Jul 22 2010
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the company has begun enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone 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 ASPIRE trial.
"We have seen encouraging interim results from previous studies of carfilzomib in combination with lenalidomide and dexamethasone, and this Phase 3 trial will further evaluate this promising three-drug combination therapy in patients with relapsed myeloma," said Michael Kauffman, M.D., Ph.D., Chief Medical Officer at Onyx. "In addition to this Phase 3 study, we look forward to reporting the top-line results from our pivotal Phase 2b single-agent trial in advanced myeloma patients shortly, which may enable us to pursue an accelerated approval strategy in the United States. Given the promising efficacy signal observed to date for carfilzomib and the potential to combine it with other agents, we believe that carfilzomib may have the opportunity to benefit a broad range of myeloma patients, and we are committed to advancing this compound as quickly as possible."
SOURCE Onyx Pharmaceuticals, Inc.
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