ARTICLE | Clinical News

NeoStem falls on Phase II miss

November 19, 2014 3:34 AM UTC

NeoStem Inc. (NASDAQ:NBS) plunged $2 (30%) to $4.78 on Tuesday after reporting that its NBS-10 stem cell therapy missed a co-primary endpoint in the Phase II PreSERVE AMI trial to treat damaged heart muscle after an ST-segment elevation myocardial infarction (STEMI), and did not lead to significantly reduced major adverse cardiac events (MACE).

NeoStem said the autologous bone marrow-derived stem cells did not lead to a statistically significant increase in myocardial perfusion at six months as measured by gated SPECT myocardial perfusion imaging, a co-primary endpoint. NBS10 also failed to significantly reduce MACE at one year, defined as cardiovascular death, re-infarction, heart failure hospitalization and coronary revascularization, a co-second primary endpoint. ...