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Tosedostat OPAL Study in Acute Myeloid Leukemia Published in Lancet Oncology
Date:3/4/2013

  • Overall response rate (ORR) of 22% (16/73), with 10% (7/73) achieving a complete response (CR) and 29% (21/73) of patients achieving stable disease (SD) for a disease control rate of 51%.
  • High response rates were observed in patients who previously received HMAs or initially were diagnosed with MDS, with an ORR of 38% (10/26) and 37% (7/19), respectively.
  • Median overall survival (OS) for patients achieving a CR was 322 days; partial response (PR) 195 days; and SD 162 days.
  • Adverse events were similar between dosing groups. Tosedostat was generally well-tolerated, with the majority of adverse events of grade 1 and 2. The most common treatment-related serious adverse event was febrile neutropenia reported in 29% of patients. 

"There are limited therapeutic options available for elderly patients who, after failing hypomethylating therapy, experience AML progression from MDS," said Dr. Cortes. "The novel mechanism of action and observed response rate in this completed Phase 2 study suggests that tosedostat could address this unmet medical need. We are currently conducting a Phase 2 study investigating the combination of tosedostat with azacytidine - an HMA, or low-dose cytarabine, a standard leukemia therapy in patients with relapsed or refractory AML and MDS - to determine if tosedostat would be safe and more effective when used in combination with these agents." 

The publication by Dr. Cortes, et al. titled "Two dosing regimens of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (OPAL): a randomized open-label phase 2 study," is available at http://www.thelancet.com/journals/lanonc/issue/current.

About Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

About 13,780 new cases of AML were expected to be diagnosed in the Un
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SOURCE Cell Therapeutics, Inc.
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