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FDA Provides Guidance for Design of Cell Therapeutics' Pixantrone Pivotal Trial
Date:3/9/2011

ergy exists between pixantrone and rituximab when they are used in combination. We believe that pixantrone administered as a single agent had a significant effect on prolonging PFS with an accompanying trend in OS in the PIX 301 trial. Given these results and the similar patient population in the PIX-R trial, including the choice of comparator regimen, we believe this trial has the potential to establish the clinical benefit of pixantrone in this patient group to fulfill an important unmet medical need," added Dr. Bianco.

In December 2010, CTI submitted a formal appeal to the FDA's Office of New Drugs ("OND") in the FDA's Center for Drug Evaluation and Research 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 non-Hodgkin's lymphoma ("NHL") patients. CTI recently met with the OND to discuss the appeal. The OND requested, and CTI plans to supply the FDA with, additional analyses from the PIX 301 trial. CTI expects a decision regarding its appeal early in the second quarter of 2011.

In Europe, the Marketing Authorization Application (the "MAA") for pixantrone as monotherapy for patients with relapsed or refractory aggressive NHL is currently under review by the European Medicines Agency (the "EMA") based on the pixantrone (PIX 301) phase III study results.  

PIX-R TRIAL DesignThe 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 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) chem
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SOURCE Cell Therapeutics, Inc.
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