Dd&d addressing the unmet needs of ami patients - dr. pecora 01.31.12

Addressing the Unmet Needs of AMI PatientsAndrew Pecora, MD, FACP, Chief Medical Officer; NeoStem, Inc., New York CityDrug Discovery & Development - January 31, 2012In the United States and other developed nations, heart disease kills more peopleevery year than cancer and costs nearly twice as much to treat. 1 For these patients,adult stem cell biology signifies a new medical frontier.Coronary heart disease (CHD) is the leading cause of death in the United States forboth men and women.2 CHD is caused by a buildup of plaque in the coronary arteriesleading to the heart. This buildup causes the arteries to narrow and, as a result,myocardial ischemia—a restriction in blood supply to the heart—can occur. Theinterruption of blood supply to a part of the heart can result in myocardial infarction(MI) or acute myocardial infarction (AMI), commonly known as a heart attack. 3Significant advances have been made globally in the prevention and early treatmentof myocardial ischemia and infarction, reducing morbidity, mortality and cost.Despite these advances, 160,000 patients in the United States experience AMIs thatplace them at risk for cardiomyocyte dysfunction leading to heart failure and otheradverse cardiac-related events, including death.4There is an urgent need for novel therapeutic options for the prevention and earlytreatment of myocardial ischemia and infarction. Adult stem cell therapy has thepotential to limit or prevent the adverse consequences of a large AMI. If confirmed tobe safe and effective, cell therapy may revolutionize the approach to cardiovasculardisease.In some clinical studies, patients who received coronary artery injections of adultstem cells derived from their own bone marrow after a myocardial infarction showedimprovements in left ventricular function not seen in patients given a placebo. Thelarger the initial infarct size, the greater the effect of the infusion. There seems to bea safety advantage of autologous cells over allogeneic cells; it also appears thatautologous transplanted cells remain in the heart and potentially continue to workyears later, as demonstrated in preclinical animal experiments.Clinical trials using adult stem cell infusion as a treatment approach to AMI areongoing. Successes in pilot studies warrant large-scale longitudinal studies to examinethe potential effects of progenitor-cell administration on morbidity and mortality.

One example of an adult stem cell-based therapeutic application in the treatment ofAMI is AMR–001. AMR-001, manufactured by Amorcyte, Inc., is an autologous, bonemarrow-derived cell therapy designed to treat AMI patients with their own stem cells.In a Phase 1 trial, AMR–001 showed a dose–related significant improvement inperfusion. The study results demonstrated that patients receiving 10 million and 15million cells showed significant improvement in resting perfusion rates at six monthsas compared to patients receiving 5 million cells and control. The data also showedthat patients receiving 10 million or more cells showed a trend towards improvementin ejection fraction, the percentage of blood pumped out of a ventricle with eachheartbeat, end systolic volume, infarct size and tissue death due to loss of adequateblood supply at six month follow–up. No study–related significant adverse events werereported. Having completed the Phase 1 trial with promising results, AMR-001 enteredits Phase 2 clinical trial in early 2012.Intracoronary infusions of progenitor cells have shown preliminary successes inpreventing post-MI heart failure in clinical trials.5 Larger trials will be needed todetermine if past successes translate into reductions in clinical end points. If later-phase studies are successful, it would open up a whole new way of treating heartdisease. Investigation into the use of adult stem cells in the treatment of AMI mayprovide a promising future for regenerative therapeutics in the treatment ofprogressive cardiomyocyte dysfunction and in addressing one of the leading causes ofdeath globally.About the AuthorDr. Pecora is the chief medical officer at NeoStem, Inc., a biopharmaceuticalcompany engaged in regenerative science and the therapeutic development of cell-based therapies. He is the former chairman and chief executive officer of ProgenitorCell Therapy.References1. American Diabetes Association. Economic costs of diabetes in the U.S. in 2002.Diabetes Care. 26:917–932, 2003. 2. Feero WG, et al. Genomics of Cardiovascular Disease. N Engl J Med. 2011;365:2098-2109. 3. National Heart, Lung, and Blood Institute. NHLBI What Is Coronary Heart Disease?National Institute of Health, 2011. Available athttp://www.nhlbi.nih.gov/health/health-topics/topics/cad/. Accessed January 27,2012. 4. Amorcyte: About Amorcyte. http://www.amorcyte.com/about.htm. AccessedJanuary 27, 2012.

5. Tongers J, et al. Stem and progenitor cell-based therapy in ischaemic heartdisease: promise, uncertainties, and challenges. Eur Heart J. 2011; 32(10):1197. © 2007 Advantage Business Mediahttp://www.dddmag.com/article-Addressing-the-Unmet-Needs-of-AMI-Patients-13112.aspx

Dd&d addressing the unmet needs of ami patients - dr. pecora 01.31.12

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