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News Breaks
May 19, 2014
07:33 EDTNBSNeoStem awarded two European patents
NeoStem announced the expansion of its intellectual property protection surrounding its CD34 Cell Program in which it is developing therapeutics to address ischemia. AMR-001 is the company's most clinically advanced product candidate in its CD34 Cell Program and is being developed to treat damaged heat muscle following a heart attack. The European Patent Office has notified the company that it has granted patent numbers 1951864 and 2441461 for "Compositions and Methods of Vascular Injury Repair." These represent NeoStem's first granted European patents for its CD34 Cell Program and bring the Program's total worldwide patent coverage to 16 granted and allowed patents. NeoStem announced completion of enrollment in its Phase 2 PreSERVE AMI clinical trial in 4Q13, a randomized, double-blind placebo-controlled study testing AMR-001for the treatment of patients with left ventricular dysfunction following STEMI. Data read out is expected in 2H14 and the company expects to advance the technology into other clinical indications, such as chronic heart failure, traumatic brain injury and/or critical limb ischemia.
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March 25, 2015
07:16 EDTNBSPiper Jaffray and the Alliance for Regenerative Medicine co-host conference
3rd Annual Regenerative Medicine Investor Day is being held in New York on March 25 with webcasted company presentations to begin at 8 am; not all company presentations may be webcasted. Webcast Link
March 20, 2015
07:42 EDTNBSBioCentury to hold a conference
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March 16, 2015
06:05 EDTNBSNeoStem announces PreSERVE AMI clinical trial one-year follow up results
NeoStem announced the 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, or LVEF, data. Clinical Endpoint Committee adjudication of major adverse cardiac events, or MACE, was performed on the 6 month data reported previously and was not performed for new events. The next prescribed adjudication of MACE is currently planned at the end of patient follow-up. 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 frequency continues to show numerical improvement at all cell doses when compared to control.

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