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Dear NeoStem Shareholders,
Regenerative medicine is the catalyst to radically change the practice of medicine from that of chronic treatment to that of cure. The shift is away from treating the symptoms with synthetic drugs towards treating the underlying cause of disease by using one's own natural cells. Cell therapy holds the promise of prolonging and, most importantly, enhancing quality of life. This is the future of medicine and it is our singular mission to lead the way.
NeoStem (NYSE MKT:NBS) is an integrative force in the cell therapy industry. By vertically integrating the collection, storage and processing of cellular material with the development, manufacture, distribution, and delivery of cell therapy products, we are positioned to capitalize on the emerging cell therapy industry. We provide such contract development and manufacturing services for clients and we also have a proprietary pipeline of cell therapy products in development designed to address unmet medical needs, including cardiovascular disease (MI and CHF), immune disorders (type 1 diabetes, steroid resistant asthma, organ rejection) and tissue repair (wounds, osteoporosis, macular degeneration, etc). Our most advanced cardiovascular asset, AMR-001, is very exciting (
see video at
www.neostem.com/videos.html ) and is built upon a very strong intellectual property portfolio.
PreSERVE Phase 2 Clinical Trial –
Presently, with thirty two (32) clinical trial sites having enrolled over ninety (90) patients, Amorcyte has enrolled over half of the scheduled patients in its PreSERVE-AMI Phase 2 clinical trial. We are also pleased to report that an additional twenty (20) clinical trial sites are in the process of coming on board. In the PreSERVE trial, stem cells are collected from the patient's bone marrow and enriched, not expanded, to increase potency. These cells are stabilized and have a 72-hour shelf life. The cells are infused via the infarct-related artery 5 to 11 days following a stent placement – the optimal time frame to prevent adverse ventricular remodeling. There, they are being tested to save damaged tissue that would otherwise die within days or weeks, consequently preserving cardiac function and potentially preventing clinical adverse events by releasing chemicals and proteins that grow blood vessels through a process called angiogenesis. We received six and twelve month evaluations of our trial by the Data Safety Monitoring Board confirming that there are no safety signals that would preclude the trial from continuing as planned and expect to complete enrollment in 2013 with data read out 6-8 months after the last patient is enrolled.