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Onyx and Bayer Report Progress With Novel Oral Raf Kinase Inhibitor (BAY 43-9006) for Treatment of Cancer at ASCO Meeting BAY 43-9006 First Orally Active Compound in Class to Undergo Clinical Testing SAN FRANCISCO, Calif., May 14 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - news) and its development partner Bayer Corporation announced that Phase I clinical trial results for their novel oral Raf kinase inhibitor, known as BAY 43-9006, were presented today at the 37th Annual Meeting of the American Society of Clinical Oncology (ASCO) in San Francisco, California. The study was designed to determine the compound`s maximum-tolerated dose, toxicity profile, and pharmacokinetic properties when given orally to patients with refractory solid tumors. The presentation reported treatment of 30 patients with single and multiple doses of BAY 43-9006. Toxicities have generally been mild to moderate. Serum levels of BAY 43-9006 observed in preclinical models, which demonstrated antitumor activity, have been achieved in the Phase I dose escalating clinical trial, but dose escalation in this study continues since the companies believe a maximum tolerated dose has not yet been reached. ``We are encouraged by these preliminary data reporting that BAY 43-9006 is well tolerated and has good pharmacokinetic properties,`` said Dirk Strumberg, M.D., West German Cancer Center, who presented the data at the ASCO meeting. ``We look forward to moving ahead with further clinical development of this promising compound to see if it can prevent the progression of a wide variety of cancers.`` Phase I studies in Germany, United States, Canada and Belgium are ongoing. The companies anticipate that they will complete the Phase I studies later this year and, depending on final results of this study, will then initiate Phase II studies. BAY 43-9006 is a member of the emerging class of therapeutics called selective signal transduction inhibitors of the Ras pathway, and it is the first orally active compound in this class to undergo clinical testing. BAY 43-9006 is a selective agent designed to block the Ras signaling pathway in cells by inhibiting a specific enzyme known as Raf kinase. The Ras signaling pathway is believed to play an integral role in the growth of certain cancer tumors, and blocking this pathway could inhibit tumor growth. Mutations in the Ras gene occur in approximately 30 percent of all human cancers, including 90 percent of pancreatic cancer, 50 percent of colon cancer and some lung cancers. Onyx has collaborated with Bayer since 1994 to discover, develop and commercialize anticancer compounds that inhibit the function or modulate the activity of the Ras pathway. The agreement provides for sharing clinical development costs and resulting profits worldwide except for Japan. Onyx Pharmaceuticals is engaged in the discovery and development of novel cancer therapies. Based on its proprietary virus technologies, the company is developing its lead product, CI-1042 (ONYX-015). CI-1042 is currently in a Phase III clinical trial for head and neck cancer and in Phase I and II clinical trials for a number of different additional cancer indications. For more information about CI-1042 and Onyx`s pipeline and activities, visit Onyx`s web site at www.onyx-pharm.com. Bayer Pharmaceuticals is addressing the unmet medical needs of people with cancer by discovering and developing novel therapeutic approaches to the disease. Bayer has initiated clinical studies in four new anticancer therapies. Already a leader in developing diagnostic techniques for identifying cancers: Bayer is investing $1 billion annually in life-science research. This press release contains forward-looking statements regarding the development of potential human therapeutic products that involve a number of risks and uncertainties. Actual events may differ from the company`s expectations. In addition to matters described in this press release, the timeline for clinical activity, results of pending or future clinical trials and changes in the status of the company`s collaborative relationships, as well as the risk factors listed from time to time in the company`s periodic reports with the Securities and Exchange Commission, including but not limited to its Annual Report in Form 10-K, may affect the actual results achieved by the company. MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X18729069 SOURCE: Onyx Pharmaceuticals, Inc. |
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| aus der Diskussion: | onyx pharmaceut. im juhu musterdepot! |
| Autor (Datum des Eintrages): | panik (14.05.01 12:37:23) |
| Beitrag: | 27 von 229 (ID:3512503) |
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