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March 17, 2014
07:40 EDTNBSNeoStem reports fourth data safety monitoring board review of PreSERVE AMI trial
NeoStem announced that, on March 11, the Data Safety Monitoring Board, or 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. 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.
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March 2, 2015
16:09 EDTNBSNeoStem provides 2015 outlook
In 2015, NeoStem's management expects significant additional achievements. The Company's milestones and goals for the year include: Randomization of the first patient for the Intus Phase 3 trial for NBS20 in the second quarter of 2015; Release of one-year data from PreSERVE AMI Phase 2 trial for NBS10 on March 15, 2015 at the Annual Scientific Sessions of the American College of Cardiology; Finalization of decision on next development steps for NBS10 based on PreSERVE primary analysis results in the second half of 2015; Initiation of a Phase 2 study for which NeoStem has received FDA agreement on the protocol to evaluate in adolescents the use of NBS03D, a Treg-based therapeutic being developed to treat type 1 diabetes, in late 2015 or 2016 depending on resource availability; Further exploration of means by which the Company can take advantage of new regulations in Japan that permit conditional approval for regenerative medicine products that show sufficient safety evidence and signals of efficacy; Continued growth of the Company's client services business; Advancement of initiatives to lower costs and improve efficiency of manufacturing in anticipation of production for NeoStem's own products and those of its clients.

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