New York, January 6, 2014 — NeoStem, Inc. (NASDAQ:NBS) (“NeoStem” or the “Company”), a leader in the emerging cellular therapy industry, today announced the expansion of intellectual property protection surrounding the Company’s lead product candidate, AMR-001, a chemotactic stem cell product enriched for CD34+ cells that treats injury from vascular insufficiency.
The U.S. Patent and Trademark Office has issued a notice of allowance for what is the sixth granted or allowed U.S. patent for AMR-001. Additionally, the European Patent Office has notified the Company of its intention to grant two patents for AMR-001. These represent NeoStem’s first European patent allowances for AMR-001 and bring AMR-001’s total worldwide patent coverage to 16 granted and allowed patents.
“With patient enrollment for the Phase 2 PreSERVE AMI trial for AMR-001 complete and data expected in Q3 2014, we hope to proceed to a Phase 3 trial for acute myocardial infarction (“AMI”) and are planning to enter into other indications, such as congestive heart failure and traumatic brain injury. The continued expansion of our intellectual property portfolio both domestically and internationally expands the commercial possibilities for AMR-001, should it receive regulatory approval,” said Dr. Robin L. Smith, Chairman and CEO of NeoStem.
“Since the inception of the AMR-001 program, NeoStem has been granted or allowed patents in many geographies beyond the U.S., including Japan, Canada, Russia, Malaysia, the Philippines, and now the European Union,” said Dr. Andrew L. Pecora, Chief Visionary Officer of NeoStem. “The addition of protection in Europe creates the potential to access a market where heart attack and cardiovascular disease are significant threats to public health.”
If approved by the U.S. Food and Drug Administration and other worldwide regulatory agencies, AMR-001 could address significant unmet medical needs around the world in the treatment of cardiovascular disease. 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 ageing of the population. A recent 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 recently 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 acute STEMI.