SEATTLE, Nov. 18, 2010 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that CTI's Marketing Authorization Application ("MAA") seeking approval for Pixuvri™ (pixantrone dimaleate) for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") was validated and accepted for review by the European Medicines Agency ("EMA"). Validation indicates that the application is complete and that the EMA's review process has begun.
"We look forward to working with our rapporteurs and the EMA during their review process in an effort to bring pixantrone to patients for whom there are currently no available drugs in this setting," said James A. Bianco, M.D., CEO of CTI.
The EMA's review of the MAA will follow the centralized marketing authorization procedure and, if the MAA is approved, Pixuvri expects to receive marketing authorization in the E.U. member states.
The Company also plans, in 2011, to submit a marketing application in selected other countries beginning with Switzerland.
Pixantrone was initially granted orphan drug status by the EMA for the treatment of diffuse large B-cell lymphoma (DLBCL), but based on the expansion of the current MAA to the broader aggressive NHL population, CTI has agreed to withdraw the orphan designation from the E.U. register.
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. We believe that these structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, we believe 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 induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline like potency in the treatment of relapsed/refractory aggressive lymphoma without unacceptable rates of cardiotoxicity.
About Cell Therapeutics, Inc.Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com/.
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This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective and/or less toxic and effective for the treatment of relapsed or refractory, aggressive NHL and/or other tumors as determined by the EMA, that the EMA may not approve CTI's MAA after review, that Pixuvri may not prove effective as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL, that CTI may not submit a marketing application in selected other countries in 2011, and CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise. Media Contact:Dan Eramian T: 206.272.4343C: 206.854.1200E: email@example.com.CellTherapeutics.com/press_roomInvestors Contact:Ed BellT: 206.282.7100Lindsey Jesch LoganT: 206.272.4347F: 206.272.4434E: firstname.lastname@example.org.CellTherapeutics.com/investorsMedical Information Contact:T: 800.715.0944E: email@example.com
|SOURCE Cell Therapeutics, Inc.|
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