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June 16, 2014
07:41 EDTNBSNeoStem presents results for Phase 1 study of autologous Treg immunotherapy
NeoStem announced the presentation of the results of an open-label dose escalation Phase 1 clinical study of autologous T regulatory cell, or Treg, immunotherapy for type 1 diabetes mellitus, or T1DM, indicating safety and tolerability following administration. As reported by UCSF, in the study, 14 patients between 18 and 45 years of age with a mean duration of disease of 10 months all of whom retained a baseline level of insulin production, received a single infusion of autologous Tregs expanded ~500-fold. The infusions were well tolerated; the majority of adverse events reported were mild. Infused Tregs peaked in circulation 3-7 days after infusion and were detectable at greater than 6 months. The average levels of stimulated C-peptide, an indicator of pancreatic islets beta cell function, for some patients remained stable from baseline for as long as 2 years post treatment. These data suggest that the treatment was safe and did not adversely affect residual beta cell function. The Tregs were observed to be highly functional and long lived in treated individuals. While the U.S. Phase 1 study was designed to evaluate safety and tolerability in adults who have suffered T1DM for various durations, supportive evidence of the utility of Tregs for T1DM in humans was provided by a study of pediatric patients with new onset T1DM. After 12 months of follow-up, about 66 percent of children treated were in remission, compared to only 20 percent of concurrent controls, and two Treg treated children achieved complete insulin independence, while none of the control children achieved this endpoint. Initiation of Phase 2 study is expected for Q3.
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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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