Allos Therapeutics, Inc. Initiates Phase 3 Registration Trial of FOLOTYN(R) in Newly Diagnosed Patients with Peripheral T-Cell Lymphoma Following Treatment with a CHOP-based Regimen
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced the enrollment of the first patient in a Phase 3 randomized clinical trial (PDX-017) evaluating FOLOTYN® (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL). This study is open to enroll newly diagnosed patients with PTCL who have achieved an objective response following initial treatment with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or a CHOP-like regimen. Earlier this year, Allos reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process on the design of this Phase 3 trial. The SPA provides FDA agreement that the study design and planned analysis of this Phase 3 trial adequately address the objectives necessary to support a regulatory submission. FOLOTYN, a folate analogue metabolic inhibitor, is approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).