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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

e rates of 30% in this population of patients would represent a significant advance in the treatment of aggressive NHL and commented that that while numerically higher, the overall incidence of cardiac events were lower than expected in this patient group with substantial prior doxorubicin exposure reflected by no significant change in ejection fraction from baseline to end of treatment.

"This data demonstrates that pixantrone can induce durable complete remissions not only in patients previously treated with standard front-line doxorubicin, but even in patients who received an anthracycline as part of a salvage regimen. Resistance to rituximab was not associated with resistance to pixantrone. In patients with high cumulative prior doxorubicin exposure, the frequency of severe cardiac toxicity following up to six cycles of additional pixantrone was lower than would be expected based on historical comparisons to studies of doxorubicin," said James A. Bianco, M.D., Chief Executive Officer of CTI. "We are pleased with these results as they underscore the potential for pixantrone in this difficult to treat patient population for whom few options exist."

About the PIX301 EXTEND Trial

The PIX 301 EXTEND clinical trial was a phase III single-agent trial of pixantrone for patients with relapsed or refractory, aggressive NHL 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 previously announced that its pivotal phase III EXTEND (PIX 301) trial of pixantrone had achieved its primary endpoint with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed (CR) and unconfirmed complete remissions (CRu)
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SOURCE Cell Therapeutics, Inc.
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