NEW ORLEANS, Dec. 6 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. today announced updated safety data from the pivotal Phase 2b 003-A1 study, known as the 003 trial, demonstrating that carfilzomib is well-tolerated in heavily pre-treated relapsed and refractory multiple myeloma patients. These data were presented today at the ASH/ASCO Joint Symposium at the 51st annual meeting of the American Society of Hematology (ASH) in New Orleans. Enrollment in this trial is complete (n=269), and full results, expected in 2010, could support a potential new drug application (NDA) filing by year-end 2010.
Dr. Jagannath also presented results from the Phase 2 003-A0 study, which recruited patients whose myeloma had relapsed from two or more prior therapies and was refractory to their previous therapy. This study is the lead-in study for the current Phase 2b registrational trial in the same population. Data from this study was initially presented at the American Society for Clinical Oncology (ASCO) annual meeting in June 2009. Patients in the study had a median of five prior therapies. Previously presented efficacy data from 39 evaluable patients in the 003-A0 pilot study included an 18 percent overall response rate (partial response or better) and a 26 percent clinical benefit rate (minor response or better), median time to tumor progression of 5.1 months and a median of 7.4 months response duration.
Dr. Jagannath presented new safety data on 141 patients in the 003-A1 trial, showing that carfilzomib was well tolerated at the 27 mg/m(2) dose. Grade 3/4 hematologic events included anemia (13.5 percent), thrombocytopenia (16.3 percent), neutropenia (3.5 percent), and febrile neutropenia (0.7 percent). The rate of grade 3/4 peripheral neuropathy was 0.7 percent. The regimen was well tolerated with prolonged administration of more than 12 cycles (48 weeks) in approximately 10% of patients, and no clinically significant cumulative toxicities have been noted to date. Both portions of the trial are being conducted in collaboration with the Multiple Myeloma Research Consortium.
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About Carfilzomib
Carfilzomib is a selective, next generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma. Carfilzomib is currently undergoing evaluation as a single agent in multiple Phase 2 and Phase 1 clinical trials in relapsed or refractory multiple myeloma. These trials include a Phase 2b monotherapy study in patients with relapsed, refractory multiple myeloma, the pivotal trial that could support a new drug application (NDA) filing by the end of 2010. Carfilzomib is also being evaluated in advanced solid tumors.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar((R) )(sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a next-generation proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, a targeted alpha-folate inhibitor, is currently in Phase 1 testing. For more information about Onyx, visit the company's website at www.onyx-pharm.com.
Forward Looking Statements
This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the anticipated benefits of the acquisition of Proteolix and the timing, progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of carfilzomib. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including the risk that Proteolix's operations will not be integrated successfully into Onyx's, the risk that Onyx may not realize the anticipated benefits of the acquisition and risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2008, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
Onyx Pharmaceuticals, Inc.
