NeoStem Announces the Addition of Jonathan Sackner-Bernstein, MD, Past FDA Official, as Vice President, Clinical Development and Regulatory Affairs


NEW YORK, April 11, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or "the Company"), a leader in the cell therapy industry, is pleased to announce that Jonathan Sackner-Bernstein, MD, FACC joined the firm as Vice President of Clinical Development and Regulatory Affairs.

He brings to the Company over 20 years of experience as a clinical cardiologist and medical researcher with leadership in healthcare management. Dr. Sackner-Bernstein will join the team to advance Amorcyte's PreSERVE AMI Phase 2 trial in addition to providing regulatory support for NeoStem's product pipeline.

"Jonathan's experience at the FDA and with Clinilabs, coupled with his experience as a cardiologist, make him a perfect choice to develop Amorcyte's AMR-001, in part by leveraging his relationships with clinical investigators and leaders in the cardiology community," said NeoStem's Chief Medical Officer, Dr. Andrew Pecora. "In terms of our Amorcyte product under development, a CD34+ cell for the preservation of heart muscle function after a large AMI, we continue to see data in the competitive landscape that supports our notion that this is the right strategy for success. As we are accruing our Phase 2 trial we are noting the incidence of low ejection fraction after a ST segment elevation myocardial infarction. Even with advances in the standard of care that have reduced the adverse events associated with an AMI, a meaningful percentage of patients are being found to have a left ventricular ejection fraction of less than 45 percent several days after an AMI. This is the group at risk for adverse events that AMR-001 is being tested on to determine if it will preserve heart muscle function to prevent adverse events."

From 2008 to 2011, Dr. Sackner-Bernstein served as Associate Center Director for Technology and Innovation at U.S. Food and Drug Administration's Center for Devices and Radiological Health. Previously, Dr. Sackner-Bernstein served as Chief Medical Officer at the clinical research organization, Clinilabs, where he established a Phase 1 research unit from 2006 to 2008 He also served as assistant professor of medicine at the Columbia University College of Physicians and Surgeons from 1993 to 2003. His academic accomplishments include contributions to medical therapy of heart failure and patients following heart attack as well as leadership in changing the paradigms of drug development in heart failure. Dr. Sackner-Bernstein also founded ExVivos, LLC, a privately-held company focusing on engineering tissues and organs from human cells for the development of drugs, vaccines and biological products. Dr. Sackner-Bernstein earned his B.S.E. from the Moore School of Electrical Engineering at the University of Pennsylvania and his M.D. from Jefferson Medical College. He completed training in Internal Medicine and Cardiology at Mount Sinai Hospital in New York. In addition, he holds Secret Clearance from the U.S. government.

Dr. Robin L. Smith, Chairman and CEO of NeoStem, said, "Jonathan's clinical experience as a cardiologist, and work at the FDA and Clinilabs, make him a perfect addition to the NeoStem senior management as we focus our resources to execute on our operational business plan which includes developing our most mature asset, AMR-001, enrolling patients in the Amorcyte Phase 2 trial and building our contract manufacturing business, Progenitor Cell Therapy (PCT). NeoStem has successfully repositioned the company through the acquisitions of both PCT and Amorcyte, effectively transforming our company to one that is focused on the development of novel cell based therapeutics and, as such, management is focused on execution to build investor confidence and bring value to our shareholders."

About NeoStem, Inc.

NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and has commenced enrollment for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.

For more information on NeoStem, please visit www.neostem.com.

Forward-Looking Statements

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 and medical strategy, including with respect to the development of AMR-001 and other cell therapies and its divestiture of its interest in Suzhou Erye Pharmaceutical Co., Ltd. about which no assurance can be given. 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 20, 2012 and in the Company's periodic filings with the Securities and Exchange Commission. 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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