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Pixantrone Produces 250% Relative Improvement in 1 Year Progression Free Survival for Patients With Relapsed/Refractory, Aggressive Non-Hodgkin's Lymphoma Across All Measured Risk Factors - Updated Follow-Up Data
Date:12/7/2009

ontinues to demonstrate clinical benefit in the follow up period across patient demographics, and risk factors," said James A. Bianco, M.D., Chief Executive Officer of CTI. "We continue to work expeditiously with the FDA as we progress pixantrone through regulatory review to potential approval and commercialization."

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. Other common adverse events (any grade) included infection, anemia, leucopenia, thrombocytopenia, asthenia, pyrexia, and cough. Although the grade 3/4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a higher incidence of serious cardiac disorders in patients treated with pixantrone than among patients who received comparator agents (6/68 or 8.8% vs. 3/67 or 4.5%).

The ASH poster is available at http://www.celltherapeutics.com/investor_updates.

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.

About Pixantrone

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 anthr
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SOURCE Cell Therapeutics, Inc.
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