NEW YORK, Sept. 10, 2012 (GLOBE NEWSWIRE) -- Amorcyte, LLC, a subsidiary of NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), today announced a significant expansion in its claims granted to protect the use of CD34+ cells, acquired from blood or bone marrow, to impart a therapeutic benefit to tissue sustaining an ischemic injury. "We received notification that claims granted in the United States have now been granted by the Japanese Patent Office. Additionally, we received recently a Notice of Allowance from the U.S. Patent Office that further expands the scope and protection of our existing CD34+ product patents here in the U.S.," said Andrew Pecora, M.D. FACP CPE, Chief Medical Officer of NeoStem. "Collectively, our newly granted and issued claims will support commercialization of AMR-001 globally, if approved, and afford the potential to broaden the scope of AMR-001's development to include repair of ischemic tissue anywhere in the body."
The Japanese Patent Office granted Amorcyte's patent entitled "Compositions and Methods of Vascular Injury Repair." Japan represents another major market to grant patent protection for Amorcyte's product, AMR-001, a CD34+ CXCR4+ cell therapy developed to preserve heart muscle and prevent major adverse cardiac events following acute myocardial infarction (AMI). Related patent applications are being pursued in other global markets. AMR-001 is currently being evaluated in a U.S. Phase 2 clinical trial (PreSERVE AMI) intended to preserve cardiac function and prevent adverse clinical events after a large myocardial infarction.
"The option to pursue our AMR-001 product for the Japanese cardiovascular market with the backing of strong domestic intellectual property protection represents a significant opportunity for NeoStem," said Robin L. Smith, M.D., Chairman and CEO of NeoStem. "Heart disease is the second most prevalent cause of mortality in Japan, according to a meta-analysis published by the American Heart Association. A long-term study (MIYAGI – AMI Registry Study) showed that the incidence of AMI in Japan has significantly increased over the last thirty years, from 7.4 per 100,000 persons/year in 1979 to 27.0 in 2008. Furthermore, Japan's large population of 127 million, together with its wealth (24th out of all nations in terms of per capita GDP), makes it a market that can adopt novel therapeutics like AMR-001 that can potentially extend and improve quality of life as a standard of care."
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. 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 robust intellectual property estate, we believe we are well positioned to succeed.
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 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.