Belinostat (TopoTarget/Spectrum) success in BELIEF study for PTCL - 28-Sep-2012

The pivotal BELIEF trial (PXD101-CLN-19) evaluating the efficacy and safety of belinostat from Topo Target A/S for the treatment of patients with relapsed/refractory Peripheral T-Cell Lymphoma (PTCL) met its primary endpoint. A Special Protocol Assessment agreement with the FDA requires the BELIEF trial to reach an objective response rate (ORR) of at least 20% and this objective was met. Data from the trial are being further analyzed and are expected to be communicated during Q4 2012. Under the terms of a 2010 license and collaboration agreement, belinostat is currently being developed jointly by Spectrum Pharmaceuticals and Topotarget. Spectrum possesses the commercial rights to market belinostat in North America and India. A New Drug Application for belinostat in PTCL is expected to be filed with the FDA by Spectrum in the first half of 2013.