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January 8, 2014
08:40 EDTCYTRCytRx reports additional analyses supporting results from Phase 2 trial
CytRx reported positive results from additional statistical analyses that further support the previously announced highly positive top-line efficacy results from a multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas. Additional analysis determined hazard ratios for the primary endpoint of progression-free survival by both investigators at study sites and by a blinded radiology review performed at an independent central laboratory. The hazard ratio for investigator-read scans is 0.37, reflecting a 63% reduction in the risk of disease progression; and the hazard ratio for central lab scans is 0.59, reflecting a 41% reduction in the risk of disease progression. Hazard ratios the likelihood that the study endpoint will be reached during a given period are an important measure of the reliability and uniformity of the absolute data for PFS, as presented below. Hazard ratios where the upper limit is less than 1 indicate that there is a significant difference between the two study groups. CytRx also reported that a Kaplan-Meier analysis of the trial results, which describes the time it takes for tumors to progress in individual patients, showed significant improvement in subjects treated with aldoxorubicin versus subjects treated with doxorubicin. CytRx expects to present full study results for this clinical trial at the American Society for Clinical Oncology Meeting in June, 2014 in Chicago, Illinois.
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