NEW ORLEANS, Dec. 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that Ruth Pettengell, M.D. of St. George's Hospital, University of London during a session at the 2009 American Society of Hematology ("ASH") Annual Meeting updated results from the pivotal phase III EXTEND (PIX 301) clinical trial of pixantrone (the "PIX 301 EXTEND trial") in relapsed or refractory, aggressive non-Hodgkin's lymphoma ("NHL") patients who have failed 2 or more prior therapies. Updated analyses with additional follow-up data were conducted; these analyses and additional follow-up data support the initial clinical trial results. Subgroup analyses examining the effect of age, IPI score, disease status, or prior anthracycline doses on Progression Free Survival (PFS) demonstrated that pixantrone consistently improved PFS across subgroups compared with other chemotherapy agents. With patients in follow-up period at least 9 months from end of treatment, pixantrone provided a 250% relative improvement in 1 year PFS (21% Vs 6%) over comparator and a 115% increase in median overall PFS (5.6 months Vs 2.6 months, p=0.002, HR =0.56). The benefit on PFS was independent of risk factors. At 21 months, 14% of pixantrone patients remained free from disease progression versus 3% in the comparator arm.
"The results of the PIX301 trial continue to impress me as we gain additional follow-up data and information from exploratory sensitivity analyses," noted Dr. Ruth Pettengell, the principal investigator on the study. "The robustness of the drug's effect on prolonging progression free survival across all important risk factors lends to the strength and credibility of the clinical benefit provided to patients in the trial."
The PIX 301 EXTEND (Expanding the reach of anthracyclines with piXanTronE in relapsed or refractory aggressive Nhl Disease) trial was a phase III single-agent trial of pixantrone for patients with relapsed or refractory, aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician.
Results of the PIX301 phase III trial presented demonstrated improvement across primary and secondary endpoints of the study at a minimum of nine-month follow-up from end of treatment. Pixantrone produced CR / CRu rate of 25.7% versus 7.1% for the comparator arm, p-value = 0.005. Overall response rate also increased significantly in patients that received pixantrone (40.0% pixantrone arm versus 14.3%, p-value=0.001). Median PFS increased 115% to 5.6 months for pixantrone arm compared to 2.6 for comparator arm, p-value = 0.002 and HR=0.56. Additionally, a positive trend was seen in overall survival with a 48% increase in median overall survival for the pixantrone arm (10.2 months) versus the comparator arm (6.9 months).
Results presented also included a patient subgroup analysis demonstrating that complete response (CR), partial response (PR) and PFS were robust irrespective of risk factors or prior therapy. Pixantrone also provided superior disease control rates over comparator arm with 22 of comparator recipients progressing within the first evaluation point versus 14 for pixantrone recipients.
Despite 50% of patients exceeding cumulative lifetime anthracycline limits (501 - 900 mg/m2), only two cases of congestive heart failure on independent cardiologist assessment were attributed to pixantrone, occurring at lowest drug exposure (<501mg/m2). The follow-up period for the study is ongoing.
"We are pleased that the PIX 301 EXTEND trial of pixantrone not only met its study objective but continues 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.
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. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.
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 (including the failure to achieve the progression free survival, overall survival, overall response rate and complete remissions) for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA , 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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