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NEW YORK, Sept. 17, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the fast growing cell therapy market, today announced that, on September 13, 2013, the Data Safety Monitoring Board ("DSMB") recommended continuing the PreSERVE AMI Phase 2 clinical trial following a third interim data and safety review. The PreSERVE trial of AMR-001 is a Phase 2, randomized, placebo controlled, double-blind study designed to treat 160 patients. AMR-001 is being evaluated for the preservation of heart function after a severe heart attack.
"We are grateful to the DSMB for their oversight of the study and pleased with the recommendation to continue enrollment," said Douglas W. Losordo, MD, FACC, FAHA, Chief Medical Officer of NeoStem. "Despite advances in therapy for myocardial infarction (MI), post-MI left ventricular dysfunction is still a harbinger of an unfavorable long-term prognosis. AMR-001 has shown promise as a means of preserving heart muscle function after a heart attack and we are pleased to continue to work with our investigators across the U.S. to complete enrollment."
Jonathan Sackner-Bernstein, MD, FACC, Vice President of Clinical Development and Regulatory Affairs of NeoStem, said, "The recommendation to continue with the trial is consistent with a wide range of publications that support the utility of autologous bone marrow derived CD34+ stem cells for treatment of this high risk population. The results from this double-blind, sham/placebo controlled study will define the path forward for this promising therapy."
"We are very excited and encouraged by the enrollment progress of the PreSERVE Phase 2 clinical trial," said Dr. Robin L. Smith, Chairman and CEO. "We are on track to complete patient enrollment for this trial in 2013 with data read out 6-8 months after the last patient is infused."
About NeoStem, Inc.
NeoStem, Inc. ("NeoStem" or the "Company") is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy products as well as operating a contract development and manufacturing organization providing services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue-generating service provider business provides the Company with capabilities for cost effective in-house product development and immediate revenue and cash flow generation.