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Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial
Date:5/19/2009

Updated Safety data presented at BIO International Convention in Atlanta

ATLANTA, May 19 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) released updated safety data today from its pixantrone phase III 301 EXTEND trial demonstrating the effectiveness of pixantrone in patients with relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) for whom anthracycline-related drugs are typically not to be used due to the increased risk of cardiac failure.

As noted during the presentation of Craig Philips, President of CTI, "The standard chemotherapy regimen (CHOP) for this disease exposes patients to less than or equal to 300mg/m2 of doxorubicin, a dose at which 5.6% of patients are expected to develop congestive heart failure (CHF). At cumulative doses of doxorubicin in excess of 600mg/m2, 48% of patients develop CHF."

"With these background statistics, we examined the occurrence of CHF from any cause among PIX 301 recipients who received prior treatment at standard doxorubicin doses (<=300mg/m2) along with those pixantrone recipients who had received extensive prior doxorubicin treatment compared to historically reported rates when treated with standard doxorubicin," stated Mr. Philips. "Despite patients receiving a median total cumulative doxorubicin equivalent dose of 535mg/m2, the frequency of CHF among PIX 301 recipients was non-dose dependant and was markedly lower than that reported for doxorubicin at similar levels of treatment."

At a cumulative total doxorubicin equivalent exposure of > 600mg/m2, the frequency of CHF among PIX 301 recipients was 4% compared to 48% reported for doxorubicin.

               Incidence Clinical CHF- related or unrelated to drug

    Dose (mg/mg2 doxorubicin         Doxorubicin(1)             Pixantrone
    equivalents)                        N=620                      N=70

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SOURCE  Cell Therapeutics, Inc.
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