Cell Therapeutics, Inc. Submits Day 120 Response for Pixantrone Marketing Authorization Application to European Medicines Evaluation Agency; Potential Q1 2012 Opinion on Approval
Published: Aug 23, 2011
SEATTLE, Aug. 23, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that it has submitted its response to the Day 120 List of Outstanding Issues to the European Medicines Agency's (the "EMA") Committee for Medicinal Products for Human Use ("CHMP") in regards to CTI's Marketing Authorization Application for pixantrone (the "MAA") to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL"). With this submission, CTI expects to receive a CHMP opinion regarding approvability of pixantrone during the first quarter of 2012.
"We have now submitted answers to the CHMP list of questions moving pixantrone a step closer to potential approval," said James A. Bianco, CEO of CTI. "Following an encouraging meeting with the EMA earlier this year and based on recommendations from the rapporteurs, we requested and received an extension to answer all the EMA's questions in the Day 120 letter. We believe we have been able to provide quality responses to each of the questions posed and we expect this positions us to receive an opinion by the early next year. If the opinion is positive, we expect that the commercial launch of pixantrone in Europe could occur as early as the first half of 2012."
In the United States, CTI expects to resubmit its New Drug Application for pixantrone (the "NDA") to the U.S. Food and Drug Administration (the "FDA") during the fourth quarter of 2011 and the FDA has indicated the NDA would receive a six month review resulting in a decision on approval of the NDA by the FDA in the United States as early as April 2012.
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 diffuse large 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 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 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 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 an opinion regarding approvability of pixantrone from the CHMP in the first quarter of 2012, that the CHMP may request additional information from CTI regarding pixantrone, that CTI may not receive a positive opinion from the CHMP, that CTI may not be able to commence commercialization of pixantrone in the first half 2012, that CTI may not resubmit the NDA for approval to the FDA during the fourth quarter of 2011, that the FDA's review of the NDA may take longer than six months, that the FDA may not approve the NDA as early as April 2012 or at all, 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.
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SOURCE Cell Therapeutics, Inc.