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NEW YORK, March 17, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced that, on March 11, 2014, the Data Safety Monitoring Board ("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.
Dr. Andreas Zeiher, an international expert in the development of cell based therapy for acute myocardial infarction (AMI) and principal investigator of a study published last month in the
European Heart Journal, demonstrated that administration of autologous bone marrow derived cells expressing the CXCR4 receptor, five to ten days after an AMI, significantly reduces the cumulative incidence of major adverse clinical cardiac events, including death, heart failure and recurrent cardiac ischemia
1. 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.
"We are grateful to the DSMB for their oversight of the study and pleased that the continued patient follow-up has yielded no safety concerns," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "We are also encouraged by Dr. Zeiher's recent study results which provide further support that the ability of AMR-001 to induce blood vessel growth and preserve heart muscle function will lead to significantly fewer adverse clinical cardiac events."
1. Assmus, B., et al. (2014). Long-term clinical outcome after intracoronary application of bone marrow-derived mononuclear cells for acute myocardial infarction: migratory capacity of administered cells determines event-free survival.
European heart journal, epub ahead of print.
About NeoStem, Inc.
NeoStem is a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's ability to develop and grow its business, the successful development of cellular therapies, including with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's CD34 Cell Program and our T-Regulatory Cell Program and other cell therapies, including with respect to AMR-001 for AMI, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the performance and planned expansion of the Company's contract development and manufacturing business. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2014 and in the Company's periodic filings with the SEC. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
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