Cell Therapeutics, Inc. Expects That the European Medicines Evaluation Agency Committee for Medicinal Products for Human Use (CHMP) May Issue an Opinion on the Marketing Authorization Application ("MAA") on Pixuvri(TM) in Mid-February
Published: Jan 20, 2012
SEATTLE, Jan. 20, 2012 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today 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 in mid-February. In the interim, CTI will continue to work with the CHMP on the Summary of Product Characteristics and other labeling items for Pixuvri. CTI is seeking an authorization to market Pixuvri in the E.U. 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 would address an unmet medical need, as there are no approved therapies for these patients.
In the U.S., the Food and Drug Administration ("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 in the same indication.
About Pixuvri (pixantrone)
Pixantrone 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 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.
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 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 market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of Pixuvri include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with Pixuvri in particular, including, without limitation, the potential failure of Pixuvri to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors as determined by the FDA and/or the EMA, that CTI may not receive a positive opinion regarding the MAA from the CHMP in mid-February 2012 or at all, that the CHMP may reschedule timing of the issuance of its opinion on the MAA, that the CHMP may request additional information from CTI regarding Pixuvri,that CTI may not obtain a license to market Pixuvri in the E.U., that the EMA and/or the European Commission may not formally adopt the CHMP's opinion regarding Pixuvri, that the FDA may not complete the review of the New Drug Application for Pixuvri by the PDUFA goal date of April 24, 2012, that CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling Pixuvri, 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.
Lindsey Jesch Logan
Medical Information Contact:
SOURCE Cell Therapeutics, Inc.