Enrollment commences in Allos' FOLOTYN Phase 3 trial for peripheral T-cell lymphoma

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).

"We are pleased to be initiating this Phase 3 trial, which has the potential to expand the clinical utility of FOLOTYN into the first-line treatment setting," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. "CHOP and CHOP-based treatments are the most commonly used therapeutic regimens for patients with newly diagnosed PTCL; however, a majority of these patients progress or relapse following CHOP. This Phase 3 study will explore the potential for FOLOTYN to improve outcomes for these patients."

FOLOTYN was approved for the treatment of patients with relapsed or refractory PTCL in the United States under the FDA's accelerated approval program, which allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. As a condition of approval, Allos is required to conduct post-approval studies that are intended to verify and describe the clinical benefit of FOLOTYN in patients with T-cell lymphomas and assess whether FOLOTYN poses a serious risk of altered drug levels resulting from organ impairment. The Phase 3 study of FOLOTYN in newly diagnosed patients with PTCL following initial treatment with CHOP or a CHOP-like regimen is one of the Company's post-marketing requirements. If successful, the data are intended to support an expanded indication for FOLOTYN in the United States in this patient population and to convert the current accelerated approval for relapsed and/or refractory PTCL to a full approval. The data are also intended to support global regulatory submissions for FOLOTYN for this patient population outside the United States.