Allos: FDA approves design of pivotal phase 2 trial of PDX in treatment of T-cell lymphoma

By Lisa Kerner

Charlotte, N.C., Aug. 2 - Allos Therapeutics, Inc. said it has reached an agreement with the Food and Drug Administration under the Special Protocol Assessment process on the design of a pivotal phase 2 trial of its novel, small molecule chemotherapeutic agent PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma.

"We're pleased to have reached agreement with the FDA on the design of this important clinical trial as it provides a well defined pathway for pursuit of marketing approval of PDX," president and chief executive officer Paul L. Berns said in a company news release.

"We expect to move forward as planned with the initiation of enrollment in this trial by the end of the third quarter."

The phase 2, non-randomized, open-label trial will evaluate the safety and efficacy of PDX with concurrent vitamin B12 and folic acid supplementation.

Patients will receive PDX at 30 mg/m2 once every week for six weeks followed by one week of rest per cycle of treatment.

Allos said it plans to enroll 100 evaluable patients at 35 cancer centers in the United States, Canada and Europe.

Interim results from an ongoing phase 1/ 2 study of PDX in patients with relapsed or refractory non-Hodgkin's lymphoma and Hodgkin's disease show evidence of activity in patients with various subtypes of aggressive and chemotherapy resistant T-cell lymphoma.

Allos is a Westminster, Colo., biopharmaceutical company specializing in small molecule therapeutics for the treatment of cancer.

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