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Pixantrone Granted Fast Track Designation by FDA for Relapsed,Indolent NHL Patients

Proposed Phase III Trial Has the Potential to Demonstrate an Effect on a Serious or Life Threatening Aspect of This Disease

SEATTLE, May 07, 2007 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) announced today it received fast track designation from the U.S. Food and Drug Administration (FDA) for pixantrone, a novel anthracenedione, being investigated for the potential treatment of relapsed or refractory indolent non-Hodgkin's lymphoma (NHL). In granting fast track, the FDA noted that "relapsed or refractory indolent NHL is a serious and life threatening condition and is generally considered incurable. Results from a phase I and phase III study in patients with relapsed and/or refractory indolent non-Hodgkin's lymphoma suggest that pixantrone is active in this disease." The FDA also noted that the proposed phase III trial in combination with fludarabine and rituximab "has the potential to demonstrate an effect on a serious or life threatening aspect of this disease."

Prior results demonstrated that the addition of pixantrone to a fludarabine/rituximab-based regimen in relapsed or refractory indolent NHL yielded a 70 percent confirmed response/unconfirmed response (CR/uCR) rate. In that phase I/II study the estimated median duration of response was 25 months (range 2.3 to 43 months) and the estimated progression-free survival (PFS) rate at three years was 50.4 percent. A phase III trial of rituximab compared to rituximab plus pixantrone in relapsed or refractory indolent NHL had a 61 percent overall improvement in time to tumor progression (TTP) compared to rituximab alone (395 days vs. 245 days). In that randomized trial, the median TTP estimate for pixantrone/rituximab was 13.2 months compared to 8.1 months for rituximab alone (hazard ratio 0.13, log rank p< 0.001). The overall response rate in the pixantrone/rituximab arm was 75 percent versus 33 percent in the rituximab arm with a CR rate of 30 percent in the pixantrone/rituximab arm versus 11 p
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