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Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma
Date:12/3/2010

decision not to approve an NDA, by raising the matter with the supervisor of the FDA office that made the decision. The formal dispute resolution process exists to encourage open, prompt discussion of scientific (including, medical) disputes and procedural (including, administrative) disputes that arise during the drug development, new drug review, and post-marketing oversight processes of the FDA.

Based on the guidance documents available from the FDA, CTI expects an FDA decision on the appeal in the first quarter of 2011.

CTI continues to prepare for the initiation of an additional pixantrone clinical study in the U.S. that would serve as either a post-approval confirmatory study or as a second registration study for approval in the U.S. This trial, referred to as PIX306, was submitted for a Special Protocol Assessment ("SPA") review by the FDA.

Also, CTI filed a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") for approval of pixantrone in Europe which was accepted for review on November 17, 2010.

About PixantronePixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines--rather than intercalation with DNA--pixantrone alkylates DNA--forming stable DNA adducts, with particular specificity for CpG rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone to prevent the binding of iron and perpetuation of superoxide production--both of which are the putative mechanism for anthracycline i
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SOURCE Cell Therapeutics, Inc.
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