EMERYVILLE, Calif., May 20 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the presentationof several studies evaluating carfilzomib, a selective, next-generation proteasome inhibitor, at the 46th American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8, 2010 in Chicago,
"We are further encouraged by the growing body of evidence that supports carfilzomib's potential as a new treatment option for patients with multiple myeloma," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development at Onyx. "We look forward to sharing final data from our Phase 2b 003-A1 pivotal trial that we anticipate will form the basis of an initial New Drug Application (NDA) filing for carfilzomib by year end."
Carfilzomib data presentations:
Results of an Ongoing Open-Label, Phase 2 Study of Carfilzomib in Patients with Relapsed and/or Refractory Multiple Myeloma (MM)
Dose Escalation Study of Carfilzomib Plus Lenalidomide and Low Dose Dexamethasone (CRd) in Relapsed and Refractory Multiple Myeloma (MM)
Phase 2 Study of Carfilzomib in Patients with Relapsed or Refractory Multiple Myeloma and Renal Insufficiency (MM)
Neurotoxic and Peripheral Neuropathic Effects in Preclinical and Clinical Studies of Carfilzomib, a Novel Proteasome Inhibitor (PI)
Solid Tumors & Multiple Myeloma
Updated Results of a Phase 1b/2 Study of Carfilzomib in Patients with Relapsed Malignancies
About the Carfilzomib Development Program
Carfilzomib is a selective, next generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma.
In addition, the company intends to initiate a large, randomized international Phase 3 clinical trial, known as the 009 trial, this year to study the combination of lenalidomide and low dose dexamethasone with or without carfilzomib in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMEA) on the design and planned analysis of the 009 trial. A second Phase 3 clinical trial, the 011 trial, of carfilzomib in relapsed and refractory myeloma is planned in Europe. Carfilzomib is also being evaluated in advanced solid tumors.
About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with MM and approximately 20,000 new cases are diagnosed annually.(i) Worldwide, more than 180,000 people are living with MM and approximately 86,000 new cases are diagnosed annually.(ii)
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 NexavarŽ (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 is a targeted alpha-folate inhibitor currently in Phase 1 testing. For more information about Onyx, visit the company's website at www.onyx-pharm.com.
NexavarŽ (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals.
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 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 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, 2009, 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.
(i)National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
(ii)International Agency for Research on Cancer, GLOBOCAN 2002 database
SOURCE Onyx Pharmaceuticals, Inc.
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