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Spectrum Pharmaceuticals Inc's Pivotal Trial of Captisol-Enabled (Propylene Glycol-Free) Melphalan Meets Primary Endpoint

Wednesday, 23 Apr 2014 07:00am EDT 

Spectrum Pharmaceuticals Inc:Says its pivotal trial of Captisol-enabled (propylene glycol-free) Melphalan met its primary end points.Phase 2 pivotal trial evaluating CE Melphalan was a multi-center trial evaluating safety and efficacy.Primary objective of study was to determine overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m(2)of CE Melphalan as myeloablative therapy prior to autologous stem cell transplantation (ASCT).Secondary objectives evaluated the efficacy of CE Melphalan in this patient population as measured by multiple myeloma response rate (according to International Myeloma Working Group [IMWG] criteria), and the rates of myeloablation, and engraftment.Primary endpoint of this Phase 2 trial was met, and additional analyses are currently underway.Company plans to file NDA in third quarter. 

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0.01 +0.12%
19 Sep 2014