SEATTLE, Sept. 15 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) announced today that it has submitted a Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMEA) as part of the required filing process for approval of pixantrone for treating relapsed or refractory, aggressive non-Hodgkin’s Lymphoma (NHL) in Europe. The PIP outlines how the company proposes to study the drug in children in order to benefit child health.
CTI recently received a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 in the U.S. regarding CTI’s New Drug Application (NDA) for pixantrone as potential treatment for relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL).
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.
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 (including the failure to achieve the overall response rate, complete remissions and progression-free survival and the possibility of significant grade 3/4 adverse events, including cardiac disorders) for the treatment of relapsed or refractory aggressive NHL as determined by the FDA, and the potential failure of pixantrone to be approved by the EMEA (whether for a pediatric population or any other population) and that a decision by the FDA is not rendered by April 23, 2010, 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
Cell Therapeutics, Inc.
