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We at NeoStem, Inc. (NYSE MKT:NBS) believe that cell therapy has the potential to radically change the face of how diseases are treated, leading to longer and, more importantly, higher quality lives. NeoStem is proud of its role at the forefront of this paradigm shift underway in medicine toward cell therapy – a shift away from treating disease with drugs and toward treating disease with our own cells; a shift away from treating symptoms and toward cures for the illnesses that cause the most suffering; a shift away from chemical drug development and toward looking inside ourselves to understand and then amplify our body's natural repair mechanisms.
NeoStem is becoming a leading player in cell therapy by vertically integrating the collection, storage and processing of cellular material and by developing, manufacturing, distributing, and delivering cell therapy products. We are taking advantage of the growth in the cell therapy industry both for our clients and for our internal pipeline. Our proprietary product development efforts target unmet medical needs in conditions that include cardiovascular disease (myocardial infarction and congestive heart failure), immune disorders (type 1 diabetes, steroid resistant asthma, organ rejection) and tissue repair (wounds, osteoporosis, macular degeneration and other indications).
PreSERVE Phase 2 Clinical Trial
We are very excited and encouraged by our cardiovascular program, which is advancing nicely in the clinic and which, we believe, is built upon strong intellectual property. As of April 30
th, we have enrolled 108 patients into our AMR-001 Phase 2 PreSERVE clinical trial that treats patients who suffered a heart attack and we are on track to complete enrollment this year with data read out 6-8 months after the last patient is enrolled. We have shifted our expenditures to have a greater focus on investment in development of cell therapy products, spending $3.2 million on research and development in Q1 2013.
Amorcyte Intellectual Property Portfolio
AMR-001 now has the benefit of 4 granted U.S patents, 5 patent grants outside of the U.S. and 30 additional patents pending around the world. In brief, our granted U.S. patents are as follows:
U.S. Patent No. 7,794,705 covers a cell-based composition used to prevent deterioration of heart muscle post a heart attack. The composition contains a therapeutically effective amount of autologous mononuclear cells enriched for CD34 cells which further contain a subpopulation of biologically active CD34+/CXCR-4+ cells.
With the grant of U.S. Patent 8,088,370, the AMR-001 product's use was extended beyond heart attack to treatment for any vascular injury caused by vascular insufficiency.
Amorcyte's claims in U.S. Patent 8,343,485 similarly cover a cell-based therapy to repair a vascular injury caused by vascular insufficiency, but the product's CD34+ cell content limitation was greatly expanded in this patent to cover purities of almost any amount, and the product serum content was also expanded.
Amorcyte's most recently granted patent (U.S 8,425,899) covers AMR-001 for the treatment of progressive myocardial injury due to vascular insufficiency, including the disease progression that leads to heart failure, together with claims that cover freezing cells and using them in a treatment regimen that includes multiple doses over time.
We are beginning the process of expanding applications for AMR-001 into other ischemic conditions such as congestive heart failure and traumatic brain injury.