SEATTLE, April 21 Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) (the "Company") today announced the European Medicines Agency (the "EMEA") Pediatric Committee (the "PDCO") recommended the Company submit an updated Pediatric Investigation Plan ("PIP") for pixantrone following discussions with the Company about the preclinical and clinical pixantrone data, including PIX301, and the desire to explore the potential benefits pixantrone may offer to children with hematologic cancer. The Company expects to submit a revised PIP to the EMEA by the end of the second quarter of 2010. The PIP outlines how the Company proposes to study the drug in children in order to benefit child health.
"We were pleased and encouraged that the pediatric experts on the PDCO believe that there is an important need for a less toxic and effective anthracycline-like agent, not only in lymphoma and also potentially in other tumors, and that it is important that pixantrone be evaluated in a pediatric population given its potential to fulfill this need," said Jack Singer, M.D., Chief Medical Officer of the Company. "The PDCO was very helpful in outlining the type of phase I and phase II studies they would like to see included in our Marketing Authorization Application (MAA) for pixantrone and that these studies could be deferred until after the potential MAA approval next year."
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 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, the Company 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 trading price of the Company'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 EMEA, that the Company may not submit the PIP by the end of the second quarter of 2010, that the EMEA may not accept the PIP, that the Company's MAA may not be approved by the EMEA by next year, that we may not be allowed to defer the phase I and phase II clinical trials, and the Company'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 the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, the Company 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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