NeoStem, Inc. Reports Second Data Safety Monitoring Board Review: Continue With PreSERVE AMI Phase 2 Trial as Planned
Published: Mar 07, 2013
NEW YORK, March 7, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the fast growing cell therapy market, today announced that, on March 6, 2013, it received approval to continue the PreSERVE AMI Phase 2 clinical trial following its second interim data and safety review by the Data Safety Monitoring Board (DSMB). The PreSERVE trial of AMR-001 is a Phase 2, randomized, placebo controlled, double-blind study designed to treat 160 patients and is approved by the FDA to enroll up to 180 patients. AMR-001 is being evaluated for the prevention of major adverse cardiac events following acute myocardial infarction (AMI). Patient enrollment for the PreSERVE trial began in January 2012, and NeoStem anticipates completing enrollment in 2013 with initial data readout six to eight months later.