NeoStem, Inc. ($NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced the expansion of intellectual property protection surrounding its CD34 Cell Program. That program is developing therapeutics to address ischemia, the process that occurs when the supply of oxygenated blood in the body is restricted. The recently granted U.S. patents relate to AMR-001, the Company's most clinically advanced product candidate in its CD34 Cell Program, which is designed to treat damaged heart muscle following acute myocardial infarction (AMI or heart attack).
United States patents 8,637,005 and 8,709,403 are entitled "Compositions and Methods of Vascular Injury Repair" and serve to further expand the range of serum concentrations used to deliver CD34 cells from claims of previously granted patents. These patents bring the total number of granted and allowed patents for the Company's CD34 cell program to 16.
Heart attacks and cardiovascular disease are a significant physical and economic burden on society. If approved by the FDA and other worldwide regulatory agencies, AMR-001 for AMI patients could address significant unmet medical need in the treatment of cardiovascular disease around the world. AMI patients are at significant risk of downstream adverse events, including chronic heart failure, re-current AMI, significant arrhythmias, premature death or acute coronary syndrome. A statistical report from Agency for Healthcare Research and Quality (2011) surveyed the most expensive hospitalization conditions by payer and lists AMI as the sixth most expensive condition treated in U.S. hospitals, with a national hospital bill of more than $37 billion annually.
"As we continue to develop our therapeutic candidates, advancement in our intellectual property profile, in the U.S. and globally, expands the potential for partnership discussions," said Dr. Robin Smith, Chairman and CEO of NeoStem.
NeoStem is increasing its patent portfolio for its CD34 Cell Program both domestically and internationally, including recent patent grants in the European Union, Japan, Canada, Russia, Malaysia, and the Philippines. In Q4 2013 the Company announced completion of enrollment in its Phase 2 PreSERVE AMI clinical trial, a randomized, double-blind placebo-controlled study testing AMR-001for the treatment of patients with left ventricular dysfunction following ST segment elevation myocardial infarction ("STEMI"). Data read-out is expected in 2H 2014 and the Company expects to advance the technology into other clinical indications such as chronic heart failure, traumatic brain injury and/or critical limb ischemia.
About NeoStem's CD34 Cell Program
NeoStem is developing therapies to address ischemia through its CD34 Cell Program. Ischemia occurs when the supply of oxygenated blood in the body is restricted. The Company's therapeutics seek to reverse this restriction through the development and formation of new blood vessels. The Program's lead product candidate is AMR-001, a chemotactic hematopoietic stem cell product comprised of autologous bone marrow derived CD34/CXCR4 cells selected to treat damaged heart muscle following AMI (heart attack). AMR-001 works by increasing microvascular blood flow in the heart muscle via the development and formation of new blood vessels, thereby reversing the restriction of blood supply caused by a heart attack and rescuing tissue from eventual cell death.
About NeoStem
NeoStem is a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation. 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 strategy, the Company's ability to develop and grow its business, the successful development of cellular therapies with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Targeted Immunotherapy Program, CD34 Cell Program (including whether or not the Company's Phase 2 PreSERVE clinical trial will generate positive data), T Regulatory Cell Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the performance and planned expansion of the Company's 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 ("SEC") on March 13, 2014, the Company's Current Report on Form 8-K filed with the SEC on May 8, 2014 and in the Company's other 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.
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