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Cautionary Statement Regarding Forward-Looking Information
We are developing product candidates directed toward reducing the potent inflammatory response that is associated with the pathology, morbidity and, in some cases, mortality in many acute and chronic diseases. Our earlier product development programs center on controlling the production of potent inflammatory mediators that play a key role in regulating the body’s immune system. The cascading explosion of inflammatory mediators that occurs in many disease settings leads, in large part, to the uncontrolled, pathologic inflammation that can occur in trauma, infection, autoimmune, and allergic diseases. This cascade plays an important role in the severe inflammatory response seen in conditions that lead to admission to the intensive care unit (ICU), such as sepsis and septic shock, and acute exacerbations of chronic diseases that frequently lead to hospitalization, such as asthma, lupus, and rheumatoid arthritis.
In the setting of severe infection, trauma, severe bleeding or a lack of oxygen to the major organs of the body, the overproduction of inflammatory mediators, including cytokines, can lead to organ failure, tissue destruction and, eventually, death.
The individual programs within our portfolio, while targeted toward the inflammatory response, exert their effects through different mechanisms of action. These programs include:
•an alpha-7 nicotinic acetylcholine receptor program directed towards the discovery and development of novel, peripherally-acting, small molecule drugs that stimulate the cholinergic anti-inflammatory pathway to treat pathologic inflammation.
•an HMGB1 program focused on the discovery and development of therapeutic monoclonal antibodies directed towards the newly identified pro-inflammatory protein, HMGB1.
Additionally, we are developing an injectable formulation of zileuton for treatments directed toward the severe inflammatory response in acute diseases and conditions that lead to admission to the emergency room or intensive care unit.
We are also examining the pharmacokinetic and pharmacodynamic profile of the R(+) isomer of zileuton to determine if there are potential dosing improvements for patients. The successful development of the R isomer could lead to an enhanced intellectual property position of zileuton for the treatment of asthma and provide for possible development opportunities in other inflammatory diseases, including but not limited to Chronic Obstructive Pulmonary Disease (COPD), atherosclerosis and nasal polyps.
To protect and expand SPECTRACEF's market share, Cornerstone has also developed SPECTRACEF 400 mg, a higher dose tablet for the adult market, and is developing Spectracef Once Daily, a new oral solid dosage form, and SPECTRACEF Suspension, an oral suspension for the pediatric market.
CBP 058 is a combination methscopolamine and antihistamine product candidate that Cornerstone is developing for the treatment of symptoms of allergic rhinitis.
CBP 067 and CBP069 are extended-release antihistamine and antitussive, or cough suppressant, combination product candidates currently in development.
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