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"The data being presented at the EHA annual meeting continue to support the development of carfilzomib as a potential new treatment option for patients with multiple myeloma," said Michael Kauffman, M.D., Ph.D., Chief Medical Officer at Onyx. "Additionally, a European Phase 3 clinical trial, known as the FOCUS trial, will be underway shortly to compare the efficacy of single-agent carfilzomib to that of best supportive care in patients with relapsed/refractory multiple myeloma. This trial is intended to support a registrational filing with the European Medicines Agency."
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Carfilzomib data presentations:
Results of PX-171-004, an Ongoing Open-label, Phase II Study of Carfilzomib in Patients with Relapsed and/or Refractory Multiple Myeloma (R/R MM) with or without Prior Bortezomib Exposure
PX-171-006, a Phase Ib Dose-Escalation Study of Carfilzomib + Lenalidomide + Low-Dose Dexamethasone (CRd) in Relapsed and/or Refractory Multiple Myeloma
Carfilzomib, a Novel Proteasome Inhibitor, Exhibits Minimal Neurotoxic and Peripheral Neuropathic Effects in Preclinical and Clinical Studies
Phase II Study of Carfilzomib in Patients with Relapsed or Refractory Multiple Myeloma and Varying Degrees of Renal Insufficiency
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.
The pivotal Phase 2b monotherapy study, also known as 003-A1, enrolled patients with relapsed/refractory multiple myeloma. Top-line results, expected in mid-2010, may support the filing of a U.S. New Drug Application (NDA) by year-end 2010.
In addition, Onyx intends to initiate a large, randomized international Phase 3 clinical trial, known as 009 trial, 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 (EMA) on the design and planned analysis of the 009 trial. 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) According to estimates by the European Network of Cancer Registries, there are 21,420 new cases of multiple myeloma in Europe each year and around 15,000 deaths from this illness. It is estimated that 60,000 people in Europe are currently living with this disease.
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, a targeted alpha-folate inhibitor, and ONX 0912, an oral proteasome inhibitor, are 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
-- Dr. Keith Stewart, Mayo Clinic, U.S. -- Sunday, June 13, 2010, 9:00 - 9:15 hrs, Hall B -- 1099, Oral Presentation: Myeloma and Other Monoclonal Gammopathies - Clinical 2
SOURCE Onyx Pharmaceuticals, Inc.
