Allos starts phase 2 study of PDX in patients with T-cell lymphoma

By E. Janene Geiss

Philadelphia, Aug. 29 - Allos Therapeutics, Inc. said Tuesday that it began enrollment of the first patient in Propel, a pivotal multi-center phase 2 study of the company's unique next generation antifolate PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with relapsed or refractory peripheral T-cell lymphoma.

The trial is an international, multi-center, open-label, single-arm study seeking to enroll 100 patients with relapsed or refractory peripheral T-cell lymphoma who have progressed after at least one prior treatment, according to a company news release.

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

The primary endpoint of the study is objective response rate (complete and partial response). Secondary endpoints include duration of response, progression-free survival and overall survival.

The company said it anticipates that patient enrollment at about 35 centers in the United States, Canada and Europe will take about 18 to 24 months to complete.

Interim results from a phase 1/ 2 study of PDX in patients with relapsed or refractory non-Hodgkin's lymphoma and Hodgkin's disease, which is ongoing at Memorial Sloan-Kettering Cancer Center, demonstrated preliminary evidence of activity in patients with various subtypes of aggressive and chemotherapy resistant T-cell lymphoma.

As reported at the 2005 American Society of Hematology annual meeting, four of seven evaluable patients with T-cell lymphoma achieved a complete response following treatment with PDX, despite having failed multiple prior therapies.

The addition of vitamins to the treatment regimen appeared to successfully mitigate the previously established dose limiting toxicity of stomatitis, officials said.

PDX is a novel, small molecule chemotherapeutic agent that inhibits dihdrofolate reductase, a folic acid dependent enzyme involved in the building of DNA and other processes.

Allos is a Westminster, Colo., biopharmaceutical company focused on cancer.

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