PreSERVE AMI Phase 2 Trial With AMR-001 Will Continue as Planned
New York, March 17, 2014 – NeoStem, Inc. (NASDAQ:NBS) (“NeoStem” or the “Company”), a leader in the emerging cellular therapy industry, today announced that, on March 11, 2014, the Data Safety Monitoring Board (“DSMB”) recommended continuing the PreSERVE AMI Phase 2 clinical trial following a fourth interim data and safety review. The PreSERVE trial of AMR-001 is a Phase 2, randomized, placebo controlled, double-blind study designed to enroll 160 patients. AMR-001 is being evaluated for the preservation of heart function after a severe heart attack. Full enrollment has been completed for the trial and data will be available in the second half of 2014.
Dr. Andreas Zeiher, an international expert in the development of cell based therapy for acute myocardial infarction (AMI) and principal investigator of a study published last month in the European Heart Journal, has demonstrated that administration of autologous bone marrow derived cells expressing the CXCR4 receptor, five to ten days after an AMI, significantly reduces the cumulative incidence of major adverse clinical cardiac events, including death, heart failure and recurrent cardiac ischemia1. These data further support the ongoing development of NeoStem’s lead product candidate, AMR-001, an autologous bone marrow derived CXCR4 expressing cell that was shown in a Phase 1 trial to induce new blood vessel growth and preserve heart muscle function after a severe heart attack.
“We are grateful to the DSMB for their oversight of the study and pleased that the continued patient follow-up has yielded no safety concerns,” said Dr. Robin L. Smith, Chairman and CEO of NeoStem. “We are also encouraged by Dr. Zeiher’s recent study results which provide further support that the ability of AMR-001 to induce blood vessel growth and preserve heart muscle function will lead to significantly fewer adverse clinical cardiac events. ”
1. Assmus, B., et al. (2014). Long-term clinical outcome after intracoronary application of bone marrow-derived mononuclear cells for acute myocardial infarction: migratory capacity of administered cells determines event-free survival. European heart journal, epub ahead of print.