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January 28, 2013
07:05 EDTSPPISpectrum presents Belinostat safety profile at T-Cell Lymphoma Forum
Spectrum Pharmaceuticals announced safety findings from the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase inhibitor. As featured in an oral presentation at the T-Cell Lymphoma Forum held in San Francisco, January 24-26, the BELIEF trial safety evaluation showed belinostat had an acceptable safety profile in patients with relapsed/refractory peripheral T-cell lymphoma, including patients who have received a previous allogeneic or autologous stem cell transplant. The BELIEF trial is evaluating the efficacy and safety of intravenous belinostat for the treatment of patients with R/R PTCL. As announced in December 2012, the BELIEF trial surpassed an objective response rate of at least 20% in these patients, the study’s primary efficacy endpoint as established under a Special Protocol Assessment agreement with the FDA.
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May 15, 2013
19:34 EDTSPPIOn The Fly: After Hours Movers
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11:16 EDTSPPIOptions with decreasing implied volatility: RAX CSC SPPI MBI PANL
May 9, 2013
07:09 EDTSPPISpectrum reports Q1 EPS (5c), consensus (16c)
Reports Q1 revenue $38.7M, consensus $36.42M. Says pivotal data in relapsed/refractory peripheral T-cell lymphoma from late-stage drug Belinostat to be presented as an oral presentation at ASCO 2013; the company expects to submit an NDA this summer. Company expects enrollment in the Captisol-enabled melphalan study in multiple myeloma to be completed in 2013, with NDA submission in 2014.

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