Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma ORLANDO, Fla., June 1 /PRNewswire-FirstCall/ -- Intent to treat Analysis results per FDA agreed upon Statistical Analysis Plan Significant Increase in Complete Remission Rates 20% vs. 5.7%; p=0.021 Significant Increase in Overall Response Rate 37.1% vs. 14.3%; p=0.003 Significant increase in percent of all patients whose response lasted greater than or equal to four months 25.7% vs. 8.6%; p=0.012 Significant Increase in Progression Free Survival 4.7 months vs. 2.6 months; p=0.007 Positive trend in Overall Survival even though data not fully mature with median 8.1 month vs. 6.9 month; p=0.544 Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that at the 2009 American Society for Clinical Oncology ("ASCO") Annual Meeting for the first time since the top-line data were released, complete pivotal phase III results of CTI's EXTEND (PIX 301) clinical trial of pixantrone (the "PIX 301 EXTEND trial") in relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") were presented by Principal Investigator, Ruth Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the PIX 301 EXTEND trial who presented the study at ASCO. "Anthracycline-related drugs can be effective salvage agents in aggressive NHL, but our use of them is limited by the significant increase in risk of cardiac failure associated with high cumulative doses of these drugs," said Dr. Pettengell. "These results represent a breakthrough in that pixantrone could extend our ability to use a highly active anthracycline-like drug in such patients and deserves to be examined in anthracycline naive patients as a potential alternative to currently available standard anthracycline drugs." The PIX 301 EXTEND (Expanding the reach of antrhacyclines 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. In the PIX 301 EXTEND trial 57% of the randomized patients were refractory to prior treatments with 50% of patients having failed three prior chemotherapy treatments. More than 70% of the patients on both arms were considered intermediate to high risk by the International Prognostic Index score (>=2). The median prior doxorubicin equivalent dose was approximately 300 mg/m2, the dose that is associated with six cycles of CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy, the standard of care for first line therapy in this disease. Fifty-three percent of pixantrone patients received four or more cycles of therapy compared to a median of three cycles in the comparator arm. The median doxorubicin equivalent dose at the end of therapy was 513 mg/m2 (with a range of 115 mg/m2 to 1003mg/m2). Data from repeated evaluations of Left Ventricular Ejection Fraction ("LVEF") by MUGA (Multi Gated Acquisition Scan) scan demonstrated no consistent dose related decline as has been described for doxorubicin with median LVEF values at a baseline of 58% and at the end of treatment of 59%. Consistent across the primary and subgroup analyses, treatment with pixantrone resulted in superior clinical benefits over standard of care chemotherapy treatment. "We are pleased that the PIX 301 EXTEND trial of pixantrone demonstrated a long-lasting clinical benefit in this heavily pretreated relapsed/refractory group of patients with aggressive NHL and look forward to completing the New Drug Application submission later this month," said James A. Bianco, M.D., Chief Executive Officer of CTI. "Given the lack of approved therapies for this resistant group of patients with aggressive NHL, we believe pixantrone offers a valuable therapy for this unmet medical need." The most common grade 3, 4 adverse event observed on the pixantrone arm was neutropenia in 41.2% of patients versus 19.4% on the comparator arm. However, the incidence of grade 3, 4 febrile neutropenia was only 7.4% versus 3.0% in the comparator arm. Grade 3, 4 infections had a similar incidence in both study arms (18% vs. 13%). Although the grade 3, 4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a slightly higher incidence of serious cardiac disorders in patients treated with pixantrone than among patients who received comparator agents (8.8% vs. 4.5%). Events considered cardiac disorders included cardiac arrest, congestive heart failure, myocardial infarction, cyanosis, pericardial effusion, and tachycardia. The ASCO poster is available at http://www.celltherapeutics.com/investor_updates. In April 2009, CTI began a rolling submission of a New Drug Application ("NDA") with the U.S. Food and Drug Administration (the "FDA") for pixantrone to treat relapsed or refractory aggressive NHL. CTI expects to complete the submission this month and will request priority review which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009. Pixantrone is also now available in Europe on a named patient basis. |
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