NeoStem Offers Second Data Safety Monitoring Board Review: to Continue with PreSERVE AMI Phase 2 Trial as Planned

NeoStem, Inc. (NYSE: NBS)("NeoStem" or the "Company"), a leader in the fast growing cell therapymarket, today announced that, on March 6, 2013, it received approval tocontinue the PreSERVE AMI Phase 2 clinical trial following its second interimdata and safety review by the Data Safety Monitoring Board (DSMB). ThePreSERVE trial of AMR-001 is a Phase 2, randomized, placebo controlled,double-blind study designed to treat 160 patients and is approved by the FDAto enroll up to 180 patients. AMR-001 is being evaluated for the prevention ofmajor adverse cardiac events following acute myocardial infarction (AMI).Patient enrollment for the PreSERVE trial began in January 2012, and NeoStemanticipates completing enrollment in 2013 with initial data readout six toeight months later."We are pleased that the second external review of our Phase 2 trial dataconfirms that there are no safety signals that would preclude the trial fromcontinuing as planned," said Andrew L. Pecora, M.D., FACP, CPE, Chief MedicalOfficer of NeoStem. "We've learned through our principal investigators thatthe collection of stem cells and administration of AMR-001 is relativelystraightforward for the treatment of patients within 11 days following anacute MI. Thus, we are confident that physicians will be in a position torealize the potential of this technology in the real clinical setting.""The results of our Phase 1 trial, and the large and growing body ofscientific data and clinical experience, support the continued development ofAMR-001," said Jonathan Sackner-Bernstein, M.D., F.A.C.C., Vice President ofClinical Development and Regulatory Affairs of NeoStem. "In early 2012, theCochrane Collaboration published a comprehensive review of clinical trialsthat concluded that safety and efficacy is likely to be observed with the useof autologous bone marrow derived stem cells as treatment for acute ST segmentelevation of myocardial infarction. The Cochrane Review's rigorous analysis ofdata from over 1,700 patients, including Amorcyte's Phase 1 trial, highlightedthe safety and likely benefit of autologous bone marrow hematopoietic stemcell therapy for patients following a heart attack. The Review reported thatthis therapeutic approach preserves heart muscle, lowers the risk of furtherheart attacks, reduces the need for additional invasive procedures, andprevents deaths from cardiovascular disease."