SEATTLE, Dec. 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today its support of the Pharmaceutical Research Manufacturers of America's (PhRMA) "Code on Interactions with Healthcare Professionals, revised July 2008" (PhRMA Code). Adherence to the Code is voluntary for commercial biotechnology and pharmaceutical companies.
"As CTI prepares for the potential launch of pixantrone to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma, we are committed to exchanging information with healthcare professionals in an ethical and responsible manner with the patient's best interests in mind," stated Craig W. Philips, President of CTI. "Our sales representatives will serve as an important resource for healthcare providers and we are focused on providing information about our therapies in a manner that consistently meets or exceeds PhRMA code guidelines."
The PhRMA Code provides guidance on interactions between U.S. healthcare professionals and biotechnology and pharmaceutical companies focusing on appropriate sales and marketing practices and training for company representatives.
The U.S. Food & Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) on February 10, 2010. Pixantrone is a fast track designated product which has been accepted for review by the U.S. Food & Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. Pixantrone also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.
The PIX 301 EXTEND phase III clinical trial in relapsed or refractory aggressive NHL was a single-agent trial of pixantrone in patients who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The results of the trial showed that patients randomized to treatment with pixantrone achieved a significantly higher rate of confirmed and unconfirmed complete response, had a significantly increased overall response rate and experience a significant improvement in median progression free survival compared to patients treated with standard chemotherapy. The most common (incidence greater than or equal to 10%) grade 3-4 adverse events reported for pixantrone-treated subjects across the studies were neutropenia and leucopenia.
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 trading price of the securities of CTI. 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, aggressive NHL as determined by the FDA (including ODAC), 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.
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