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Onyx Pharmaceuticals (ticker: ONXX, exchange: NASDAQ) News Release - 4/9/2002 -------------------------------------------------------------------------------- BAY 43-9006 Data Presented at 2002 AACR Meeting RICHMOND, Calif., Apr 9, 2002 /PRNewswire-FirstCall via COMTEX/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that data supporting the mechanism of action of BAY 43-9006, a small molecule Raf kinase inhibitor, were presented at the annual American Association for Cancer Research Conference in San Francisco, California. BAY 43-9006 was identified as part of a joint research effort between Bayer Corporation and Onyx and is being codeveloped by the companies. BAY 43-9006 is a novel compound directed toward a specific molecular target misregulated in cancer. Data suggests 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 may 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 40 percent of lung cancers. In preclinical studies in vitro, BAY 43-9006 has demonstrated inhibition of Raf-dependent cellular proliferation. In vivo, BAY 43-9006 inhibited tumor growth in several human tumor xenografts. Phase I clinical trials for BAY 43-9006 started in 2000. To date, data have been presented showing results from several single-agent studies. The data presented today provide biochemical evidence that BAY 43-9006 inhibits the Raf kinase pathway, supporting the mechanistic approach. Evidence of Raf kinase inhibition can be measured by suppression of the level of ERK phosphorylation. The data presented today demonstrated inhibition of ERK phosphorylation in a study of 66 patients treated with BAY 43-9006. Specifically, biomarker studies were conducted with peripheral blood lymphocytes (PBLs) collected from patients with advanced cancers treated with BAY 43-9006 at various dose levels as part of a Phase I clinical trial. PBLs were monitored for BAY 43-9006-dependent inhibition of ERK phosphorylation. Blood samples were collected for analysis before treatment with BAY 43-9006 and on days 1, 2 and 10-21 post treatment to allow comparisons among patients at different dose levels. Investigators reported statistically significant inhibition of stimulated ERK phosphorylation in three out of six patients following continuous treatment with 400 mg bid for 21 days, and in 4 out of 6 patients following continuous treatment with 800 mg bid for 14 days. The time course and extent of ERK inhibition in PBLs was related to the dose level of BAY 43-9006 administered. Additional data describing the chemistry program leading up to BAY 43-9006 was presented. The investigators presented the optimization process and the molecular structure and activity relationship that led to the novel structure of BAY 43-9006. "These data provide additional support for the rationale for BAY 43-9006 development. We are extremely encouraged with the biomarker data reported at this meeting. We believe that these data support the mechanism of action of BAY 43-9006 in inhibiting the Raf kinase in the Ras pathway, thereby suppressing the ERK phosphorylation levels. In addition, the data suggest that the dose levels achieved in the Phase I clinical trials are capable of inhibiting the mechanistic target," said Hollings C. Renton, Chairman of the Board and Chief Executive Officer of Onyx. "This important meeting provide us with an opportunity to emphasize BAY 43-9006, Onyx`s second product in clinical development. Onyx and Bayer anticipate the completion of four Phase I studies shortly. In addition, we have an ongoing Phase I/II study in patients with acute myelogenous leukemia and patients with myelodysplastic syndrome. We have recently initiated a Phase I/II study of BAY 43-9006 in combination with a chemotherapy agent. We are currently planning to initiate additional Phase I/II studies of the agent in other chemotherapy combination regimens and Phase II studies of BAY 43-9006 as a single agent in various tumor types." 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 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 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 the product and Onyx gets a royalty. Onyx Pharmaceuticals is engaged in the discovery and development of novel cancer therapies. Based on its proprietary technologies that target the molecular basis of cancer, the company is developing two lead products, ONYX-015 and BAY 43-9006. For more information about Onyx`s pipeline and activities, visit the company`s web site 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, 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 |
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| aus der Diskussion: | onyx pharmaceut. im juhu musterdepot! |
| Autor (Datum des Eintrages): | Bocknase (10.04.02 09:30:32) |
| Beitrag: | 48 von 229 (ID:6066646) |
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