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CuraGen and TopoTarget Initiate Phase I/II Clinical Trial of Belinostat (PXD101) Combination Therapy for Acute Myeloid Leukemia
Date:8/28/2007

BRANFORD, Conn., Aug. 28 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN) and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced today the initiation of patient dosing in a Phase I/II clinical trial evaluating belinostat (PXD101), a histone deacetylase (HDAC) inhibitor, in combination with the anthracycline idarubicin for the treatment of Acute Myeloid Leukemia (AML). The trial is being conducted at multiple sites in the European Union.

Patients under the age of 60 with relapsed or refractory AML, or patients over 60 with newly diagnosed or previously treated AML, are eligible for enrollment in the trial. Initially, 24 to 40 patients will be enrolled into one of two treatment arms and receive intravenous treatment with a combination of belinostat and idarubicin. Patients will receive standard doses of idarubicin in combination with either belinostat administered intravenously once daily for five days, or a continuous infusion of belinostat over 24 to 48 hours. Enrollment into the arms will occur in parallel in order to assess safety and define the maximum tolerated dose (MTD) for each treatment regimen. Upon establishing the MTD for each treatment arm, the trial will be advanced into Phase II to further define the safety and efficacy of belinostat in combination with standard doses of idarubicin.

Patients demonstrating complete or partial response, as defined by the Revised Recommendations of the International Working Group, will continue to receive treatment with belinostat until disease progression. The primary objectives for the study include safety, tolerability, and efficacy for each treatment regimen. Secondary objectives include time to response, duration of response, and surviva
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