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NeoStem, Inc.
("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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