NEW YORK, May 16, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, today announced the geographic expansion of intellectual property protection around its lead product candidate, AMR-001, with the notice of patent grant in Malaysia (MY-147516-A) and notice of recommendation for patent allowance in the Philippines (1-2008-501074). These patents are in the family of U.S. patent number 7,794,705 titled "Compositions and Methods of Vascular Injury Repair" and protect a chemotactic stem cell product enriched for CD34+ cells that treats injury from acute myocardial infarction ("AMI").
Additionally, NeoStem has been granted a second South African patent (ZA 2011/04059) titled "Infarct Area Perfusion-Improving Compositions and Methods of Vascular Injury Repair."
"These incremental patents will bring AMR-001's total worldwide patent coverage to nine patents," said Dr. Andrew L. Pecora, Chief Medical Officer of NeoStem. "The Asian and African geographic expansion of Amorcyte's patent protection, which also includes Japan as previously announced, creates the potential to access markets where heart attack and cardiovascular disease are significant threats to public health."
According to reports, cardiovascular disease is a significant problem in the Philippines, South Africa and Malaysia. The populations in each of these countries are 95 million, 51 million, and 29 million respectively.
- Heart disease is the number one killer in both Malaysia and the Philippines, accounting for 1 out of every 5 deaths in the Philippines.
- The prevalence of risk factors for heart disease is significant in Malaysia, with physical inactivity at 60.1%, smoking at 25.5%, and hypertension at 25.7%.
- In South Africa, approximately 130 heart attacks occur every day, or almost 50,000 per year.
- Premature deaths from cardiovascular disease in South Africa are projected to increase by 41% by 2030 in people from 35-64 years old.
NeoStem's AMR-001 is a cell therapy in development for the treatment of cardiovascular disease. The Company is on track to complete enrollment in 2013 of patients in the Phase 2 PreSERVE AMR-001 double-blinded clinical trial to investigate AMR-001's safety and efficacy in preserving heart function after a heart attack in a particular type of post-AMI patient. NeoStem expects to have the first data readout available six to eight months after the last patient is enrolled. If approved by the U.S. Food and Drug Administration ("FDA") and/or other worldwide regulatory agencies, AMR-001 would address a significant unmet medical need in the treatment of AMI and position the Company to capture a meaningful share of the worldwide AMI market. "These notices are testament to the strength of the AMR-001 product candidate and we expect to see further expansion of our intellectual property in the coming years," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.
About NeoStem, Inc.
NeoStem, Inc. ("NeoStem" or the "Company") is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy products as well as operating a contract development and manufacturing organization ("CDMO") providing services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue-generating service provider business provides the Company with capabilities for cost effective in-house product development and immediate revenue and cash flow generation.
For more information, please visit: 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, including with respect to the Company's research and development and clinical evaluation efforts for cellular therapies, including with respect to AMR-001, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the Company's ability to successfully grow its 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 on March 11, 2013 and in the Company's 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.