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Substitution of Pixantrone for Doxorubicin in CHOP Chemotherapy Regimen Produces High Rates of Complete Remissions and Long-Term Disease Free Survival in Patients with Relapsed/Refractory Aggressive NHL Who Previously Failed Frontline CHOP Therapy
Date:4/3/2011

SEATTLE, April 4, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that the April 2011 edition of the peer reviewed journal, Leukemia & Lymphoma (April 2011; 52(4): 620–628) published results of a phase I/II clinical trial evaluating the effect of cyclophosphamide, pixantrone, vincristine, and prednisone ("CPOP") in treating patients with aggressive non-Hodgkin's lymphoma ("NHL") who relapsed following initial therapy with cyclophosphamide, doxorubicin, vincristine (Oncovin), and prednisone ("CHOP").  In the CPOP regimen, pixantrone substitutes for doxorubicin (H) in the CHOP regimen.  Peter Borchmann, M.D., of the University Hospital of Cologne, led the study.  CPOP produced high rates of complete remissions ("CR") and overall response rate ("ORR").  In some patients, these remissions were highly durable despite patients having relapsed after receiving CHOP and other multi-agent therapies.  

The study enrolled 35 patients in the phase I portion of the trial and 30 patients in the phase II portion of the trial. A major tumor response was reported for 80% and 73% of patients in phase I and II respectively, with 57% and 47% of the patients achieving a complete or unconfirmed CR. Median overall survival in the phase II portion of the trial was 17.9 months with four patients achieving notable long-term disease-free survival ranging from 55 to 77 months, despite in some cases having failed multiple prior regimens including stem cell transplantation. High response rates were also observed in the 43% of patients who had received prior rituximab as part of their front-line regimen (CHOP-R), with an ORR rate of 77% and CR rate of 54%. Myelosuppression was the most common toxicity. Side effects (grade 3/4) in phase I of the trial included febrile neutropenia (11%), grade 3/4 infections (3%), and cardiac failure (6%). In phase II of the trial, side effects (grade 3/4) included febril
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3. European Medicines Agency Grants Cell Therapeutics Orphan Drug Designation for Pixantrone in Diffuse Large B-Cell Lymphoma (DLBCL)
4. Cell Therapeutics Announces FDAs Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkins Lymphoma, February 10, 2010
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7. FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA
8. Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th
9. Overview of Pixantrone Phase III Clinical Data Presentation at American Society of Clinical Oncology 2009 Annual Meeting Now Available at Clinical Care Options
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