NEW YORK, June 17, 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 a patent allowance in Canada. This patent is in the family titled "Compositions and Methods of Vascular Injury Repair" and protects a chemotactic stem cell product enriched for CD34+ cells that treats injury from acute myocardial infarction ("AMI").
"This incremental patent will bring AMR-001's total worldwide patent coverage to ten patents," said Dr. Andrew L. Pecora, Chief Medical Officer of NeoStem. "If our trial results warrant regulatory approval, after launch in the U.S., Canadian expansion of AMR-001 sales would be a logical step and creates the potential to access a nearby market where heart attack and cardiovascular disease are significant threats to public health."
According to reports, cardiovascular disease is a significant problem in Canada. The population of Canada is approximately 35.5 million with an estimated 70,000 heart attacks occurring each year. Heart disease accounts for over 20% of deaths in Canada.
NeoStem's AMR-001 is a cell therapy in development for the treatment of cardiovascular disease. The Company is on track to complete enrollment this year 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.
"Canada is yet another significant possible market for AMR-001. With a strong patent portfolio already under our belts, we look forward to 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.
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.
CONTACT: NeoStem Dr. Robin L. Smith Chairman and CEO Phone: +1-212-584-4174 Email: firstname.lastname@example.org