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News Breaks | | | | March 7, 2013 | | 07:34 EDT |  | NBS | NeoStem says received approval to continue PreSERVE AMI Phase 2 trial
NeoStem announced that, on March 6, 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. 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. 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. 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 the company. | |
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News For NBS From The Last 14 Days Check below for free stories on NBS the last two weeks. |
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| May 16, 2013 | | 07:38 EDT | | NBS | NeoStem announces geographic expansion of IP coverage of AMR-001
 Subscribe for More Information | | | May 9, 2013 | | 16:46 EDT |  | NBS | NeoStem reports Q1 EPS (5c), two estimates (5c)
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