PreSERVE AMI Phase 2 Trial will Continue as Planned
New York, September 17, 2013 — NeoStem, Inc. (NASDAQ:NBS) (“NeoStem” or the “Company”), a leader in the emerging cellular therapy market, today announced that, on September 13, 2013, the Data Safety Monitoring Board (“DSMB”) recommended continuing the PreSERVE AMI Phase 2 clinical trial following a third interim data and safety review. The PreSERVE trial of AMR-001 is a Phase 2, randomized, placebo controlled, double-blind study designed to treat 160 patients. AMR-001 is being evaluated for the preservation of heart function after a severe heart attack.
“We are grateful to the DSMB for their oversight of the study and pleased with the recommendation to continue enrollment,” said Douglas W. Losordo, MD, FACC, FAHA, Chief Medical Officer of NeoStem. “Despite advances in therapy for myocardial infarction (MI), post-MI left ventricular dysfunction is still a harbinger of an unfavorable long-term prognosis. AMR-001 has shown promise as a means of preserving heart muscle function after a heart attack and we are pleased to continue to work with our investigators across the U.S. to complete enrollment.”
Jonathan Sackner-Bernstein, MD, FACC, Vice President of Clinical Development and Regulatory Affairs of NeoStem, said, “The recommendation to continue with the trial is consistent with a wide range of publications that support the utility of autologous bone marrow derived CD34+ stem cells for treatment of this high risk population. The results from this double-blind, sham/placebo controlled study will define the path forward for this promising therapy.”
“We are very excited and encouraged by the enrollment progress of the PreSERVE Phase 2 clinical trial,” said Dr. Robin L. Smith, Chairman and CEO. “We are on track to complete patient enrollment for this trial in 2013 with data read out 6-8 months after the last patient is infused.”
About NeoStem, Inc.
NeoStem, Inc. (“NeoStem” or the “Company”) is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy products as well as operating a contract development and manufacturing organization providing services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue-generating service provider business provides the Company with capabilities for cost effective in-house product development and immediate revenue and cash flow generation.
For more information on NeoStem, please visit www.neostem.com.
Forward-Looking Statements for NeoStem, Inc.
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 research and development and clinical evaluation efforts as well as efforts towards commercialization of cellular therapies, including with respect to AMR-001, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the Company’s ability to successfully grow its 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 11, 2013 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.