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Final OPAL Phase II Results of Tosedostat Demonstrate Significant Response Rates in Elderly Patients with Treatment Refractory or Relapsed Primary or Secondary Acute Myeloid Leukemia (AML)
Date:12/13/2011

SAN DIEGO, Dec. 13, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ: CTIC and MTA: CTIC) and Chroma Therapeutics Ltd. announced that final results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) were presented by Jorge Cortes, M.D. of the University of Texas M.D. Anderson Cancer Center during the Acute Myeloid Leukemia - Therapy, excluding Transplantation: Clinical Studies session at the American Society of Hematology Annual Meeting.  Tosedostat is a novel, orally administered amino acid deprivation response (AADR) inducer, which targets and deprives sensitive tumor cells of the amino acid building blocks they need to make proteins necessary for tumor cell survival.

 

Highlights of the study:

 

  •  Elderly (median age 72 years) poor risk patient group,  approximately half (52%) of whom had AML refractory to their last treatment prior to starting tosedostat
  • Fifty-one  percent (51%) of patients experienced disease control with 22% achieving a major leukemic response: 12% of patients achieved a complete (CR) bone marrow responses
  • While responses were observed across all types of prior AML therapy, 36% of patients who had failed treatment with hypo-methylating agents (HMAs) achieved a response, similarly 37% of patients with secondary AML from prior myelodysplastic syndrome (MDS) achieved a response, suggesting this population is potentially highly sensitive to tosedostat anti-leukemic activity
  • Median overall survival for patients achieving a CR was 323 days, Partial Response (PR) 195 days, Stable Disease (SD) 162 days
  •  Tosedostat was well tolerated with most frequent grade >3 side effect being diarrhea (4%), fatigue (21%), and febrile neutropenia (29%)
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SOURCE Cell Therapeutics, Inc.
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