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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

e neutropenia (20%), and cardiac failure (3%).

"Although there are a number of treatment regimens that have been studied as salvage therapies in patients with relapsed aggressive NHL, few have demonstrated a high proportion of complete responses and many of the remissions achieved are of relatively short duration," said Jack W. Singer, M.D. Chief Medical Officer at CTI. "Patients who have completed a course of CHOP therapy are unable to be retreated with the same regimen due to the potential for severe heart toxicity when the lifetime limit of doxorubicin is exceeded.  Pixantrone has substantially less cardiotoxicity than doxorubicin in animal models and was found to be adequately tolerated in patients treated with prior doxorubicin in phase I trials.  The present study suggests that use of pixantrone with CPOP not only offers a high response rate, but in some patients these responses had impressive durability.  Four patients in the study had unmaintained remissions of between 4+ and 6+ years duration following CPOP, which is highly unusual in the setting of treating relapsed disease. The opportunity to re-challenge patients with a CHOP-like regimen, using pixantrone instead of doxorubicin after relapse from initial therapy with CHOP indicates that pixantrone-based regimens may represent a new approach to managing relapsed aggressive NHL. A Phase III clinical trial with pixantrone in this setting has recently been initiated, the PIX-R TRIAL™."

About Pixantrone and the CPOP Regimen

This trial examines the safety and potential efficacy of pixantrone (CPOP) when it is used in place of doxorubicin in the CHOP regimen for patients with relapsed aggressive NHL who had failed at least one prior treatment.  

Patients received up to six cycles of CPOP therapy. Cycles were every 21 days.  The phase I dose level was 80-180 mg/m for phase I, and the phase II recommended dose was 150 mg/m2. For both phases, dosing
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SOURCE Cell Therapeutics, Inc.
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Related medicine technology :

1. FDAs Office of New Drugs Meets With Cell Therapeutics on its Appeal on Pixantrone
2. Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkins Lymphoma
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
5. Inability of Pixantrone to Form Toxic Iron Complexes Results in Significant Reduction in Cardiac Cell Toxicity Compared to Currently Marketed Anthracyclines
6. 18 month Follow-up Data on Phase III Study of Pixantrone in Late Stage Relapsed or Refractory, Aggressive Non-Hodgkins Lymphoma Continues to Demonstrate Significant Improvement in Complete Remission and Progression Free Survival Over Standard Chemotherap
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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11. Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment
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