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Topotarget A/S and Spectrum Pharmaceuticals' PTCL Trial Fully Enrolled


Monday, 26 Sep 2011 07:00am EDT 

Topotarget A/S announced that together with Spectrum Pharmaceuticals, it has achieved the target enrollment for the pivotal PTCL trial for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). The two companies have completed the enrollment of a minimum of 100 evaluable relapsed or refractory peripheral T-cell lymphoma (PTCL) patients in the PTCL registration trial. Belinostat, an HDAC inhibitor, is being evaluated, under a Special Protocol Assessment (SPA), as monotherapy treatment for relapsed or refractory PTCL, an indication for which it has been granted Orphan Drug and Fast Track Designation by the United States Food and Drug Administration (FDA). The central review of pathology for all patients entered into the trial is currently ongoing. Topotarget A/S's full-year financial guidance for the fiscal year 2011 is not affected by the news.