ABOUT CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

This disease includes chronic obstructive bronchitis and emphysema and is characterized by limited airflow accompanied by symptoms such as dyspnea (shortness of breath), cough, wheezing, and increased sputum production. COPD is a disease of the airways and alveolae characterized by progressive loss of lung function. This disease occurs mostly in smokers (80%) and often progresses even after smoking cessation. According to the World Health Organization, about 60 million people suffer from COPD, although many are undiagnosed. In the United States more than 20 million people suffer from COPD. This causes a significant financial burden; costing the U.S. economy more than $32 Billion in 2002 alone. Estimates are that by 2020, COPD will be the world's third leading cause of death.

There is no current medical therapy for COPD that affects prognosis. Inflammation is present within the airways of patients with COPD and is characterized by an increase in neutrophils, macrophages, and CD8+ T lymphocytes. This inflammation is different from that in asthma. It is believed that blocking the inflammatory cells that are present or the mediators that are released could prevent the progression of COPD.

TPI 1020

TPI 1020 (acquired from NicOx) has already undergone certain clinical and preclinical studies, including some in models of COPD. These studies suggested that TPI 1020 is more effective than budesonide alone in protecting against bronchoconstriction and in inhibiting the infiltration and subsequent activation of neutrophils in the lungs (neutrophils are immune cells implicated in COPD pathology). Using its proprietary discovery capabilities, Topigen confirmed that TPI 1020 inhibited the release of other mediators involved in COPD, where budesonide had no effect. TPI 1020 has completed a phase 1 study and a randomized, double-blinded, placebo controlled phase 2a study in asthmatic subjects. These results indicated that the drug is well tolerated, with a trend in activity and promising pharmacokinetic profile in asthma patients.

TPI 1100

Topigen is applying its unique multitargeted approach to the development of truly effective therapeutic products for the treatment of COPD with the objective of halting the progression of the disease. TPI 1100 is being developed to be specific, with broader effects than current therapies and has the potential of improving the prognosis of this chronic, debilitating and deadly disease.