18 month Follow-up Data on Phase III Study of Pixantrone in Late Stage Relapsed or Refractory, Aggressive Non-Hodgkin's Lymphoma Continues to Demonstrate Significant Improvement in Complete Remission and Progression Free Survival Over Standard Chemotherapy
Update Also Demonstrates 3.3-month Improvement over Standard Chemotherapy in Median Overall Survival
SEATTLE, Sept. 16 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today released updated 18-month follow-up clinical data for its phase III EXTEND (PIX 301) trial of pixantrone (BBR2778) for patients with advanced, relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). Responses were evaluated by an Independent Assessment Panel that was blinded to patient assignment.
The table below shows the primary end of treatment data analyses previously reported and the new updated 18 month efficacy data analyses. This data is part of CTI's presentation today at the BioCentury NewsMakers conference at 10:30 AM ET.
End of Treatment 18 Month Follow-Up ---------------- ------------------ CR/CRu CR/CRu ---------------- ------------------ Pixantrone 20.0% 25.7% Control 5.7% 7.1% P Value 0.021 0.005 ORR ORR ---------------- ------------------ Pixantrone 37.1% 40.0% Control 14.3% 14.3% P Value 0.003 0.001 End of Treatment 18 Month Follow-Up ---------------- ------------------ Progression Free Progression Free Survival Survival ---------------- ------------------ Pixantrone 4.7 months 5.6 months Control 2.6 months 2.6 months P Value 0.007 (HR = 0.60) 0.002 (HR = 0.56) Median Overall Median Overall Survival Survival ---------------- ------------------ Pixantrone 8.1 months 10.2 months Control 6.9 months 6.9 months P Value 0.54 (HR = 0.88) 0.3 (HR = 0.82)
"We continue to be impressed by the durability of responses in the pixantrone treatment arm which seemed to improve during the study follow up period, compared to the standard chemotherapy recipients - whose responses and duration of response are largely unchanged from the initial assessment period," noted James A. Bianco, M.D., Chief Executive Officer of CTI. "We are also encouraged by the increase in the overall survival estimates, especially among those patients whose histologic diagnosis was verified by independent pathologists where 40% of pixantrone recipients were alive, compared to 27% for standard chemotherapy at the 1 year landmark period. We plan to submit these updated safety and efficacy data to our NDA as part of the 120 Day update."
The FDA typically receives updated clinical study data 120 days following the initial NDA submission.
The most common (incidence greater than or equal to 20%) adverse reactions reported for pixantrone-treated subjects were neutropenia, infection, anemia, leucopenia, thrombocytopenia, asthenia, pyrexia, and cough.
Pixantrone has been accepted for standard review by the Food & Drug Administration (FDA), with fast track status with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
BioCentury's NewsMakers in the Biotech Industry Conference CTI Presentation: Wednesday, September 16, 2009 10:30 a.m. Eastern /7:30 a.m. Pacific /6:30 p.m. Central European Audio webcast with slides at www.celltherapeutics.com About the EXTEND (PIX301) Clinical Trial
The EXTEND clinical trial is a phase III single agent trial of pixantrone for patients with relapsed or refractory, aggressive nonHodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial was conducted at 130 sites in 17 countries. 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. The trial was designed to examine the complete remission (CR) or unconfirmed complete remission (uCR) rate, time to tumor progression, and overall survival. The study was conducted under a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) and pixantrone has received fast track designation for this indication.
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. Pixantrone has been granted fast track status designation.
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 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 overall response rate, complete remissions and progression-free survival and the possibility of significant grade 3, 4 adverse effects, including cardiac disorders) for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA, that CTI does not submit the 18-month follow-up data to the FDA as part of the 120-day update, and the possibility that the follow-up data does not demonstrate continued improvement in the primary and secondary endpoints, 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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Posted: September 2009