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Additional New Data from Satraplatin SPARC Phase 3 Investigational,Trial Presented at ASCO Annual Meeting

gnificant, in favor of the satraplatin arm.

PFS data as observed by the clinical site investigators were also presented today. Compared to the PFS data previously reported, these progression events were not adjudicated by the blinded independent review committee. The hazard ratio for PFS for the intent-to-treat population per investigator observation was 0.58 (95% CI: 0.50-0.67, p = 0.000000000002). Median time to progression was 16.0 weeks for the satraplatin arm versus 6.0 weeks for control. The hazard ratio for PFS for the intent-to-treat population treated with prior Taxotere(R) (docetaxel) per investigator observation was 0.52 (95% CI: 0.42-0.65, p=0.000000002), with a median time to progression of 15.3 weeks for the satraplatin arm compared to 5.6 weeks for control. These data are consistent with the PFS outcomes as adjudicated by the blinded independent review committee.

Safety findings in the SPARC trial were consistent with previous clinical studies involving satraplatin. Myelosuppression (decrease in the production of blood cells by the bone marrow) was the most common adverse reaction associated with satraplatin therapy. Twenty-one percent of patients in the satraplatin arm experienced grade 3 or 4 thrombocytopenia; 14% had grade 3 or 4 leucopenia and 21% had grade 3 or 4 neutropenia. Gastrointestinal disorders were the most frequent non-hematological adverse events (occurring in 57.9% of the patients receiving satraplatin). Eight percent of patients in the satraplatin arm experienced grade 3 or 4 gastrointestinal toxicities, including nausea (1.3%), vomiting (1.6%), diarrhea (2.1%) and constipation (2.1%). Additionally, 5% or less of patients in the satraplatin arm experienced grade 3 or 4 fatigue (1.7%), grade 3 or 4 infections (4.0%) and pulmonary/respiratory grade 3 or 4 toxicities (3.0%).

Preliminary data from Phase 2 trial evaluating satraplatin plus Taxol in non-small cell lung cancer also published in ASCO educational book


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