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NeoStem Signs Definitive Merger Agreement to Acquire Amorcyte in Equity Transaction

NEW YORK, July 14, 2011 /PRNewswire/ -- NeoStem, Inc. (NYSE Amex: NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company, announced the signing of a definitive merger agreement whereby NeoStem will acquire Amorcyte, Inc. ("Amorcyte"),  a  development stage cell therapy company focusing on novel treatments for cardiovascular disease. Amorcyte's lead product candidate, AMR-001, is ready to initiate a Phase II study for the  treatment of acute myocardial infarction (AMI).

Of the approximately 800,000 Americans who suffer an AMI each year, twenty percent or 160,000 patients remain at risk to subsequently experience progressive deterioration in heart muscle function and as a consequence, an increase in major adverse cardiac events (MACE). AMR-001 targets treatment of this unmet medical need. Based on a comprehensive pre-clinical program which identified a mechanism of action with a highly purified homogeneous cell population, a Phase I study was completed. Results of the clinical study identified a therapeutic dose (biological threshold dose) that was associated with a significant improvement in perfusion (p=0.01) in the peri-infarct zone. The Phase I clinical trial results for AMR-001 suggest that this cell based therapy improves microvascular density (perfusion) and rescues at-risk cardiomyocytes (cardiac muscle cells) from hibernation and apoptosis (cell death).  The logical implications of those results, and the subject of future studies, will explore the potential of AMR-001 to preserve heart muscle function and consequently improve both quality-of-life and longevity by reducing the incidence and severity of MACE.

AMR-001 is an autologous, bone marrow derived, pharmaceutical grade cell-based product that uses a cell population enriched for CD34+CXCR4+ cells. Studies have shown that these cells act as a natural repair mechanism, releasing from bone marrow and traveling to the damaged region of the heart following an AMI. Treatment with AMR-001 involves infusion of an active population of these cells directly into a patient’s heart via an intra-coronary catheter six to eleven days after an AMI (i.e., after the “hot (inflammatory) phase”) and as such complements the body’s natural  rescue mechanism for those cells that face hypoxic stress (i.e., oxygen deprivation) as a result of an increased workload.

Unlike competitor cell therapy products being tested for cardiac repair post-AMI, NeoStem believes AMR-001 stands alone in its ability to claim all of the following attributes:

  • a confirmed mechanism of action
  • a cGMP (current good manufacturing practices) facility
  • an established dose that exceeds the threshold of biological activity
  • use of autologous cells that have no risk of rejection and are capable of integrating and providing local support, potentially for a prolonged period of time as demonstrated in pre-clinical animal experiments
  • cells that are not expanded, thereby eliminating the potential concerns associated with such expansion
  • composition of matter, methods and processes patents with long remaining life

  • To the Company's knowledge, this is the first stem cell trial in AMI ever conducted that prospectively established a significant relationship between dose and effect. NeoStem intends to enter the clinic for the start of the Phase II trial for AMR-001 no later than the  first quarter of 2012 and to commence a Phase I study in congestive heart failure in 2012.  The enrollment of this Phase II trial is estimated to complete within 12 months from start with data read-out 6 months after the last patient is treated.

    The definitive merger agreement provides for the issuance of an aggregate of 6,821,283 shares of NeoStem common stock and warrants to purchase an aggregate of 1,881,008 shares of NeoStem common stock. An additional 4,092,768 shares of NeoStem stock will vest upon achievement of specified AMR-001 milestones. Amorcyte shareholders will receive additional consideration in the form of an earn out upon commercialization.

    Holders of greater than 50% of Amorcyte's shares have agreed to vote in favor of the merger.  The closing of the merger is subject to various conditions, including the approval by NeoStem and Amorcyte stockholders of the issuance of NeoStem's securities in the merger.

    Dr. Robin L. Smith, CEO of NeoStem said, "We are excited to have reached this agreement with Amorcyte and to be in position to acquire this asset which is on the verge of commencing Phase II trials and which has a strong IP position that includes key issued patents for both composition of matter  and method of use. We anticipate a seamless integration with our operations as PCT, our wholly-owned subsidiary, manufactured the cells for the AMR-001 Phase I clinical trial and has already been selected to manufacture AMR-001 for the Phase II trial."

    "We are excited about the Phase 1 trial results and look forward to moving Amorcyte's lead product AMR-001 forward and toward commercialization through NeoStem," said Dr. Andrew Pecora, Chief Medical Officer of PCT and Chief Scientific Officer of Amorcyte. "Through NeoStem's preclinical VSEL platform, the Phase I-ready autoimmune disease product candidates of its Athelos subsidiary, and now through AMR-001, NeoStem seeks to fulfill the promise that an individual's own cells hold the potential to both heal and transform the way medicine is delivered."

    About NeoStem, Inc.NeoStem, Inc. is engaged in the development and manufacturing of cell-based therapies in the U.S.  Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.  The acquisition of PCT gives NeoStem not only access to a world class contract manufacturing cell therapy company but provides a platform and expertise around the evaluation, development and regulatory requirements to develop autologous, allogeneic, immunomodulatory and vaccine-based therapeutics. NeoStem also holds the worldwide exclusive license to VSEL(TM) Technology, which uses very small embryonic-like stem cells, shown to have several physical characteristics that are generally found in embryonic stem cells, and is pursuing the licensing of other technologies for therapeutic use. NeoStem owns 80% of Athelos Corporation, a company developing a T-cell therapeutic with potential in a range of auto-immune conditions such as graft versus host disease, asthma and diabetes. Furthermore, NeoStem is building its Chinese presence by establishing an operations lab for cell-based manufacturing in Beijing as well as commercializing cellular therapies in China through the establishment of a network of hospitals.  NeoStem also owns a majority-interest in Suzhou Erye Pharmaceutical Company Limited, a world class manufacturing and distribution operation of generic antibiotics in China.

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    About AmorcyteAmorcyte is a privately held biotechnology company developing cell therapy products to treat cardiovascular disease. Its lead product, AMR–001, for the prevention of major adverse cardiac events following acute myocardial infarction (AMI), has completed Phase I clinical trials demonstrating feasibility, safety and biologic activity at a threshold dose. This is the first stem cell trial in AMI ever conducted that has prospectively established a significant relationship between dose and effect. Amorcyte has partnered with Progenitor Cell Therapy, a leading provider of clinical, manufacturing and other services for the cell therapy industry and a fully-owned subsidiary of NeoStem, Inc., to provide Amorcyte with a pharmaceutical grade cGMP manufactured product that can be distributed commercially. Amorcyte was founded by Andrew Pecora, M.D., Vice President of The John Theurer Cancer Center at Hackensack University Cancer Center, with initial investment by Novitas Capital and Colt Ventures.

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    Forward-Looking StatementsThis 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, and the potential development of AMR-001 and other cell therapies, about which no assurances 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 April 6, 2011 and its Form 8-K filed on July 14, 2011, as well as other periodic filings made 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.NeoStem, Inc.Robin Smith, CEO Phone: +1 (212) 584-4174E-mail:

    SOURCE NeoStem, Inc.
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