Date: 2015-03-16
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American College of Cardiology’s 64th Annual Scientific Session and Expo, in San Diego, California.
Company: NeoStem (USA - NY)
Product: autologous CD34+ cells (NBS10)
Action
mechanism: cell therapy
Disease: ST Segment Elevation Myocardial Infarction
Therapeutic area: Cardiovascular diseases
Country: USA
Trial
details: PreSERVE AMI is a randomized, double-blind, placebo-controlled clinical trial of intracoronary infusion of autologous CD34 cells in patients with left ventricular dysfunction post-ST elevation myocardial infarction (STEMI). The trial included 161 subjects at 60 sites in the United States, randomized 1:1 between treatment and placebo arms. Eligible patients presented with acute STEMI, had successful stenting of the infarct-related artery and had left ventricular dysfunction 4 days after AMI. Primary endpoints include occurrence of SAEs and MACE (defined as cardiovascular death, re-infarction, heart failure hospitalization, and coronary revascularization) through 3 year follow-up, and 6-month change in myocardial perfusion (RTSS) measured quantitatively by gated SPECT myocardial perfusion imaging. Secondary endpoints include cardiovascular magnetic imaging resonance (CMR) to measure left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), left ventricular end-systolic diameter (LVEDV), and infarct size (baseline and six months). While 6 month and 12 month data have been collected, those data are subject to ongoing analysis, and results reported at this time are preliminary. There can be no assurance that further analysis may not reveal negative, or less promising, results. (NCT01495364)
Latest
news: * On March 16, 2015, NeoStem, a biopharmaceutical company developing novel cell based personalized medicine therapies, announced presentation of updated efficacy and safety results from the one-year follow-up for its Phase 2 PreSERVE study and additional analyses of certain functional tests at ACC.15, the American College of Cardiology’s 64th Annual Scientific Session and Expo, in San Diego, California. The one-year follow-up results are defined as all data accumulated until the last patient enrolled completed 12 month follow-up. Thus, the results actually represent data from patients with a median follow-up of 18 months.
The PreSERVE study is NeoStem’s clinical trial evaluating NBS10 which is being developed to treat damaged heart muscle following an acute myocardial infarction. One-year follow-up safety data collected thus far supports the trial’s 6 month results presented at the American Heart Association’s Scientific Sessions in November 2014. The ACC presentation contained updated safety and exploratory efficacy data and additional analyses conducted on left ventricular ejection fraction (LVEF) data. Clinical Endpoint Committee adjudication of major adverse cardiac events (MACE) was performed on the 6 month data reported previously and was not performed for new events (occurring between 6 and 12 months). At 12-month follow-up, no meaningful safety or tolerance differences were observed between treatment and control groups. In this updated analysis, no additional deaths were reported in the treatment or control groups beyond those previously reported in the six month analysis. In addition, in post hoc subset analyses based on the number of cells patients received, serious adverse event (SAE) frequency continues to show numerical improvement at all cell doses when compared to control.
No additional SPECT data were collected at one year follow-up. As an exploratory measure of efficacy, PreSERVE looked at reduction of infarct size at six months. Patients receiving 20 million cells or more experienced a decrease in infarct size of 41% vs 24% for patients in the control group.
Based on the one-year follow-up results, the company and its scientific advisors believe that the study results suggest that intracoronary administration of autologous CD34+ cells appears safe and well-tolerated. These results also indicate a signal for a mortality benefit; and a signal for reduction in the frequency of serious adverse events (SAEs) in higher dose groups. The company will now determine the next steps for the development of this program in the second half of 2015.
