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Cell Therapeutics, Inc. (CTI) Projects Zevalin(R) Sales of $15 Million With Cash Flow Breakeven for Commercial Operations in 2008
Date:2/11/2008

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Results of the pixantrone phase III clinical trial in aggressive, relapsed non-Hodgkin's lymphoma (NHL), known as the EXTEND or PIX301 trial, are expected in the summer of 2008. Depending on the results of this trial, CTI may begin a rolling New Drug Application (NDA) submission for pixantrone in the second half of the year. CTI has closed enrollment on its other clinical trials of pixantrone, including the RAPID trial, a first-line randomized phase II study of CHOP-R versus CPOP-R in previously untreated aggressive NHL patients, and the PIX303 trial, a study of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have received at least one prior treatment for indolent NHL.

"Based on feedback from both our partner Novartis and from a panel of oncology experts, all agreed the best step for the Company is to focus resources on obtaining XYOTAX and pixantrone approval with existing or completing phase III trials before making additional substantial investments in alternative indications for these products. Combined with reductions in phase III clinical trials costs for XYOTAX and pixantrone, we are projecting net cash operating expenses of $77 million in 2008," Bianco added.

About Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory NHL. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most seri
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SOURCE Cell Therapeutics, Inc.
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