Lintuzumab Ph IIb AMD trial completes enrollment

US drug developer Seattle Genetics has completed patient enrollment in a Phase IIb trial of lintuzumab (SGN-33) in combination with low-dose  cytarabine chemotherapy for patients with acute myeloid leukemia.

"We are pleased to have achieved our enrollment goal of 210 patients in  this global Phase IIb trial in less than 18 months," said Thomas  Reynolds, chief medical officer of the firm. "This trial is designed to  determine if combining lintuzumab with a low-dose regimen of  chemotherapy extends survival in older AML patients, a setting where  there are limited treatment alternatives and patients have a median  survival of less than six months. We anticipate that data from the  trial, which is event-driven, will be available in the first half of  2010," he added.

The lintuzumab Phase IIb randomized, double-blind, placebo-controlled  study evaluating whether the combination regimen of lintuzumab and  low-dose cytarabine chemotherapy extends overall survival compared to  low-dose cytarabine alone in previously untreated AML patients age 60  and older who decline intensive chemotherapy. The primary endpoint of  the study, which is being conducted at more than 80 clinical sites  worldwide, is overall survival.