Allos says PDX improving patients with non-Hodgkin's Lymphoma

By Ted A. Knutson

Washington, Dec. 12 - Allos Therapeutics, Inc. announced Monday an ongoing phase 1/2 trial of PDX (pralatrexate) in patients with non-Hodgkin's Lymphoma shows PDX has achieved a "remarkably" high complete response rate in a difficult-to-treat, drug-resistant patient population.

"Results seen to date suggest that PDX may offer distinct advantages over current approaches used in the treatment of T-cell lymphoma," said Owen O'Connor, M.D., Ph.D., attending physician, Lymphoma Department, Memorial Sloan-Kettering Cancer Center (MSKCC) and the study's principal investigator.

"We are encouraged by the activity observed in the ongoing phase 1/2 study and believe it provides strong rationale for continued clinical development of PDX in T-cell lymphoma," said Michael E. Saunders, M.D., vice president, clinical development of Allos, in the release. "Our intent is to initiate a multi-center phase 2 study in this setting in the first half of 2006."

Results of the trial were presented Sunday at the 47th annual meeting of the American Society of Hematology.

In this phase 1/2 Memorial Sloan Kettering sponsored study, patients with aggressive non-Hodgkin's lymphoma (diffuse large B- or T-cell lymphoma, mantle cell lymphoma, transformed large cell lymphomas) or Hodgkin's Disease are administered increasing doses of PDX with vitamin B12 and folic acid supplementation. The initial dose level was 30 mg/m2 administered weekly for three weeks, with one week rest. The dose was increased to 30 mg/m2 weekly for six weeks in a seven-week cycle and currently is being administered at 45 mg/m2 weekly for six weeks in a seven-week cycle. There is no limit on the number of prior therapies.

As part of the initial phase 2 study, 16 patients were treated with PDX according to a dosing schedule of 135 mg/m2 of PDX every other week, with dose escalation (15 mg/m2) for patients without significant toxicities. The protocol was amended in July 2004 to explore a weekly dosing schedule beginning at 30 mg/m2 for three weeks in a four-week schedule.

To date, 11 patients have been accrued to the amended phase 1 study at dose levels up to 45 mg/m2, including seven patients with T-cell lymphoma. In total, eight patients with T-cell lymphoma have been treated with PDX, of whom five were evaluable for response.

Notably, four of five evaluable patients with T-cell lymphoma achieved a complete remission within the first cycle, despite being chemotherapy refractory.

Three of four T-cell lymphoma patients remain on treatment and in complete remission four to nine months later.

Moreover, among those patients pre-treated with vitamins, the previously established dose limiting toxicity of stomatitis was eliminated. Little hematological toxicity has been observed. MSKCC investigators are currently enrolling patients in the third dose cohort, 45 mg/m2 of PDX administered weekly for six weeks in a seven week cycle.

Westminister, Colo.-based Allos Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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