TopoTarget A/S Now Initiates Recruitment of Patients in Its First Pivotal Trial of Belinostat in Peripheral T-Cell Lymphoma (PTCL)

COPENHAGEN, Denmark, Dec. 18, 2008 (GLOBE NEWSWIRE) -- TopoTarget A/S (Copenhagen:TOPO) announces the opening of patient recruitment in the pivotal study intended for registration of belinostat as monotherapy in the treatment of patients with Peripheral T-Cell Lymphoma (PTCL), a haematological malignancy associated with poor prognosis. The trial will enrol approximately 120 patients. TopoTarget has a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA) where the design of the study has been agreed. Furthermore a Fast Track designation has been granted by the FDA for the development of belinostat in this indication which supports TopoTarget's rapid market entry strategy. There is currently no standard therapy approved specifically forPTCL.