NeoStem, Inc. ($NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced the expansion of its intellectual property protection surrounding its CD34 Cell Program in which it is developing therapeutics to address ischemia, the process that occurs when the supply of oxygenated blood in the body is restricted. AMR-001 is the Company's most clinically advanced product candidate in its CD34 Cell Program and is being developed to treat damaged heat muscle following a heart attack.
The European Patent Office has notified the Company that it has granted patent numbers 1951864 and 2441461 for "Compositions and Methods of Vascular Injury Repair." These represent NeoStem's first granted European patents for its CD34 Cell Program and bring the Program's total worldwide patent coverage to 16 granted and allowed patents.
"We are pleased to be building our international patent portfolio in the European Union and other geographic locations," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "We hope that laying this foundation now will support partnering activities once data from our Phase 2 PreSERVE clinical trial for AMR-001 becomes available later this year."
The continued expansion of the Company's intellectual property portfolio both domestically and internationally expands the commercial possibilities for its CD34 Cell Program, should any of these products in development receive regulatory approval. In the past year, NeoStem has announced expansion of its patent protection for its CD34 Cell Program in the U.S. and around the globe, including Japan, Canada, Russia, Malaysia, the Philippines, and now the European Union.
Heart attacks and cardiovascular disease are significant threats to public health in many countries, not just the U.S. If approved by the FDA and other worldwide regulatory agencies, AMR-001 could address significant unmet medical needs in the treatment of cardiovascular disease around the world.
It is estimated that each year cardiovascular disease causes over 1.9 million deaths in the European Union and costs its economy almost $270 billion. It has further been estimated that in Europe, 6.5 million patients suffer from chronic heart failure and this number is rising due to the aging of the population. A study published in The European Heart Journal (2010) found that the annual incidence of hospital admission for any AMI varied between 90–312 per 100,000 per year, with the incidence of ST segment elevation myocardial infarction ("STEMI") alone ranging from 44 to 142 per 100,000.
NeoStem announced completion of enrollment in its Phase 2 PreSERVE AMI clinical trial in Q4 2013, a randomized, double-blind placebo-controlled study testing AMR-001for the treatment of patients with left ventricular dysfunction following 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.
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
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.