Enrollment complete in Spectrum Pharmaceuticals' belinostat pivotal trial for PTCL

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that it has achieved the target enrollment of the minimum of 100 evaluable relapsed or refractory peripheral T-cell lymphoma (PTCL) patients in the BELIEF registration trial. Belinostat, a novel 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 U.S. Food and Drug Administration (FDA). Central review of pathology for all patients entered onto the trial is currently ongoing.

"We are pleased to announce that belinostat's pivotal, registrational trial in relapsed/refractory PTCL has achieved its target enrollment," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Belinostat is a novel HDAC inhibitor that has the potential to play an important role in therapy for PTCL, an often lethal disease with significant unmet medical need, and in a variety of other indications. It has shown to be active as a single agent and in combination with other chemotherapeutic agents in multiple clinical trials. We plan to file a New Drug Application in 2012. If approved, we believe belinostat will add value to our existing hematology/oncology portfolio, increase our current sales efforts in hematology/oncology, and demonstrate our commitment to developing novel treatments for lymphoma."