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Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for Pixantrone
Date:2/10/2009

cyclines. 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.

"We are pleased to be working with Cell Therapeutics to ensure that those patients with non-Hodgkin's Lymphoma who do not respond to current available therapies have access to pixantrone through a named patient program," said Natalie Douglas, CEO, IDIS. "CTI's potentially life-saving medicine can offer these patients renewed hope for remission. We are deeply committed to work in partnership with pharmaceutical and biotechnology companies to give physicians and their patients access to new and innovative medicines through regulated and responsible channels."

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 increased the overall response rate (CR/CRu+PR) with (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). In January, 2009 CTI announced preliminary results that show patients treated with pixantrone experienced a statistically significant improvement in median progression-free survival, compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, hazard ratio = 0.6; p = 0.0074, pixantrone vs. standard chemotherapy) based on an intent to treat analysis. PFS, CR/CRu and ORR were determined by an independent
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SOURCE Cell Therapeutics, Inc.
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