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Dainippon Sumitomo Pharma Co Ltd Announces BBI608 Phase 1/2 Clinical Study Data


Monday, 3 Jun 2013 07:30pm EDT 

Dainippon Sumitomo Pharma Co Ltd announced that the dose-escalation study results from the Phase 1/2 clinical study on BBI608, an anti-cancer treatment under development, was presented on June 3, 2013 (U.S. time) at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Adverse events for BBI608 were generally mild; the most common being grade 1-2 diarrhea, nausea, anorexia and fatigue with a total of 4 grade 3 events (diarrhea and fatigue), and there were no grade 4 events. MTD was not reached. Hematological toxicity was not observed. The recommended dose for the BBI608 Phase 1/2 clinical study (extension study) was established as 500mg twice daily. For a preliminary efficacy results (RECIST v1.1), the disease control rate (DCR) was found to be 65% (17/26 evaluable patients). In the subset of 18 patients with colorectal cancer (CRC), among those evaluable, DCR was 67%, median progression free survival (PFS) was 14 weeks and median overall survival (OS) was 47 weeks. Median OS for biomarker-positive (nuclear β-catenin and high p-Stat3) CRC patients was 53 weeks and 54 weeks, respectively. 

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