Respiratory diseases such as bronchitis and chronic obstructive pulmonary disease (COPD) are triggered by atmospheric allergens, cigarette smoke and particulates. Intracellular oxidative stress also known as “redox stress” activates molecular mechanisms that lead to chronic inflammation of the entire lung and contribute to the development of COPD. Additional molecular mechanisms and the inflammation lead to increased sputum, coughing, loss of tissue elasticity, loss of lung volume and ultimately tissue necrosis. In patients with COPD, biomarkers of oxidative stress (hydrogen peroxide and 8-isoprostane, for example) are increased and provide evidence of the role of redox stress in the development of COPD.
The therapeutic goal for GVT® in the treatment of chronic bronchitis is to serve as adjunct therapy in the reduction or amelioration of hyper-inflammation and to increase the effectiveness of currently used drugs.
The target indication for GVT® includes use in refractory COPD patients in conjunction with current standards of care.
Non-clinical / Clinical Results.
GVT® has been studied in clinical trials for treatment in patients with chronic bronchitis. These early studies have provided evidence that GVT®:
Reduced inflammation in patients with chronic bronchitis
Was well tolerated when administered in an inhalation formulation
Produced a positive change in clinical symptoms, including:
Hyperemia
Edema
Purulent phlegm
Secretion amount
Viscosity
Study Name
Name of Research Institution and Principal Investigator (s)
Completion Date
Galavit® inhalations in complex therapy of a chronic bronchitis
Spaso- Perovsky Hospital of Peace and Charity, Russia
Pulmonology Department
Completed
Commercial Potential for GVT®
Large Market:
COPD affects approximately 24 million Americans and is the 4th leading cause of death in the United States behind heart disease, cancer and stroke
COPD is projected to become the 3rd leading cause of death in the United States by 2020
The current economic burden of COPD on the U.S. healthcare system is estimated to be over $30 billion annually
According to IMS Health (IMS), the current annual global market for COPD drugs is about $3 billion. It is projected to reach $9 billion by 2010 as safer and more effective drugs are introduced
Unmet Needs Remain:
Bronchodilators and anticholinergics are the most commonly prescribed therapies in COPD, but do not always address the underlying inflammation
These products are frequently employed in combination therapies along with glucocorticosteroids. Glucocorticosteroids have questionable efficacy and long-term side effects
