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

otherapy and stem cell transplant, but patients who relapse after such a procedure are eligible. The co-primary endpoints for the PIX-R trial are PFS and OS with secondary endpoints including overall response rate (ORR equals complete responses plus partial responses), complete response rate and safety. To date, over 100 large U.S.-integrated oncology sites have signed up to participate in the PIX-R trial and 40 of such sites are preparing to initiate enrollment when the trial begins, which may be as early as later this month.   CTI is targeting to enroll 350 patients over 18 months in the PIX-R trial. CTI plans to perform the primary analysis of PFS first, which, depending on the outcome of CTI's appeal with the OND, could serve as the basis for resubmission of the NDA for pixantrone under accelerated approval regulations. Co-primary endpoints allow the analysis and reporting of PFS without a statistical penalty while the trial data matures and before OS is analyzed.  OS, as the co-primary endpoint, will be analyzed at the end of the trial.

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 and forms 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 ind
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SOURCE Cell Therapeutics, Inc.
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