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Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment
Date:6/1/2009

Panel Discussant Focuses on Longer Duration of Remission among Patients Achieving a Complete Remission with Pixantrone than Complete Remissions Achieved with Standard Chemotherapy

ORLANDO, June 2 /PRNewswire-FirstCall/ -- Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that at the poster and discussion session of the Lymphoma and Plasma Cell Disorders Section at the 2009 American Society of Clinical Oncology ("ASCO") Annual Meeting, new subgroup analysis data were reviewed from the phase III EXTEND (PIX 301) clinical trial of pixantrone (the "PIX 301 EXTEND trial") demonstrating the effectiveness of pixantrone as therapy in patients with aggressive non-Hodgkin's lymphoma ("NHL") for whom anthracycline and related drugs are typically not to be used due to a high risk of cardiac toxicity, including cardiac failure.

Twenty-five of the 70 patients in the PIX 301 EXTEND trial had received prior cumulative doxorubicin doses in excess of the standard 300 mg/m2 associated with six cycles of first line CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) therapy. The median prior exposure of these patients, most of whom had received an anthracycline as part of a salvage regimen, was 386 mg/m2 (with a range of 306 mg/m2 to 778 mg/m2). Following treatment with pixantrone, ten of these 25 patients (40%) achieved a confirmed complete remission ("CR"), unconfirmed remission ("CRu") or partial remission ("PR") (CR=2, CRu= 5, 28%; PR=3, 12%) The lifetime cumulative doxorubicin equivalent dose following pixantrone was 579 mg/m2 (with a range of 361 mg/m2 to 1003 mg/m2). No patient developed a severe reduction (>=20%) in left ventricular ejection fraction (LVEF) and only one patient developed congestive heart failure (CHF). The total cumulative doxorubicin equivalent exposure per treatment cycle for all 68 patients treated with pixantrone is noted in the table below:

           Treatment 
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SOURCE Cell Therapeutics, Inc.
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1. Pixantrone Phase 3 Data to be Presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting
2. Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkins Lymphoma
3. Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for Pixantrone
4. Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkins Lymphoma Trial
5. Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission
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8. 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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10. Pixantrone Shows Activity in a Preclinical Study of Experimental Autoimmune Myasthenia Gravis (EAMG)
11. Pixantrone Versus Doxorubicin in CHOP-R Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Preliminary Results Presented at American Society of Hematology (ASH) Annual Meeting
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