Allos reaches SPA agreement with FDA for FOLOTYN Phase 3 trial in PTCL

Mar 4 2011

Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of the Company's Phase 3 clinical trial of FOLOTYN^® (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL). The study will seek to enroll newly diagnosed patients with PTCL who have achieved a response following initial treatment with a CHOP-based therapy. 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.

"We are pleased to have reached agreement with the FDA on the design of this pivotal Phase 3 trial of FOLOTYN as part of the first line treatment of patients with PTCL," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. "This important study has the potential to support the conversion of our current accelerated approval in the U.S. to a full approval and expand FOLOTYN's indication to the first-line setting. The study further demonstrates our commitment to the medical community and patients to explore the full potential of FOLOTYN and improve outcomes for patients with PTCL."

This Phase 3, randomized, multi-center, international clinical trial will seek to establish the safety and efficacy of sequential FOLOTYN versus observation in patients with previously undiagnosed PTCL who have achieved a response following initial treatment with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CHOP-based chemotherapy. The co-primary endpoints will be progression-free survival and overall survival. The Company expects to initiate this Phase 3 clinical trial of FOLOTYN in 2011.

In September 2009, FDA granted accelerated approval of FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory PTCL. This approval was based on overall response rate from the Company's pivotal Phase 2 trial known as PROPEL. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated. FOLOTYN is the first and only drug approved by the FDA for this indication. FDA's accelerated approval program allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. In connection with the accelerated approval, the Company is required to conduct post-approval studies that are intended to verify and describe FOLOTYN's clinical benefit in patients with T-cell lymphoma. An updated analysis of data from PROPEL was recently published in the Journal of Clinical Oncology.