Emphysema is a condition in which there is over-inflation of alveoli or air sacs. It is known from scientific research that the normal lung has a remarkable balance between two classes of chemicals with opposing actions. The lung also has a system of elastic fibers. The fibers allow the lungs to expand and contract. When the chemical balance is altered, the lungs lose the ability to protect themselves against the destruction of these elastic fibers. This over-inflation results from a breakdown of the walls of the alveoli, which causes a decrease in respiratory function and often, breathlessness. Early symptoms or emphysema include shortness of breath and coughing.
There are a number of reasons this chemical imbalance occurs. Smoking is responsible for 82% of chronic lung disease, including emphysema. Exposure to air pollution is another suspected cause. Irritating fumes and dusts on the job also are thought to be a factor. A small number of people with emphysema have a rare inherited form of the disease called alpha 1-antitrvpsin (AAT) deficiency-related emphysema, or early onset emphysema. This form of disease is caused by an inherited lack of a protein called alpha 1-antitrypsin (AAT).
The prevalence of emphysema is fairly low in the general population (2 million). Unlike chronic bronchitis, the rates for emphysema have been consistently higher in males than in females. The rates decreased for males by about 52 percent (15.4 vs. 7.4 per 1,000), but increased slightly for females by about 19 percent (5.4 vs. 6.4 per 1,000) from 1982-1996 indicating that the gender disparity in the prevalence rates of emphysema over this period has decreased. The rates are higher in whites than in blacks. The prevalence rate for whites decreased by about 32 percent (11.4 vs. 7.7 per 1,000 population), but by only about 6 percent for blacks (3.4 vs. 3.2 per 1,000). The racial disparity in the prevalence rates for emphysema has also decreased due to a falling rate in whites.
Emphysema ranks ninth among chronic conditions that contribute to lack of activity: over 42% of individuals with emphysema report that their daily activities have been limited by the disease.
Many of the people with emphysema are older men, but the condition is increasing among women. Males with:
- Emphysema ranks ninth among chronic conditions that contribute to lack of activity: over 42% of individuals with emphysema report that their daily activities have been limited by the disease.
- Many of the people with emphysema are older men, but the condition is increasing among women. Males with emphysema outnumber females by 64%. National Heart, Lung, and Blood Institute 2003.
The FDA has determined that N115 has sufficient safety toxicology and clinical data to proceed with the multi-dose, extended use, clinical trials. Phase III/Phase IV studies will focus on asthmatics and COPD patients. On the basis of existing clinical data, EmphyCorp is confident that its Investigative New Drug, N115, can and will be used for maintenance or continuous treatment of patients over extended periods of time. The Company believes that N115 will set the standard in the pharmaceutical industry for the treatment of major pulmonary diseases.