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Onyx Provides Update of Development Programs; Meets Key Manufacturing Milestone Thursday November 14, 4:02 pm ET RICHMOND, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals Inc. (Nasdaq: ONXX - News) today announced that BAY 43-9006, a novel anticancer investigational agent, is moving toward potential Phase III clinical trials in 2003. BAY 43-9006 is an orally active small molecule raf kinase inhibitor being developed in collaboration with Bayer Corporation. Onyx also reported that the U.S. Food and Drug Administration (FDA) has approved an amendment Onyx filed to the Chemistry, Manufacturing and Controls (CMC) section of its Investigational New Drug (IND) application for ONYX-015, allowing the company to use product manufactured at XOMA (US) LLC at a larger scale. At the same time, the company reiterated that it is actively seeking a partner for its therapeutic virus program -- including the lead product candidate in this program, ONYX-015 -- in order to reduce its burn rate. ADVERTISEMENT Clinical Progress of BAY 43-9006 "Bayer and Onyx plan to begin Phase III clinical studies of BAY 43-9006 during 2003, after the Phase III strategy is finalized and plans are reviewed with and approved by relevant health authorities," said Hollings C. Renton, Onyx chairman and chief executive officer. Preliminary Phase I clinical data for BAY 43-9006 were reported at the 2002 annual meeting of the American Society of Clinical Oncology (ASCO) and will be updated in Frankfurt, Germany at EORTC-NCI-AACR 2002 (European Organization for Research and Treatment of Cancer -- National Cancer Institute -- American Association for Cancer Research 2002 meeting) on November 20. These encouraging early data supported the initiation of the first Phase II efficacy study of BAY 43-9006 as a single agent during the third quarter, triggering a $5 million milestone-based loan payment to Onyx. Multiple Phase I clinical trials of this novel agent in combination with a range of chemotherapeutics are also ongoing. Data from these studies will be presented at upcoming scientific meetings, and will be used to guide decisions to advance BAY 43-9006 toward approval. Upon the commencement of Phase III studies, Onyx will receive $15 million in loan funding from Bayer. BAY 43-9006 is an inhibitor of the enzyme raf kinase, a critical component of the ras pathway -- a cascade of chemical signals that control cell division. 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 lung cancer, according to the American Cancer Society. Development Update on ONYX-015 The clinical progress of ONYX-015 has been limited to date by the supply of material. Working with XOMA, Onyx has been able to scale up the manufacturing process by tenfold. The FDA`s approval of the CMC amendment allows the use of material made at this larger scale and significantly reduces the supply constraints for clinical development. Onyx is taking steps to position its therapeutic virus program for new partnering opportunities. In September, Onyx cleared the path to re-partner this program when it reacquired all rights to ONYX-015 and an Armed Therapeutic Virus(TM) product from Warner-Lambert Company, a subsidiary of Pfizer, Inc. Onyx is conducting a Phase II trial of ONYX-015 in refractory head and neck cancer. Early results from this trial may be useful in the ongoing dialog with the FDA about potential registration in head and neck cancer. Although a Phase III trial remains open in recurrent head and neck cancer, the company is not actively recruiting patients until agreement is reached with the FDA regarding the registration path. Onyx is planning a clinical trial of ONYX-015 in metastatic colorectal cancer to establish a safe dose in combination with standard chemotherapeutic regimens. Data from an earlier Onyx Phase I/II study showed early signs of activity in this indication. Patients receiving the highest dose experienced extended survival compared with patients receiving lower doses. Signs of tumor shrinkage were observed in a few patients that had failed several regimens of chemotherapy. There are more than 150,000 newly diagnosed patients with colorectal cancer annually in the U.S., and approximately 30 percent of those patients will develop metastatic disease. "We are actively seeking a partner for our therapeutic virus program to reduce our burn rate," said Mr. Renton. "With this approved new supply source for ONYX-015, an additional registration path in metastatic colorectal cancer, and follow-on candidates, we believe we have an attractive package to offer a partner." Webcast of Conference Call Onyx announced that it will webcast a conference call today, November 14, 2002, at 4:45 p.m. EST to discuss the third quarter financial results and current development activities. Hollings C. Renton, chairman and chief executive officer will host the call. To access the webcast, log on to www.onyx-pharm.com, click on the "Investor Relations" tab, and click on "Webcast -- November 14, 2002." The webcast may also be accessed directly through PR Newswire/First Call by going to http://www.firstcallevents.com/service/ajwz369995019gf12.htm… . Please log on 15 minutes in advance of the call to determine software requirements for accessing the webcast. A replay of the webcast will be available through both the Onyx and the PRNewswire/First Call websites two hours after the completion of the call through November 28, 2002. New Website Launched Onyx also announced that it will relaunch its website, www.onyx-pharm.com, on Friday, November 15, 2002. The site has been redesigned to provide investors, patients and the medical community with an updated and comprehensive view of the company, its clinical candidates and product development programs. About Onyx 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, BAY 43-9006 and ONYX-015. For more information about Onyx`s pipeline and activities, visit the company`s newly updated website at www.onyx-pharm.com. This press release contains 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 our 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 (14.11.02 22:09:09) |
| Beitrag: | 60 von 229 (ID:7852662) |
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