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March 17, 2014
07:40 EDTNBSNeoStem reports fourth data safety monitoring board review of PreSERVE AMI trial
NeoStem announced that, on March 11, the Data Safety Monitoring Board, or DSMB, recommended continuing the PreSERVE AMI Phase 2 clinical trial following a fourth interim data and safety review. The PreSERVE trial of AMR-001 is a Phase 2, randomized, placebo controlled, double-blind study designed to enroll 160 patients. AMR-001 is being evaluated for the preservation of heart function after a severe heart attack. Full enrollment has been completed for the trial and data will be available in the second half of 2014. AMI, significantly reduces the cumulative incidence of major adverse clinical cardiac events, including death, heart failure and recurrent cardiac ischemia1. These data further support the ongoing development of NeoStem's lead product candidate, AMR-001, an autologous bone marrow derived CXCR4 expressing cell that was shown in a Phase 1 trial to induce new blood vessel growth and preserve heart muscle function after a severe heart attack.
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January 20, 2015
07:33 EDTNBSNeoStem receives drug manufacture license for Irvine, CA facility
NeoStem announced that the State of California's Department of Public Health, Food and Drug Branch has completed its review of NeoStem's manufacturing and control processes at its Irvine, California cGMP facility for the production of eltrapuldencel-T and has issued NeoStem a manufacturing license permitting NeoStem to manufacture drugs from this facility, including the manufacture of eltrapuldencel-T for clinical trial use. Eltrapuldencel-T is the company's patient-specific targeted cancer immunotherapy under investigation for the treatment of Stage IV or recurrent Stage III metastatic melanoma.

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