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Onyx Updates Phase I Data for BAY 43-9006 at 2002 EORTC-NCI-AACR Meeting in Frankfurt Wednesday November 20, 6:00 am ET RICHMOND, Calif., Nov. 20 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced updated Phase I clinical data for BAY 43-9006, a novel anticancer investigational agent. BAY 43-9006 is an orally active small molecule raf kinase inhibitor being co-developed in a collaboration between Onyx and Bayer. The updated data were presented today in Frankfurt, Germany, at the European Organisation for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI) and American Association for Cancer Research (AACR) 2002 meeting. ADVERTISEMENT Safety and preliminary signs of antitumor activity were presented in posters from three of four clinical sites, including: the West German Cancer Center at the University of Essen, the Jules Bordet Institute in Belgium, and the Hamilton Regional Cancer Centre and Princess Margaret Hospital in Canada. An additional summary table included patients from a Phase I trial at the Dana Farber Cancer Institute and the University of Southern California in the United States. To date, a total of 27 of 114 patients treated at higher doses remain on BAY 43-9006 with disease that had not progressed after more than six months, and seven patients have been treated with BAY 43-9006 for more than one year, also with no disease progression. Of these, a patient with a previously reported partial response with hepatocellular carcinoma has remained on BAY 43-9006 therapy without progression over nine months, and a second patient with a partial response with renal cell carcinoma was on study for 44 weeks before progressing. In these trials, BAY 43-9006 was administered orally at various schedules at doses up to 800 mg twice daily, as a single agent, to patients with advanced cancers, including colorectal, liver, breast, ovarian, and other cancers whose disease had been previously treated with at least one chemotherapeutic agent. The updated results support the previously reported safety data for BAY 43-9006 in patients with advanced malignancies. Toxicities described in the clinical data presented were generally described as mild-to-moderate by the clinical investigators. The most common dose-limiting side effects were diarrhea and reversible skin toxicity. There was no myelosuppression seen to date. Based on these studies, a Phase II dose was determined to be 400 mg twice a day continuous treatment. Data reported from the Belgium poster reports a subset of five patients with renal cell carcinoma treated for an average of more than 23 weeks, in which one had a partial response and four demonstrated stable disease. In addition, three patients including the partial response, experienced tumor shrinkage of greater than 20 percent. "Our early data in a small sample of ovarian cancer patients showed that three of five patients treated with BAY 43-9006 achieved stable disease, and two of these patients continue to be treated after one year," stated Dr. Hal Hirte of the Hamilton Regional Cancer Center in Canada. "These Phase I clinical data provide additional support pointing to the potential tolerability of this raf kinase inhibitor, which is important information as we plan our Phase III program," said Leonard E. Post, Ph.D., Onyx senior vice president, research and development. About BAY 43-9006 BAY 43-9006 is a novel investigational compound directed against a specific molecular target misregulated in cancer. Data suggest BAY 43-9006 may selectively block signal transduction in the ras pathway by inhibiting a specific enzyme known as raf kinase. It is the first orally active compound in this class to undergo clinical testing. Abnormal activation of the ras pathway is believed to play an integral role in the genesis of many cancers, and blocking this pathway may inhibit tumor growth. Mutations in the ras gene occur in approximately 30 percent of all human cancers, including 80 percent of pancreatic cancer, 50 percent of colon cancer and 30 percent of non-small cell cancer, according to the American Cancer Society. The co-development collaboration between Onyx and 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 else in the world except Japan, Onyx`s share is somewhat less than 50 percent since Bayer has exclusive marketing rights. In Japan, Bayer funds product development, and Onyx receives 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. This press release may contain certain 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 the matters described in this press release, the timeline for clinical activity, results of pending or future clinical trials, dependency on third parties to manufacture its products, 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 filed with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K, may affect the actual results achieved by the company. Make Your Opinion Count - Click Here -------------------------------------------------------------------------------- Source: Onyx Pharmaceuticals, Inc. |
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| aus der Diskussion: | onyx pharmaceut. im juhu musterdepot! |
| Autor (Datum des Eintrages): | panik (20.11.02 12:06:22) |
| Beitrag: | 61 von 229 (ID:7894464) |
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