NeoStem, Inc. (NYSE: 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.
“We are pleased that the second external review of our Phase 2 trial data confirms that there are no safety signals that would preclude the trial from continuing as planned,” said Andrew L. Pecora, M.D., FACP, CPE, Chief Medical Officer of NeoStem. “We’ve learned through our principal investigators that the collection of stem cells and administration of AMR-001 is relatively straightforward for the treatment of patients within 11 days following an acute MI. Thus, we are confident that physicians will be in a position to realize the potential of this technology in the real clinical setting.”
“The results of our Phase 1 trial, and the large and growing body of scientific data and clinical experience, support the continued development of AMR-001,” said Jonathan Sackner-Bernstein, M.D., F.A.C.C., Vice President of Clinical Development and Regulatory Affairs of NeoStem. “In early 2012, the Cochrane Collaboration published a comprehensive review of clinical trials that concluded that safety and efficacy is likely to be observed with the use of autologous bone marrow derived stem cells as treatment for acute ST segment elevation of myocardial infarction. The Cochrane Review’s rigorous analysis of data from over 1,700 patients, including Amorcyte’s Phase 1 trial, highlighted the safety and likely benefit of autologous bone marrow hematopoietic stem cell therapy for patients following a heart attack. The Review reported that this therapeutic approach preserves heart muscle, lowers the risk of further heart attacks, reduces the need for additional invasive procedures, and prevents deaths from cardiovascular disease.”
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