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Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission
Date:1/26/2009

SEATTLE, Jan. 27 /PRNewswire-FirstCall/ -- Cell Therapeutics (CTI) (Nasdaq and MTA: CTIC) announced today that after communication with the Food and Drug Administration (FDA), CTI expects to begin submission of a rolling New Drug Application (NDA) and request priority review for pixantrone to treat relapsed aggressive non-Hodgkin's lymphoma (NHL) in the first quarter of 2009. If granted priority review a decision on the NDA could occur before the end of 2009.

"This communication from the FDA is a significant milestone for the Company and for patients with relapsed aggressive NHL as this could be the first drug approved for this unmet medical need," noted James A. Bianco, M.D. Chief Executive Officer of CTI. "With the potential for three drug approvals in 2009 we are on track to meet our objective of cash flow break even in the fourth quarter of this year."

The EXTEND clinical trial was a phase III single-agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma 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.

CTI announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients. Pixantrone treatment also significantly increa
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SOURCE Cell Therapeutics
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3. Cell Therapeutics, Inc. (CTI) Announces Enrollment Complete in Phase III EXTEND (PIX301) Clinical Trial of Pixantrone in Patients With Second or Greater Relapse of Diffuse Large B Cell NHL
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