protect crops, advance automobile safety and durability and improve people's lives. Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion in 2001 and is one of Fortune magazine's Most Admired Companies. The company employs 21,500 people. It is a member of the worldwide Bayer Group, a $27 billion international healthcare and chemicals group based in Leverkusen, Germany. The Bayer Group stock is a component of the DAX and is listed on the New York Stock Exchange.
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