In the United States, heart disease costs about $204 billion annually and causes one-third of all deaths each year. Treatment options for most types of heart disease typically include a life-long medication regimen. Other options include implanted devices such as coronary stents, pacemakers, and cardio-defibrillators, and for some patients, heart transplantation may be indicated. However, for many of the estimated 83 million American adults who have some form of heart disease, the currently-available medical and surgical options are inadequate to address their condition.
Coronary heart disease, which is characterized by a buildup of plaque inside the coronary arteries, is the most common form of heart disease. Plaques are made up of fat, cholesterol, calcium, and other substances found in the blood. A plaque can eventually burst, tear or rupture, creating a “snag” where a blood clot forms and blocks blood flow in the artery, depriving part of the heart of oxygen and nutrients. This leads to a myocardial infarction (MI), the medical term for heart attack. If the flow of blood is not restored within a few minutes, heart muscle cells may die, causing permanent damage.
As the heart muscle begins to heal, a scar is formed that can diminish normal heart function. Patients who suffer an MI often continue to experience degeneration or weakening of their heart muscle, which can lead to heart failure and ultimately may shorten their lives.
Coronary heart disease afflicts approximately 15 million people in the U.S. and causes almost 50% of heart disease deaths in the United States. In 2004, coronary heart disease was responsible for 1.2 million hospital stays and was the most expensive condition to treat. Coronary heart disease is the primary cause of heart attack or MI, which strikes nearly 720,000 Americans a year often leading to repeated hospitalizations, a decrease in quality of life and premature death. In fact, more than seven million people in the U.S. have had a heart attack. Capricor is evaluating CAP-1002 in the Phase II ALLSTAR clinical trial to determine its efficacy in reversing damage caused by heart attack, which had been shown with autologous CDCs in the CADUCEUS trial.
Heart failure occurs when the heart is not able to properly pump blood to the rest of the body and fluid backs up into the lung and other internal organs and is a significant cause of morbidity and mortality. It affects about 5 million people and, according to recent estimates, costs between $70 and $126 billion annually in the United States. The number of U.S. adults with heart failure is expected to increase to 8 million people by 2030, a 46% increase. The disease progresses over a long period of time and can make everyday activities more difficult. In addition to unhealthy behaviors, diseases that cause damage to the heart – such as heart attack, diabetes, and high blood pressure – can increase the chances of getting heart failure. The heart tries to meet the body’s need for blood flow in several ways, but these temporary measures are not sustainable over time and eventually heart failure worsens until the heart is not able to keep up.
Among the diseases of the heart muscle that can eventually cause the heart’s function to fail, dilated cardiomyopathy is common. This is characterized by the enlargement and weakening of the heart’s left ventricle, its main pumping chamber. The enlarged, or dilated, left ventricle becomes weakened and cannot pump blood to the body with as much force as a healthy heart.
Dilated cardiomyopathy may result from a variety of events or conditions, including coronary heart disease and heart attack, as well as viral infections. While many people with dilated cardiomyopathy have minor or no symptoms, other people develop symptoms that may progress and worsen as heart function worsens.
In October 2016, Capricor reported results from its DYNAMIC clinical trial in which broad and sustained improvements were observed out to one year in advanced heart failure patients who were treated with CAP-1002.