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NEW YORK, May 27, 2014 (GLOBE NEWSWIRE) -- 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 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.