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Additional Efficacy Data from Satraplatin SPARC Phase 3,Investigational Trial Presented at Annual Meeting of American,Urological Association

the placebo arm. The hazard ratio was 0.64 (95% CI: 0.51-0.79, p<0.001), which translates into a 36% reduction in the relative risk of pain progression. These results were consistent across multiple pre-defined subsets of patients, including patients treated with prior Taxotere(R) (docetaxel). All pain progression events were assigned by a blinded independent review committee. Complementing the time to pain progression data, pain response rates were 24.2 percent for the satraplatin plus prednisone arm (N=351) compared with 13.8 percent for the placebo arm (N=181) (p=0.005). Pain response rates for patients treated with prior Taxotere were 25.7 percent for the satraplatin arm compared with 13.1 percent for control (p<0.015). All of the findings presented today continue to build on the data previously presented from the SPARC trial.

Pain response was assessed by patients using a weekly present pain intensity (PPI) and analgesic score. The PPI score was defined according to the McGill-Melzack questionnaire with 0 = no pain, 1 = mild pain, 2 = discomforting pain, 3 = distressing pain, 4 = horrible pain and 5 = excruciating pain. The criteria for pain response are a greater than or equal to 2 point reduction in the patients' weekly PPI score from baseline and maintenance of the two point reduction for at least five consecutive weeks in the setting of a stable or decreasing weekly analgesic score compared to baseline. Patients were evaluable for pain response if their baseline PPI score was greater than or equal to one and had completed four consecutive weekly assessments of PPI and analgesic scores during the study treatment.

Safety findings in the SPARC trial were consistent with previous clinical studies involving satraplatin. The most common adverse reactions consisted of myelosuppression (bone marrow functions): Twenty-one percent of patients in the satraplatin arm experienced grade 3 or 4 thrombocytopenia; 14 percent had leucopenia and 21 percent had n
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