Healthcare Industry News: IDIS
News Release - May 5, 2009
Pixantrone Now Available in Europe on a Named-Patient BasisCell Therapeutics and IDIS Partner to Accelerate Patient Access to Pixantrone through Program
SEATTLE, May 5 (Healthcare Sales & Marketing Network) -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today announced that pixantrone is now available on a named-patient basis in Europe. Pixantrone will be supplied by IDIS to healthcare professionals for the treatment of individual patients with aggressive non-Hodgkin's lymphoma (NHL) that has either relapsed after standard therapies or is refractory to them. We know of no therapy that has previously been shown to be effective treatment for such patients.
"CTI has worked hard to make pixantrone available in Europe at the prescriber's request as it provides an option for these difficult to treat aggressive NHL patients," noted Craig Philips, President of CTI. "We continue to work toward potential approval of pixantrone at the end of 2009 in the United States and expect to complete the submission of the New Drug Application to the Food & Drug Administration this quarter."
"Our experience with pixantrone has been positive with patients achieving a complete response where such a result was not achievable with other treatments," said Prof. Pier Luigi Zinzani, M.D., Institute of Hematology and Oncology, University of Bologna. "I am pleased that it is now available on a named-patient basis as it has the potential to address a significant unmet need in this heavily pretreated patient population."
A named-patient program is a compassionate use drug supply program under which physicians can legally supply investigational drugs to qualifying patients. Under a named-patient program, investigational drugs can be administered to patients who are suffering from serious illnesses prior to the drug being approved by the European Medicines Evaluation Agency. "Named-patient" distribution refers to the distribution or sale of a product to a specific healthcare professional for the treatment of an individual patient. In Europe, under the named-patient program the drug is most often purchased through the national health system.
Contact Information for Program:
Licensed healthcare professionals in Europe treating individual patients with relapsing or refractory aggressive non-Hodgkin's lymphoma interested in pixantrone should contact:
Tel: +44 (0) 1932 824 123
Fax: +44 (0) 1932 824 323
Additionally, more information can be found at http://www.celltherapeutics.com/pixantrone_europe
Pixantrone (BBR 2778), is a novel major groove binder 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 has been designed to reduce the potential for these severe cardiotoxicities without sacrificing anti-cancer activity. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.
IDIS is the world leader in the development and implementation of named-patient programs and has a proven track record of working in strategic partnership with US-based companies to bring new drugs to Europe for the first time. IDIS supports customers in over 100 countries, supplying more than 400 different medicines per month and responding to more than half a million requests on a named-patient basis to medical professionals worldwide. For more information on IDIS please visit their website at http://www.idispharma.com.
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. 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 results of complete safety information, the failure to receive anticipated number of requests for pixantrone to treat specific patients, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the possibility that the New Drug Application submission will not be completed in the second quarter of 2009, that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in late 2009, 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, 8-K, and 10-Q. 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.
Source: Cell Therapeutics
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