StemCell Therapy

NEW YORK, Oct. 10, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), an emerging leader in the fast growing cell therapy market, announced today that a new article published by the International Scholarly Research Network provides further evidence that AMR-001, NeoStem's lead product candidate through its Amorcyte subsidiary, appears capable of preserving heart muscle function following a large myocardial infarction. Amorcyte demonstrated in its Phase 1 trial that AMR-001 preserved heart muscle function when a therapeutic dose of cells was administered. No patient experienced a deterioration in heart muscle function who received 10 million cells or more whereas 30 to 40 percent of patients not receiving a therapeutic dose did. The new study shows that cardiac muscle function sparing effects are evident even earlier after treatment than previously shown.

The article titled "Assessment of myocardial contractile function using global and segmental circumferential strain following intracoronary stem cell infusion after myocardial infarction: MRI Feature Tracking Feasibility Study" by Sabha Bhatti, MD, et al. appears in ISRN Radiology Volume 2013, Article ID 371028 and is published online at http://www.isrn.com/journals/radiology/2013/371028. The publication by Dr. Bhatti and colleagues, including Dr. Andrew Pecora, Chief Medical Officer of NeoStem, supports the finding that AMR-001 preserves heart function. Previously, Amorcyte, a NeoStem subsidiary, showed that six months after STEMI AMR-001 improved blood flow to the heart and preserved heart muscle. By using cardiac magnetic resonance imaging, specifically measuring circumferential strain of the left ventricle, the authors show that AMR-001's effects are evident by three months after STEMI.

AMR-001's angiogenic and anti-apoptotic mechanisms of action indicate that preservation of heart muscle function should start within weeks and be evident in fewer than 6 months. This publication, based on blinded analysis of Amorcyte's Phase 1 data, confirms the expected time course for AMR-001's mechanism of action. In the context of previously published results, these effects are durable.

Amorcyte is developing AMR-001, a cell therapy for the treatment of cardiovascular disease, and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving cardiac function and preventing adverse clinical events after a large myocardial infarction.

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, as mentioned above, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

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 or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its CDMO business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to (i) the Company's ability to manage its business despite operating losses and cash outflows, (ii) its ability to obtain sufficient capital or strategic business arrangement to fund its operations, including the clinical trials for AMR-001, (iii) successful results of the Company's clinical trials of AMR-001 and other cellular therapeutic products that may be pursued, (iv) demand for and market acceptance of AMR-001 or other cell therapies if clinical trials are successful and the Company is permitted to market such products, (v) establishment of a large global market for cellular-based products, (vi) the impact of competitive products and pricing, (vii) the impact of future scientific and medical developments, (viii) the Company's ability to obtain appropriate governmental licenses and approvals and, in general, future actions of regulatory bodies, including the FDA and foreign counterparts, (ix) reimbursement and rebate policies of government agencies and private payers, (x) the Company's ability to protect its intellectual property, (xi) the company's ability to successfully divest its interest in Erye, and (xii) matters described under the "Risk Factors" 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 other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

Read more:
NeoStem Announces New Publication That Supports Positive Results of AMR-001 for Treatment of AMI

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