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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

of the other agents in the CHOP regimen was standard; cyclophosphamide at 750 mg/m2 IV, vincristine at 1.4 mg/m2 IV on day one, and prednisone or prednisolone 100 mg orally on days one through five.

PIX-R TRIAL™ Design

The PIX-R trial is designed to be a randomized, multicenter study comparing pixantrone plus rituximab to gemcitabine plus rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma ("DLBCL") or DLBCL transformed from follicular lymphoma who have received one to three prior lines of therapy, including CHOP-R or an equivalent regimen. The patients to be enrolled in the PIX-R trial cannot be eligible for high-dose (myeloablative) chemotherapy and stem cell transplant, but patients who relapse after such a procedure are eligible. The co-primary endpoints for the PIX-R trial are progression free survival and OS with secondary endpoints including ORR (ORR equals complete responses plus partial responses), complete response rate and safety.  CTI is targeting to enroll 350 patients over 18 months in the PIX-R trial.

The PIX-R trial may serve as either a post-marketing commitment trial or as a follow-on pivotal trial depending on the outcome of a formal appeal that CTI submitted to the U.S. Food & Drug Administration's (the "FDA") Office of New Drugs in the FDA's Center for Drug Evaluation and Research in December 2010 regarding its 2010 decision about CTI's new drug application (the "NDA") for pixantrone. The NDA for pixantrone was based on the results of the PIX 301 trial, a randomized trial comparing pixantrone as monotherapy to a choice of standard single-agent chemotherapy in relapsed/refractory aggressive NHLpatients. CTI expects a decision regarding its appeal in the second quarter of 2011.

EMA

In Europe, the Marketing Authorization Application (the "MAA") for pixantrone as monotherapy for patients with relapsed or refractory aggressive NHL is currently under review b
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SOURCE Cell Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

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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
10. Pixantrone in Combination with Chemotherapy Regimens Produces Overall Response Rates of 58-74% with Complete Remission Rates of 37-57% in Relapsed/Refractory Aggressive or Indolent NHL
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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