NBS10: Preliminary Phase II data

Preliminary data from the double-blind, U.S. Phase II PreSERVE AMI trial in 161 patients diagnosed with an ST-segment elevation myocardial infarction (STEMI) showed that intracoronary AMR-001 given 5-11 days post-stent placement missed the primary endpoint of improving myocardial perfusion as measured by RTSS using SPECT MPI from baseline to 6 months vs. placebo. NeoStem said it “now believes that SPECT analysis is not sufficiently reliable as an endpoint because of the subjectivity of reading imaging studies” and that it “does not expect that any potential Phase III trial design would include SPECT analysis as a primary endpoint.” The company also noted that FDA guidance said mortality and MACE are the appropriate approvable endpoints to determine efficacy of a cellular therapy for cardiac disease. ...