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May 29, 2014
07:35 EDTNBSNeoStem presents five-year survival data for autologous melanoma Immunotherapy
NeoStem announced results of a pooled analysis indicating that Melapuldencel-T, an investigational patient-specific immunotherapy for metastatic melanoma, may increase survival rates significantly for patients at the most advanced stages of the disease. The findings will be presented on Sunday, June 1 in a poster by Robert O. Dillman, MD, study author and Vice-President, NeoStem Oncology, at the 50th Annual Meeting of the American Society of Clinical Oncology, or ASCO. The analysis to be presented at ASCO includes a subset of pooled data from three melanoma clinical trials, conducted successively from 1990-2011. Two of these trials, one of which was controlled and one of which was not, studied Melapuldencel-T. The new pooled analysis indicates significantly better five-year overall survival rates in patients treated with Melapuldencel-T than those treated with the comparator therapy for the subset of patients who still had evidence of disease after prior treatment with one or more standard therapies. "This subset analysis lends further support to the view that tumor-initiating cells are viable targets for therapeutic interventions like Melapuldencel-T, aiming for better overall survival, even for patients in the most advanced stages of malignant melanoma. In addition, the product may have significant safety and tolerability advantages over existing therapies," said Dr. Dillman. Chief Medical Officer Douglas Losordo, said, "NeoStem is excited to continue investigating this promising therapy in a large-scale Phase 3 study beginning this year." Melapuldencel-T was developed by California Stem Cell, Inc., which was acquired by NeoStem in May. NeoStem is initiating a Phase 3 study of Melapuldencel-T later this year under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration, and the therapy has been granted fast-track designation by the agency as well.
News For NBS From The Last 14 Days
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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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