Cell Therapeutics Inc., (CTI) a biopharmaceutical company, announced that, following discussions with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), the CHMP may issue an opinion on CTI's Marketing Authorization Application (MAA) for Pixuvri (Pixantrone) in mid-February.

In the interim, CTI will continue to work with the CHMP on the Summary of Product Characteristics and other labelling items for Pixuvri (Pixantrone). CTI is seeking an authorization to market Pixuvri (Pixantrone) in the EU for the treatment of adult patients with multiple relapsed or refractory aggressive non-Hodgkin's B cell lymphomas (NHL). If approved by the EMA, Pixuvri (Pixantrone) would address an unmet medical need, as there are no approved therapies for these patients.

In the US FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of April 24, 2012 for a decision on the New Drug Application for Pixuvri (Pixantrone) in the same indication.

Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumour 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 in an effort to prevent the binding of iron and perpetuation of superoxide production -- both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline-like potency in the treatment of relapsed/refractory B cell NHL without unacceptable rates of cardio toxicity.

CTI is committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.