NeoStem is developing therapies to address ischemia through our CD34 Cell Program. Ischemia occurs when the supply of oxygenated blood in the body is restricted. Our therapeutics seek to reverse this restriction through the development and formation of new blood vessels.
AMR-001 is being developed to treat damaged heart muscle following an acute myocardial infarction (“AMI” or heart attack). In December 2013, the Company completed enrollment in its PreSERVE AMI study, a randomized, double-blinded, placebo-controlled Phase 2 clinical trial testing AMR-001. We expect data read out in 2H 2014.
If approved by Food and Drug Administration ( the “FDA”) and/or other worldwide regulatory agencies and following successful completion of further trials, AMR-001 would address a significant medical need for which there is currently no effective treatment, potentially improving longevity and quality of life for those suffering a STEMI (a certain type of heart attack), and positioning the Company to capture a meaningful share of this worldwide market.