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Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkin's Lymphoma (NHL)
Date:9/11/2007

s trial which could expand the application into the larger indolent NHL market."

Pixantrone in Indolent NHL

Preliminary results from a phase I/II study of pixantrone combined with fludarabine, dexamethasone, and rituximab for patients with relapsed indolent NHL were presented at the American Society of Hematology (ASH) annual meeting in December 2006. Among the 27 patients evaluable for response, study results showed the FPD-R regimen with pixantrone produced an 89 percent overall response rate (ORR) by the Cheson criteria, including 70 percent of patients experiencing a complete response/unconfirmed complete response (CR/uCR; 63 percent, CR and seven percent, u/CR). The estimated median duration of response was 25 months and the estimated progression-free survival rate at three years was 50.4 percent.

In addition, pixantrone was studied in a randomized clinical trial for indolent NHL patients comparing pixantrone in combination with rituximab to rituximab alone, with time to progression (TTP) as the primary efficacy endpoint. The study of 38 relapsed or refractory patients receiving the combination of rituximab and pixantrone had a 60 percent overall improvement in TTP compared to rituximab alone. [SC1] The median TTP estimate for the pixantrone/rituximab recipients was 13.0 months compared to 8.1 months for rituximab alone (hazard ratio 0.13, log rank p<0.001).

Pixantrone in Aggressive NHL

Pixantrone is the subject of two ongoing studies in aggressive NHL, a phase III single agent trial, known as EXTEND (PIX301) and a phase II/III combination study, known as RAPID (PIX203). The EXTEND trial explores the role of single agent treatment as a salvage regimen in patients with relapsed aggressive NHL who have failed at least two prior treatment regimens. Patients are randomized to receive either pixantrone or another single-agent drug of physician's choice currently used for the treatment of this patient population.

The RAPID trial is
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SOURCE Cell Therapeutics, Inc.
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